JUVELOOK

SAFETY GUIDELINE

From Prevention To Management

Healthcare Professional Only

Foreword

No medical product is entirely free from adverse events.

A good product, then, is one where —

Adverse events are uncommon

AEs are manageable

when they occur

Benefits outweigh�the concerns

Juvelook^® is such a product.

ABOUT THIS GUIDELINE

This guideline is provided for educational and clinical reference purposes. It compiles published clinical evidence and real-world case studies for the safe use of Juvelook^® and Juvelook^® Volume.

Clinical application of any specific indication, technique, or protocol should comply with applicable regulations and approved indications in the practitioner's jurisdiction. Practitioners are responsible for verifying local regulatory requirements and obtaining appropriate informed consent per their professional and jurisdictional standards.

2

VAIM | Juvelook Safety Guideline

Contents

01

High Safety of Juvelook

02

Possible Adverse Events

03

How to Prevent Adverse Events

04

How to Diagnose Adverse Events

05

How to Manage Adverse Events

06

Real-World Case Studies

07

Patient Education & Consent

3

VAIM | Juvelook Safety Guideline

PART 01

01

High Safety of Juvelook

3M+

Cumulative vials

produced (May 2026)

65+

Countries

exported worldwide

80

Countries

contracted

AMWC

AWARDS

Best Injectable

for Skin Revitalization

(Monaco 2025)

International Regulatory Certifications

Sources: VAIM Official Statement (Apr 2026); AMWC Monaco 2025; Regulatory filings on record.

5

PART 01 Global Track Record

VAIM | Juvelook Safety Guideline

Based on actual adverse event reports vs. total vials shipped

Juvelook® KEY METRICS

Total AE rate: 0.0075%�

Nodule rate: 0.0029%�

�

Particle size: 20–40 μm�

ZERO countercurrent flow in preclinical study

Source: VAIM Adverse Event Statistics 2023–2025 (Data on file).

6

PART 01 Adverse Event Statistics — Juvelook® (2023–2025)

VAIM | Juvelook Safety Guideline

Based on actual adverse event reports vs. total vials shipped

Juvelook Volume® KEY METRICS

Total AE rate: 0.0213%�

Nodule rate: 0.0163%�

​

Particle size: 40–60 μm�

Uniform particle dispersion needed

Source: VAIM Adverse Event Statistics 2023–2025 (Data on file).

7

PART 01 Adverse Event Statistics — Juvelook Volume® (2023–2025)

VAIM | Juvelook Safety Guideline

JUVELOOK PDLLA™ — Patented Bio-Interactive Particle Technology (KR102587872B1)

Bio-Interactive Particle → Regenerative Response

Direct Particle–Cell Interaction

Spherical + porous structure enables mechanical stimulus detected by Piezo1 mechanosensors on cells

M2 Macrophage Polarization

Pro-regenerative signaling pathway activated — NOT inflammatory M1. Results in tissue restoration, not fibrosis

Cell–Cell Interaction

M2 macrophages orchestrate fibroblast activation + adipose stem cell recruitment → collagen, elastin, adipogenesis

Lower Fibrosis Risk

Regenerative Foreign Body Reaction (FBR) > Inflammatory FBR. Histopathology: NO granuloma formation, PDLLA almost fully degraded at 5 months

Ref: Patent KR102587872B1; Hyeong JH, et al. Dermatol Surg. 2022;48(12):1306-1311.

8

Outer: Spherical and foamy shape

🡪 Minimize the damage to the surrounding tissue

​

Inner: Patented reticular and porous

🡪 Better biocompatibility and biodegradability

PART 01 Why Juvelook Is Safer — ① JUVELOOK PDLLA™ Patented Particle Design

VAIM | Juvelook Safety Guideline

Glass Transition Temperature (Tg) Comparison

9

Ref.> 1. Seo SB, et al. J Cosmet Dermatol. 2025;24(1):e16575. 2. Farah S, et al. Adv Drug Deliv Rev. 2016;107:367-392. 3. de França JOC, et al. Polymers (Basel). 2022;14(12):2317. 4. Cheng Z, et al. Biomaterials. 2004;25(11):1991-2001. 5. Erben J, et al. Polymers (Basel). 2022;14(24):5528. 6. Roudaut G, et al. Innov Food Sci Emerg Technol. 2004;5(2):127-134. 7. Ojovan MI. Entropy. 2008;10(3):334-364.

-100

-80

-60

-40

-20

0

20

40

60

80

100

120

140

180

160

Temp(℃)

PART 01 Why Juvelook Is Safer — ② Low Glass Transition Temperature

VAIM | Juvelook Safety Guideline

Glass Transition Temperature (Tg) Comparison

Ref: Seo SB, Wan J, Yi KH. J Cosmet Dermatol. 2025;24:e16575.

10

When hydrated, the glass transition temperature of PDLLA-HA drops from

50 °C to 39 °C.

Soften the mass of JUVELOOK particles by heating the nodule area with an Energy-Based Device at 40 °C.

Spread out the JUVELOOK particles into smaller masses by pressing down the nodule using fingers.

Due to its lower glass transition temperature (Tg), JUVELOOK allows non-invasive management of nodules using energy-based devices (e.g., HIFU, monopolar RF), followed by gentle manual massage.

🡪 The material softens upon heating, enabling easier remodeling.

Safety by

Design!

Dry PDLLA-HA particle

Hydrated PDLLA-HA particle

Soft PDLLA-HA particle

PART 01 Why Juvelook Is Safer — ② Low Glass Transition Temperature

VAIM | Juvelook Safety Guideline

The carrier matters as much as the active particle. Juvelook's HA carrier provides four scientifically-grounded safety advantages over CMC.

Hyaluronidase: the rescue advantage

When HA fillers cause vascular compromise, hyaluronidase rapidly depolymerizes the HA backbone, dissolving the embolus and restoring flow — often within minutes. This rescue pathway is unavailable with carboxymethylcellulose (CMC)-based biostimulators (CaHA, PLLA, PCL); management is limited to supportive measures (massage, nitroglycerin, aspirin) with substantially lower success rates.

PDLLA in HA ≠ PDLLA in CMC

Even with the same active particle (PDLLA microspheres), the choice of carrier fundamentally determines vascular safety. Juvelook's non-cross-linked HA carrier is degradable AND rescuable by hyaluronidase — making it the only PDLLA biostimulator with an enzymatic safety net, a property no CMC-based biostimulator can offer.

Sources: Sculptra Aesthetic FDA label (Galderma); Capuana E, et al. Polymers. 2022;14:1153; Ortiz E, et al. Ann Med Surg. 2022;83:104787; Hagiwara S, et al. ScienceDirect. 2024.

11

PART 01 Why Juvelook Is Safer — ③ Non-Cross-Linked HA Carrier

VAIM | Juvelook Safety Guideline

Two converging lines of evidence support the favorable vascular safety of Juvelook PDLLA-HA fillers.

20–60 μm

PDLLA particle size

vs. retinal artery ~160 μm

n = 112

Rabbit ear intra-arterial

0 sustained occlusion · 0 necrosis

20/250 → 20/50

PION case vision recovery

at 1 month follow-up

Why Juvelook + Juvelook Volume's vascular safety profile differs from other fillers

Small particle size (20–60 μm) — substantially smaller than the central retinal artery (~160 μm), allowing intravascular dispersion rather than sustained obstruction.

Non-cross-linked HA carrier — rapid enzymatic degradation; deformable and hyaluronidase-responsive (a rescue option that biostimulators with CMC carriers do not offer).

Biodegradable PDLLA microspheres — transient embolism may spontaneously dislodge as particles redistribute and degrade.

Preclinical: Rabbit Ear Intra-Arterial Model

• 112 rabbits (Juvelook 56 + Juvelook Volume 56), intra-arterial CEA injection
• 0.1 mL: smooth dispersion at all dilutions, no obstruction
• 0.2 mL undiluted: transient occlusion → spontaneous restoration within 5 min
• Dilution beyond 1:1 eliminated all flow disturbance
• Day 1 & Day 7: zero skin necrosis, zero intravascular thrombus, zero embolism (histopathology)

Clinical: PION Case (Joo & Kim, 2024)

• 36-yr male, after Juvelook Volume injection (orbital margin + nasolabial fold)
• Initial visual acuity 20/250 (right eye), afferent pupillary defect positive
• Diagnosis: Posterior Ischemic Optic Neuropathy (PION)
• Vision recovered to 20/50 at 1 month
• Authors propose: small particle size + rapid non-CL HA degradation enabled spontaneous emboli dislodging

Sources: Joo HJ, Kim DH. J Neuro-Ophthalmol. 2024; Chulalongkorn University rabbit ear study (n=112, manuscript in preparation).

12

PART 01 Vascular Safety Evidence — Juvelook(+Volume)'s Favorable Profile

VAIM | Juvelook Safety Guideline

PART 02

02

Possible Adverse Events

Five categories of adverse events have been reported with PDLLA-HA biostimulators. This part introduces what each looks like; prevention, diagnosis, and management are covered in Parts III–V.

Typical onset window

Immediate

minutes

Early

hours – days

Subacute

weeks – months

Late

months – years

Mild Reactions

Edema · Erythema · Ecchymosis · Allergic

Onset: Early

Lumps

Mechanical / technique-related

Onset: Early – Subacute

Nodules

Inflammatory or non-inflammatory

Onset: Subacute

Granulomas

Foreign-body reaction (rare, late)

Onset: Late

Vascular Occlusion

Most feared complication

Onset: Immediate

Source: Adapted from Magacho-Vieira & Ducati, J Cosmet Dermatol 2025; Parada et al., Surg Cosmet Dermatol 2016.

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PART 02 Overview — Categories of Possible Adverse Events

VAIM | Juvelook Safety Guideline

Mild reactions are the most common adverse events following any injectable procedure. They are typically transient, related to the injection itself rather than the product, and resolve spontaneously within days.

Edema

Localized swelling, most common at lips and periorbital areas. Influenced by needle gauge, injection speed, and volume.

Onset

Hours

Typical duration

Days

Erythema

Transient redness, especially after massage. Persistent erythema warrants exclusion of hypersensitivity or infection.

Onset

Immediate

Typical duration

Hours – days

Ecchymosis

Bruising from vessel trauma during injection. Risk reduced by avoiding anticoagulants pre-procedure and using blunt cannulas.

Onset

Hours

Typical duration

5–10 days

Allergic / Hypersensitivity

Acute reactions range from mild redness to anaphylaxis. Reported incidence with HA fillers ≈ 0.6%; ~50% transient.

Onset

Minutes – days

Typical duration

Variable

Sources: Parada et al., Surg Cosmet Dermatol 2016; Luebberding & Alexiades-Armenakas, J Drugs Dermatol 2012.

15

PART 02 Mild Reactions

VAIM | Juvelook Safety Guideline

Lumps are non-inflammatory, palpable irregularities caused by mechanical or technique-related factors. They typically lack phlogistic signs (warmth, redness, tenderness) and reflect physical placement rather than immune response.

Common Causes

1

Excessive volume

Too much product injected at a single point

2

Superficial placement

Product placed in dermis rather than intended deep plane

3

Product accumulation

Multiple boluses converging in one location

4

Migration

Muscle dynamics, gravitational pull, or vigorous post-procedural massage

Clinical Features

Palpability Firm, often visible only on palpation, occasionally raised

Phlogistic signs Absent — no warmth, redness, or tenderness

Onset Immediate to within first weeks post-injection

Distribution Localized to one or few injection points (vs. generalized)

Aesthetic impact Range from subtle to clinically obvious bumps

KEY DISTINCTION Lumps lack phlogistic signs. When warmth, redness, or tenderness appear, the differential shifts toward inflammatory nodules — covered next.

Sources: Magacho-Vieira & Ducati, J Cosmet Dermatol 2025; Parada et al., Surg Cosmet Dermatol 2016.

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PART 02 Lumps

VAIM | Juvelook Safety Guideline

Nodules are discrete subcutaneous masses that may appear immediately or weeks to months after injection. The presence or absence of phlogistic signs distinguishes the two main subtypes — a distinction central to diagnosis (Part IV).

Non-Inflammatory Nodules

Phlogistic signs

Absent — no warmth, redness, tenderness, or swelling

Pathophysiology

Mechanical accumulation or migration of product. May involve a localized fibrous tissue response without immune activation.

Clinical appearance

Firm, defined, non-tender. Typically restricted to specific injection sites.

Onset

Within several months of injection

Inflammatory Nodules

Phlogistic signs

Present — warmth, redness, tenderness, swelling

Pathophysiology

Three main subtypes: infectious (incl. biofilm), delayed hypersensitivity (T-cell type IV), and granulomatous reaction.

Clinical appearance

Erythematous, tender, sometimes fluctuant. May involve all areas treated with the offending filler.

Onset

Days to several years post-injection

→ Diagnostic differentiation by phlogistic signs and onset timing is detailed in Part IV.

Source: Magacho-Vieira & Ducati, J Cosmet Dermatol 2025;24:e70158.

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PART 02 Nodules

VAIM | Juvelook Safety Guideline

Granulomas are a distinctive form of late-onset chronic inflammation in which modified macrophages organize around persistent foreign material. They are uncommon — estimated 0.01–1% across all dermal fillers — but well-documented for PDLLA-based products.

0.01–1%

Estimated incidence

across all dermal fillers

T-cell IV

Hypersensitivity type

delayed cell-mediated

Weeks – Years

Onset window

wide variability reported

Pathophysiology

Cell-mediated foreign-body reaction. Persistent particle stimulus drives macrophage epithelioid transformation and multinucleated giant-cell formation around filler remnants.

Triggers proposed in literature: systemic infection, intense UV exposure, dental procedures, biofilm activation, or autoimmune predisposition.

Clinical Appearance

Firm, non-fluctuant nodules at injection sites. May enlarge gradually. Often described as "angry red bumps" when phlogistic signs are pronounced.

Frequently appears at all areas treated with the offending product, supporting an immune-mediated rather than purely mechanical etiology.

REPORTED ONSET RANGE PDLLA 2 months (Choi 2024) · PLLA 18 months (Jeon 2020) · PLLA 70 months (Storer 2016) — longest reported

Sources: Choi et al., Arch Aesthetic Plast Surg 2024;30(4):137; Jeon et al., Ann Dermatol 2020;32(6):519; Storer et al., JAAD Case Rep 2016;2:54; Parada et al., Surg Cosmet Dermatol 2016.

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PART 02 Granulomas

VAIM | Juvelook Safety Guideline

Vascular occlusion is the most feared complication in injectable aesthetics. It can occur with any filler, including PDLLA-HA. Early clinical recognition is the single most important factor in outcome.

62%

of experienced injectors report at least one intravascular event during their career

Clinical Recognition — 4 Cardinal Signs

1

Blanching

Sudden whitening of skin in distribution of injected vessel

2

Disproportionate pain

Severe, sharp, persistent pain — out of proportion to procedure

3

Livedo reticularis

Mottled, marbled, or bluish skin discoloration

4

Delayed capillary refill

Refill > 2 seconds after digital pressure (vs. normal 1–2 sec)

Untreated Progression — Time-Dependent

Blanching

minutes

Livedo / pain

minutes – hours

Bluish discoloration

hours

Blistering

hours – days

Necrosis / ulceration

days – weeks

JUVELOOK PROFILE Small particle size (20–60 μm), non-cross-linked HA carrier, and hyaluronidase-rescuable design support a favorable vascular safety profile — see Part I, Slide 11. Prevention and management protocols follow in Parts III & V.

Sources: King et al., J Clin Aesthet Dermatol 2020;13(1):E53; DeLorenzi, Aesthet Surg J 2014;34(4):584; Parada et al., Surg Cosmet Dermatol 2016.

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PART 02 Vascular Occlusion

VAIM | Juvelook Safety Guideline

PART 03

03

How to Prevent Adverse Events

Most PDLLA-HA adverse events are preventable. Six interdependent pillars drawn from the 2025 expert consensus (Lau et al.) and PDLLA reconstitution guidelines (Magacho-Vieira et al. 2024) are addressed in turn. Note: published consensus and dilution figures specifically address PDLLA-HA200 — Pillars 2 and 4 are revisited in product-specific form for Juvelook (PDLLA-HA50).

01

Reconstitution & Hydration

Full, homogeneous hydration.

No clumped particles.

02

Injection Plane

Juvelook Volume: subcutaneous only.

Juvelook: intradermal, subdermal, subcutaneous all OK.

03

Linear Retrograde + Fanning

≤ 0.1 mL per thread.

No bolus injection.

Fan to distribute particles.

04

Tools & Facial Anatomy

Juvelook Volume: cannula 23–25 G.

Juvelook: needle or cannula.

Map of safe / caution / avoid.

05

Treatment Interval

Juvelook: 6–8 weeks.

Juvelook Volume: 8–12 weeks.

Avoid cumulative overload.

06

Patient Selection

Screen contraindications.

Review medications & history.

Set realistic expectations.

Sources: Lau et al., J Craniofac Surg 2025; Magacho-Vieira et al., Clin Cosmet Investig Dermatol 2024.

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PART 03 Overview — Six Pillars of Prevention

VAIM | Juvelook Safety Guideline

VAIM produces two PDLLA-HA biostimulators with distinct particle profiles and clinical roles. Several prevention pillars — particularly injection plane and tool selection — diverge between the two. Internalize this distinction before reading Pillars 2 and 4.

Juvelook®

PDLLA-HA50 · Skin booster

20–40 μm

Smaller particle

APPROVED DEPTHS

✓

Intradermal

First PDLLA-class product cleared for intradermal injection.

✓

Subdermal

✓

Subcutaneous

✓

Deep layer

Recommended for thin-skin areas (under-eye, neck) — cannula at deep plane.

INSTRUMENT

Needle ✓ (30G preferred) Cannula ✓ (25 G preferred)

Skin texture, fine lines, hydration, periorbital, neck — thin-skin areas in particular.

Juvelook Volume®

PDLLA-HA200 · Volume biostimulator

40–60 μm

Larger particle

APPROVED DEPTHS

✗

Intradermal

Contraindicated — particle accumulation drives nodules and pearling.

△

Subdermal

✓

Subcutaneous

Primary plane — adequate dispersion volume.

△

Deep fat / supraperiosteal

Selected sites only.

INSTRUMENT

Needle ✗ Cannula ✓ (22–25 G preferred)

Volume restoration — temple, anterior/lateral cheek, sub-zygomatic, nasolabial fold.

Sources: Lau et al., J Craniofac Surg 2025; Magacho-Vieira et al., Clin Cosmet Investig Dermatol 2024; VAIM clinical guidance.

22

PART 03 Two Products, Two Profiles

VAIM | Juvelook Safety Guideline

Why this matters: homogeneous, fully hydrated PDLLA-HA suspension is the foundation of safe injection. Under-hydration concentrates particles at the needle tip and drives lump and nodule formation, while excessive (hyper-) dilution lowers viscosity and allows particles to drift and clump unevenly within the syringe. Proper mixing — not higher dilution — is the key to a uniform suspension.

Standard Reconstitution Protocol

1

Dilute per VAIM’s guideline — hyperdilution NOT recommended

Recommended: Juvelook 6 cc · Juvelook Volume 8–10 cc.

Hyperdilution lowers viscosity and lets particles drift and clump unevenly.

2

Mix gently before use

Use Hand or Vortex Mixing per protocol (see right). Visual check for uniform milky appearance with no settling.

3

Use within validated window

Discard any vial showing settling, clumps, or discoloration.

Recommended Mixing Methods (applicable from July 2026)

[ Hand Mixing ] N/S only

Juvelook · 2 min

Lenisna · 3 min

[ Vortex Mixing ]

Juvelook

10 min (VM J-3) / 15 min (VM JL-2)

Lenisna

20 min (VM J-3) / 40 min (VM JL-2)

After visual inspection, additional mixing may be performed if necessary.

If further vortex mixing is required, prolonged continuous operation should be avoided.

Common Reconstitution Errors

✗

Insufficient mixing time — particles still partially clumped at injection.

✗

Vigorous shaking — generates foam and uneven particle distribution.

✗

Hyperdilution — low viscosity allows particles to drift and clump unevenly.

✗

Prolonged continuous vortex operation — risks particle damage / heat.

✗

Re-using vial after settling without re-mixing — concentrated bottom fraction.

◀ Properly hydrated vial

- Uniform milky suspension;

ready for use.

Vortex Mixer — Version 3 (VM-J3).

Source: VAIM Research Institute Guide

23

PART 03 Pillar 1 — Reconstitution & Hydration

VAIM | Juvelook Safety Guideline

Plane recommendations diverge between the two products. Juvelook's smaller particle size permits intradermal placement — a first for any PDLLA-class product. Juvelook Volume's larger particle load mandates subcutaneous depth.

Source: Lau et al., Consensus Opinion on Safe Injection Technique, J Craniofac Surg 2025; VAIM clinical guidance.

24

epidermis

dermis

subcutaneous tissue

muscle

“JUVELOOK Volume” should not be injected into thin-skinned areas such as the periorbital region, and intradermal injection should be avoided.

PART 03 Pillar 2 — Injection Plane (Product-Specific)

VAIM | Juvelook Safety Guideline

⚠

Juvelook & Juvelook Volume are NOT HA fillers — they must NEVER be injected like an HA filler.

Juvelook

Needle · Intradermal

TECHNIQUE

Micro-droplet technique — small, evenly spaced deposits at the intradermal plane. No threading, no bolus.

DOSE PER POINT

0.01 mL per point — uniform, widely spaced grid.

ⓘ When a Cannula is used with Juvelook

• Tear trough · Neck wrinkles — Cannula required

• Skin rejuvenation — Cannula optional

→ Cannula technique: Linear retrograde + Fanning (per Juvelook Volume protocol)

Juvelook Volume

Cannula · Subcutaneous

TECHNIQUE

Linear retrograde + Fanning — inject only while withdrawing; multiple thin passes radiating from one entry point.

DOSE PER THREAD

≤ 0.1 mL per retrograde thread (often less).

Why bolus injection is the central risk — both products

✗

High-volume single-point delivery

Concentrates particle mass — substrate for lumps and nodules.

✗

Forward injection pressure

Generates head pressure that can drive intravascular entry.

✗

Documented in vision-loss cases

Bolus uniformly discouraged across published expert consensus.

✗

PDLLA is not reversible

Unlike HA, concentrated PDLLA cannot be enzymatically dissolved.

Bolus injection → Lump formation

Source: VAIM Research Institute Guide; published expert consensus.

25

✗

PART 03 Pillar 3 — Product-Specific Injection Technique

VAIM | Juvelook Safety Guideline

Adequate spacing between sessions is not a convenience — it is a safety parameter. PDLLA's biostimulatory effect develops gradually, and stacking sessions before the previous load has remodelled risks cumulative particle overload, lump formation, and over-correction.

Juvelook®

PDLLA-HA50 · Skin booster

MINIMUM INTERVAL

6 weeks

WHY THIS INTERVAL

Lower particle load (PDLLA-HA50). Subdermal placement for skin texture and hydration. Most patients require 3 sessions for full effect.

TYPICAL COURSE

Induction: 3 sessions, 6–8 wk apart. Maintenance: every 6 months.

Juvelook Volume®

PDLLA-HA200 · Volume restoration

MINIMUM INTERVAL

8 weeks

WHY THIS INTERVAL

Higher PDLLA load (170 mg) with deeper, subcutaneous placement. Longer remodelling phase before incremental top-up.

TYPICAL COURSE

Induction: 2–3 sessions, 8–12 wk apart. Maintenance: every 12 months or later, additional treatment may be considered if further volume restoration is needed, based on the physician’s clinical assessment.

⚠ Compressing intervals risks cumulative particle overload — a recognized contributor to nodule formation.

Sources: VAIM clinical practice guidance; Magacho-Vieira et al., Clin Cosmet Investig Dermatol 2024.

26

PART 03 Pillar 4 — Treatment Interval

VAIM | Juvelook Safety Guideline

The injection itself sits inside a larger clinical decision: is this patient a suitable candidate today? A structured pre-procedure history catches most disqualifying factors before the cannula is ever drawn.

✗

Absolute contraindications

Active infection

Local skin infection or systemic acute infection.

Hypersensitivity

Known allergy to PDLLA, HA, or any component.

Active autoimmune flare

Lupus, dermatomyositis, etc., in active phase.

Pregnancy / lactation

No safety data; defer treatment.

Bleeding disorders

Uncorrected coagulopathy.

△

Relative — proceed with caution

Anticoagulant / antiplatelet

Higher bruising risk; coordinate with prescriber.

Prior filler in same area

Establish what product, when, and where before layering PDLLA.

Recent dental / facial procedure

Increased biofilm risk; allow ≥ 2 weeks.

History of granulomas

Re-occurrence risk with any biostimulator.

Keloid / hypertrophic scarring

Atypical fibroblast response — counsel carefully.

✓

Routine pre-procedure history

Prior aesthetic procedures

Filler, biostimulator, energy device — type, date, area.

Current medications

Anticoagulants, immunosuppressants, isotretinoin.

Medical comorbidities

Diabetes, autoimmune disease, immunodeficiency.

Allergies

Including local anaesthetics.

Realistic expectations

Onset of effect is gradual; manage timeline expectations.

Sources: Lau et al., J Craniofac Surg 2025; Magacho-Vieira et al., Clin Cosmet Investig Dermatol 2024; VAIM clinical guidance.

27

PART 03 Pillar 5 — Patient Selection

VAIM | Juvelook Safety Guideline

PART 04

04

How to Diagnose Adverse Events

PDLLA-HA adverse events are best diagnosed by a sequenced decision process. The order matters — vascular emergencies must be ruled out first, then mass persistence, then phlogistic signs, then onset timing within the inflammatory branch.

STEP 1

Vascular emergency?

4 cardinal signs

(blanching, pain, livedo, refill delay)

STEP 2

Persistent palpable mass?

Distinguishes mild, transient reactions

from true lesions

STEP 3

Phlogistic signs?

Central diagnostic axis —

Inflammatory vs non-inflammatory

STEP 4

Onset timing?

≤2d · 2–15d · 16–90d · ≥90d

(inflammatory branch)

PRINCIPLE Stop at the first definitive step. Step 1 is binary and time-critical; subsequent steps refine the diagnosis only if the prior step was negative or did not yield management closure.

Adapted from: Magacho-Vieira & Ducati, J Cosmet Dermatol 2025;24:e70158; Lau et al., J Craniofac Surg 2025.

29

ⓘ

Vascular events are uncommon with Juvelook & Juvelook Volume — Step 1 is positioned first because, when it does occur, it is time-critical; not because it is frequent.

ⓘ Uncommon with Juvelook / Juvelook Volume — checked first only because it is time-critical.

PART 04 Overview — 4-Step Diagnostic Framework

VAIM | Juvelook Safety Guideline

Every other diagnostic step pauses if vascular occlusion is even possible. The therapeutic window is exceedingly narrow — irreversible retinal ischemia within 12–15 minutes — so this decision must precede all others.

1

Blanching

Sudden whitening of skin in the territory of the injected vessel.

2

Disproportionate pain

Severe, sharp, persistent — out of keeping with the procedure.

3

Livedo reticularis

Mottled, marbled, or bluish skin discolouration.

4

Delayed capillary refill

Refill > 2 seconds after digital pressure (normal 1–2 sec).

⚠ Time-critical decision

WINDOW

12–15 min

to permanent retinal damage from ophthalmic-circuit embolism. Even partial or intermittent occlusion can progress; vasospasm secondary to product irritation may extend the ischaemic territory beyond the embolised vessel.

Source: Tobalem et al., BMC Ophthalmol 2018 (cited in Lau et al. 2025).

Decision

ANY SIGN POSITIVE

STOP injection · See Part V immediately

ALL SIGNS NEGATIVE

Proceed to Step 2

When in doubt — treat as positive.

Sources: Lau et al., J Craniofac Surg 2025; Tobalem et al., BMC Ophthalmol 2018.

30

PART 04 Step 1 — Rule Out Vascular Emergency First

VAIM | Juvelook Safety Guideline

Most early adverse events are mild and transient. They may have inflammatory features (oedema, erythema), but they do not leave a lasting palpable lesion. The presence — or absence — of a persistent mass is the gate to the formal nodule pathway.

✓

No persistent mass → Mild reaction

Transient inflammatory features without a lasting palpable lesion.

TYPICAL PRESENTATIONS

Edema

onset Hours

duration Days

Erythema

onset Immediate

duration Hours – days

Ecchymosis

onset Hours

duration 5–10 days

Allergic

onset Min – days

duration Variable

ACTION

Reassure · symptomatic care · follow-up at expected resolution.

→

Persistent mass → Proceed to Step 3

Lasting palpable lesion beyond the expected mild-reaction window.

WHAT TO ASSESS

•

Palpability

Firm or rubbery; visible only on palpation, occasionally raised.

•

Persistence

Beyond expected mild-reaction duration (days for early, weeks for late).

•

Distribution

Localized to one or few injection points vs generalized.

•

Phlogistic signs

Warmth · redness · tenderness · swelling — assess in Step 3.

→ Move to Step 3: assess for phlogistic signs

Sources: Magacho-Vieira & Ducati, J Cosmet Dermatol 2025; Parada et al., Surg Cosmet Dermatol 2016.

31

PART 04 Step 2 — Persistent Palpable Mass?

VAIM | Juvelook Safety Guideline

The presence or absence of phlogistic signs splits the persistent-mass pathway into two distinct differential branches with different evaluation, prognosis, and management. This is the single most consequential decision in the diagnostic algorithm.

PHLOGISTIC SIGNS — the four cardinal features of inflammation

Color

Warmth

Dolor

Tenderness

Rubor

Redness

Tumor

Swelling

PHLOGISTIC SIGNS?

NO

Non-inflammatory pathway

Lump (early — immediate to weeks)

Mechanical / technique-related: excessive volume, superficial placement, product accumulation, or migration.

Non-inflammatory nodule (late — months)

Localized fibrous tissue response without immune activation. Firm, defined, non-tender; restricted to specific injection sites.

YES

Inflammatory pathway

Inflammatory nodule

Three sub-types — distinguished by onset timing in Step 4:

• Acute infectious (incl. biofilm)

• Delayed hypersensitivity (T-cell type IV)

• Granulomatous reaction

→ Move to Step 4: onset timing

Source: Magacho-Vieira & Ducati, J Cosmet Dermatol 2025;24:e70158.

32

PART 04 Step 3 — Phlogistic Signs (the Central Axis)

VAIM | Juvelook Safety Guideline

Within the inflammatory pathway, time-from-injection sub-classifies the lesion and points to the correct work-up. Magacho 2025 stratifies into four windows; each carries a different differential and immediate next step.

TIME FROM INJECTION

≤ 2 days

DIAGNOSIS

Acute inflammatory reaction

— routine post-procedure response

NEXT STEPS

•

Symptomatic treatment.

•

Reassess at 24 hours.

•

Escalate if persistent or worsening.

2 – 15 days

DIAGNOSIS

Probable acute infectious process

Fluctuance present?

NEXT STEPS

•

If fluctuant: drainage + culture (Ultrasound-guided).

•

If non-fluctuant: biopsy if severe inflammation.

•

Empiric antibiotic ≤ 72 h (e.g., clarithromycin + moxifloxacin).

16 – 90 days

DIAGNOSIS

Recent manipulation? → assess

Was the area manipulated post-injection?

NEXT STEPS

•

If yes: wait 24–48 h, reassess.

•

If no: consider delayed hypersensitivity.

•

Investigate triggers (infection, dental work, UV).

≥ 90 days

DIAGNOSIS

Delayed hypersensitivity / granulomatous

— T-cell mediated type IV reaction

NEXT STEPS

•

Investigate trigger factors.

•

Drainage / biopsy / culture as appropriate.

•

Intralesional or oral steroids; biofilm work-up if recalcitrant.

Source: Magacho-Vieira & Ducati, Clinical Management of PDLLA Nodules, J Cosmet Dermatol 2025.

33

PART 04 Step 4 — Onset Timing (Inflammatory Branch)

VAIM | Juvelook Safety Guideline

All four steps assembled into a single decision tree. Stop at the first definitive outcome.

Suspected PDLLA-HA Adverse Event

↓

1. Vascular emergency signs?

YES

STOP → Part V immediate management

NO ↓

2. Persistent palpable mass?

NO

Mild reaction → reassure, monitor

YES ↓

3. Phlogistic signs?

NO

Lump / Non-inflammatory nodule

YES ↓

4. Onset timing?

↓

≤ 2 days

Acute reaction

2–15 days

Acute infection

16–90 days

Delayed hypers.

(post-manipulation)

≥ 90 days

Delayed hypers. /

granulomatous

Adapted from: Magacho-Vieira & Ducati, J Cosmet Dermatol 2025; Lau et al., J Craniofac Surg 2025.

34

PART 04 Integrated Diagnostic Flowchart

VAIM | Juvelook Safety Guideline

Magacho 2025 anchors imaging on high-frequency ultrasound — accessible, dynamic, and uniquely able to characterize fillers and their complications. MRI/CT and histopathology are reserved for scenarios where ultrasound is inconclusive.

FIRST-LINE

High-frequency ultrasound (HFUS)

WHEN

All persistent masses; suspected abscess, fluid collection, or filler-related lesion.

WHAT IT SHOWS

•

Filler depth, distribution, and integrity.

•

Fluid collections and abscess cavities.

•

Vascular flow (Doppler) — adjacent vessels.

•

Real-time guidance for drainage / injection.

LIMITATIONS

Operator-dependent; deeper or bony-overlapped lesions may need cross-sectional imaging.

SECOND-LINE

MRI / CT

WHEN

Sonographic findings inconclusive or further anatomic detail required (deep planes, periorbital, perineural extension).

WHAT IT SHOWS

•

Superior soft-tissue contrast (MRI).

•

Bony-anatomic relationships (CT).

•

Lesion extent for surgical planning.

•

Excludes deep mimics (cysts, tumours).

LIMITATIONS

Cost, access, contrast considerations; not real-time.

LAST RESORT

Histopathology

WHEN

History and imaging both inconclusive; high suspicion of non-PDLLA pathology (malignancy, lymphoma, granulomatous disease).

WHAT IT SHOWS

•

Definitive tissue diagnosis.

•

Differentiates infectious vs sterile granuloma.

•

Identifies T-cell hypersensitivity patterns.

•

Confirms or excludes malignant mimics.

LIMITATIONS

Invasive; may seed infection or distort the lesion architecture.

Sources: Magacho-Vieira & Ducati, J Cosmet Dermatol 2025; Wortsman, J Ultrasound Med 2015; Cavallieri et al., Semin Ultrasound CT MR 2024.

35

PART 04 Imaging — Sonography First

VAIM | Juvelook Safety Guideline

Not every firm subcutaneous lesion in a previously injected face is filler-related. Magacho 2025 names four diagnostic mimics specifically; missing any of these can lead to mis-treatment, delayed oncological diagnosis, or unwarranted excision.

Cutaneous calcinosis

CLINICAL FEATURES

Firm, gritty, sometimes ulcerated; calcium salt deposition.

DISTINGUISHING

Plain X-ray or Ultrasound shows acoustic shadowing from calcification.

Epidermoid cyst

CLINICAL FEATURES

Discrete, mobile, often with central punctum; slow-growing.

DISTINGUISHING

Ultrasound: well-defined, hypoechoic, posterior enhancement; may have visible punctum.

Nodular basal cell carcinoma

CLINICAL FEATURES

Pearly papule with telangiectasias; may ulcerate centrally.

DISTINGUISHING

Surface dermoscopy (arborizing vessels); biopsy confirms.

Pseudolymphoma

CLINICAL FEATURES

Reactive lymphoid hyperplasia; firm erythematous nodule(s).

DISTINGUISHING

Histopathology required; mimics inflammatory nodule clinically.

Foreign-body granuloma

(non-PDLLA filler)

CLINICAL FEATURES

Late-onset firm nodule(s) at prior filler sites.

DISTINGUISHING

Detailed product history; HFUS may identify residual filler echo signature.

Subcutaneous abscess (non-filler)

CLINICAL FEATURES

Tender, fluctuant, erythematous; systemic signs possible.

DISTINGUISHING

Ultrasound: anechoic / mixed-echo cavity; aspiration culture confirms.

Sources: Magacho-Vieira & Ducati, J Cosmet Dermatol 2025; Magacho-Vieira & Santana, Clin Cosmet Investig Dermatol 2023.

36

PART 04 Differential Diagnosis — Don't Miss the Mimics

VAIM | Juvelook Safety Guideline

PART 05

05

How to Manage Adverse Events

Each adverse-event category has a different therapeutic axis. Mismatching axis — for example, applying hyaluronidase to a fibrous PDLLA nodule, or applying RF during active inflammation — is a common error and can worsen the outcome.

Vascular emergency

TIME-CRITICAL MULTISTEP PROTOCOL

Hyaluronidase flooding · IOP-lowering · steroid · transfer for HBOT.

Mild reactions

CONSERVATIVE / SYMPTOMATIC

Ice · antihistamines · short oral steroid if severe · time.

Lumps (early)

MECHANICAL

Massage · saline injection · Ultrasound-guided subcision.

Non-inflammatory nodules (late)

ENERGY-BASED + SALINE

RF / HIFU exploiting PDLLA glass transition (38–39 °C).

Inflammatory nodules (infectious)

ANTIBIOTICS ± DRAINAGE

Macrolide + quinolone · drainage if fluctuant · biofilm work-up.

Granuloma /

delayed hypersensitivity

STEROID-FIRST + JAK IF REFRACTORY

Intralesional triamcinolone · oral prednisone · JAK inhibitors.

Sources: Lau et al., J Craniofac Surg 2025; Magacho-Vieira & Ducati, J Cosmet Dermatol 2025; Parada et al., Surg Cosmet Dermatol 2016.

38

PART 05 Overview — Treatment Landscape by AE Category

VAIM | Juvelook Safety Guideline

12–15 minutes to permanent retinal damage. Phases below run in parallel where possible. Hyaluronidase works on the HA carrier (Juvelook hybrid) and on adjacent dermal HA — particle redistribution rather than dissolution is the goal.

PHASE 1 · 0–5 min

Recognise · Stop · Position

PHASE 2 · 5–15 min

Pharmacologic intervention

PHASE 3 · Transfer / hospital

HBOT · invasive measures

STOP

Cease injection at first suspicion.

POSITION

Patient supine; assess vision and skin colour.

CALL

Activate emergency response · prepare Hyaluronidase.

MASSAGE

Ocular massage if eye involvement (10s on / 10s off).

ASSESS

Document time of onset · cardinal signs.

HYALURONIDASE FLOODING

≥ 1500 IU subcutaneous at injection site + glabella · repeat every 60 minutes.

IOP-LOWERING

Topical timolol · oral / IV acetazolamide if eye involvement.

ANTI-COAG

Aspirin 300 mg oral loading · daily 100 mg × 7 days.

STEROID

Dexamethasone 8 mg intramuscular (anti-oedema).

VASODILATION

Paper bag CO₂ rebreathing · sildenafil consider (off-label).

URGENT TRANSFER

Ophthalmology / vascular centre.

HBOT

Hyperbaric oxygen — improves tissue oxygenation.

ANT. CHAMBER PARACENTESIS

Trained operator only.

WOUND CARE

Daily dressing · low molecular weight heparin · serial photos.

FOLLOW-UP

Daily review until resolution / stabilization.

Sources: Lau et al., J Craniofac Surg 2025; Parada et al., Surg Cosmet Dermatol 2016; Tobalem et al., BMC Ophthalmol 2018.

39

PART 05 Vascular Emergency — Stepwise Protocol

VAIM | Juvelook Safety Guideline

Two non-overlapping situations that look alike at presentation. Mild reactions are transient and need only symptomatic care. Lumps need active mechanical management — surgical excision is rarely required as PDLLA is bioresorbable.

Mild reactions — conservative

Transient; resolves within hours to days.

Edema

Cold compress · antihistamine · head elevation.

Erythema

Cool compress · topical low-potency steroid · antihistamine.

Ecchymosis

Time · arnica · vitamin K cream.

Allergic

Antihistamine · short oral steroid taper if severe.

Escalation triggers: persistence > expected window, fluctuance, fever, spreading erythema

→ re-evaluate as infection or hypersensitivity.

Lumps — mechanical ladder

Early-onset focal accumulations (FAs); no phlogistic signs. PDLLA is bioresorbable — mechanical dispersion is first-line; surgical excision rarely needed.

1

Mechanical dispersion (Level 1)

Vigorous massage — patient self-massage 3×/day for 1 wk; ± in situ hyperdilution: inject sterile water (preferred) or saline directly into lump + immediate vigorous massage. Voigts 2010: sterile water + massage ≈ 35% reduction.

2

Ultrasound-guided needle subcision (Level 1)

25–27 G needle under sonography; release adhesions, inject 0.5–1 mL diluent. Combine with massage to enhance dispersion.

3

Energy-based device (Level 2) ⓘ

Monopolar RF heating to 38–39 °C + manual massage — leverages PDLLA's glass-transition softening to non-invasively reshape the lump. Case-report level evidence (Seo 2025); pending broader validation.

4

Surgical excision — last resort (Level 3)

Rarely needed for PDLLA; polymer is bioresorbable. Reserve for refractory cases with significant aesthetic impact.

Sources: McCarthy et al., Aesthet Surg J 2024;44:869–879 · Voigts et al., Dermatol Surg 2010;36:798–803 · Magacho-Vieira & Ducati / Seo et al., J Cosmet Dermatol 2025 · VAIM Research Institute Guide.

40

PART 05 Mild Reactions & Lumps

VAIM | Juvelook Safety Guideline

PDLLA's uniquely low glass-transition temperature (38–39 °C) makes radiofrequency, HIFU, and microwave devices effective for thermal degradation

— a property not shared by PLLA (60 °C) or by other biostimulators.

Why PDLLA responds to heat

PDLLA

38 – 39 °C

porous, hydrated → softens at body-near temperature

PLLA

≈ 60 °C

dense, only softens at burn-range heat

MECHANISM

Heating PDLLA to 38–39 °C softens the porous microspheres, allowing manual reshaping and gradual breakdown. Multifrequency RF may additionally induce M2 macrophage polarization, supporting remodelling.

​

Caution — heat too aggressive may accelerate breakdown and trigger new inflammation. Raise temperature gradually with thermometer monitoring.

Treatment ladder — superficial Juvelook nodules

STEP 1

First-line (superficial Juvelook only)

Hyaluronidase + weak intralesional steroid.

Hyaluronidase degrades the HA carrier component (Juvelook is hybrid PDLLA-HA), reducing volume; steroid calms local inflammation. Not for granuloma. — Dr. Seo

STEP 2

2 weeks later — if persistent

Normal saline injection at the lesion (lowers glass-transition threshold) + monopolar RF to thermal degradation.

STEP 3

Energy-based protocol

Monopolar RF 1–2 MHz · 150 shots · 115 J · 28.75 J/cm² (4 cm² tip) · surface 41–42 °C · strong post-treatment compression. — Seo, Wan, Yi 2025

STEP 4

Adjuncts

HIFU circular probe · multifrequency RF · MNRF. All exploit the same glass-transition principle.

Sources: Seo, Wan, Yi, J Cosmet Dermatol 2025;24:e16575; Dr. Sukbae Seo clinical guidance; Magacho-Vieira & Ducati 2025.

41

PART 05 Non-Inflammatory Nodules — Energy-Based Devices

VAIM | Juvelook Safety Guideline

Onset 2–15 days with phlogistic signs raises infection probability. Treat empirically while culture is pending.

Biofilm is a recognized chronic substrate and demands different, longer therapy.

Acute infection — empiric therapy

•

Empiric antibiotic

Macrolide ± fluoroquinolone — clarithromycin 500 mg twice daily + moxifloxacin or 3rd-generation cephalosporin. Start within 72 h of suspicion.

•

Culture and sensitivity

Aspirate / swab before initiating antibiotics where feasible. Atypical mycobacteria possible after 2 weeks.

•

Drainage if fluctuant

Ultrasound-guided drainage of fluid collections / abscesses.

•

Reassess at 72 h

If no improvement → escalate antibiotic, biopsy, broaden coverage.

•

Doxycycline option

For atypical and biofilm-related pathogens.

Biofilm — chronic / recurrent

Bacteria-secreted matrix shielded from antibiotics and immunity. Suspect when: chronic, recurrent after antibiotic course, negative cultures, granulomatous response.

•

Dual broad-spectrum × 6 weeks

Quinolone (ciprofloxacin) + macrolide (clarithromycin). Macrolides accumulate in subcutaneous fat — superior biofilm penetration.

•

Imaging guidance

Ultrasound / MRI to localize · PET-CT can identify foci of infection.

•

Avoid steroids and NSAIDs

Mask infection and may worsen if biofilm is the substrate.

•

Consider intralesional 5-FU

Interferes with biofilm regulatory genes (AriR).

Sources: Magacho-Vieira & Ducati 2025; Parada et al., Surg Cosmet Dermatol 2016;

42

PART 05 Inflammatory Nodules — Acute Infectious / Biofilm

VAIM | Juvelook Safety Guideline

Late onset (≥ 90 days) with phlogistic signs and a fibrous palpable mass. Hyaluronidase is NOT first-line

— PDLLA microspheres do not dissolve enzymatically. Intralesional and systemic steroids are the mainstay; choice between agents matters.

Intralesional steroid — agent selection

Triamcinolone acetonide

Powder · mild acidic

Tissue retention

Prolonged — single dose lasts weeks.

Concentration

5–10 mg/mL standard; up to 20 mg/mL.

Schedule

Every 2–4 weeks · 4 sessions typical.

Evidence

4 sessions every 2 weeks → resolution.

— Perez Willis 2024

Caution

Atrophy if too superficial.

Betamethasone NaP

Solution · alkaline

Tissue retention

Limited — solution diffuses quickly.

Concentration

Diluted 1:30–40, 0.1–0.3 mL / nodule.

Schedule

Weekly · 8–10 sessions typical.

Evidence

Dr. Jung Case B — 10 sessions → subsided.

Caution

Frequent dosing; pair with short oral steroid.

Systemic & adjunctive

•

Oral prednisone

Start 30 mg/day (or 0.5–1 mg/kg/day, up to 60 mg).

Taper over 6–9 weeks.

•

Antibiotic adjunct

Minocycline 100 mg twice daily or doxycycline

— anti-inflammatory + biofilm coverage.

•

Antimalarials

Hydroxychloroquine 4–6.6 mg/kg/day for refractory cases.

•

Allopurinol

Adjunct for multiple lesions (anti-inflammatory pathway).

•

Surgical excision

Last resort. Avoid during active inflammation

— fistula and migration risk.

Sources: Perez Willis & Ramirez, Case Rep Dermatol Med 2024; Magacho-Vieira & Ducati 2025; Parada et al. 2016;

43

PART 05 Granuloma & Delayed Hypersensitivity — Steroid-First

VAIM | Juvelook Safety Guideline

When granuloma persists despite optimised steroid therapy, JAK-STAT pathway inhibition has emerged as an effective alternative. Six published cases (2024–2025) report 100 % resolution with no treatment-related adverse events.

Mechanism — multi-level immunomodulation

•

T cell – macrophage homeostasis

JAK-STAT inhibition disrupts persistent immune activation.

•

STAT6-dependent MGC formation

Suppresses multinucleated giant cell fusion (IL-4 / IL-13).

•

Fibrosis cytokines

Transcriptionally inhibits TGF-β1, IL-13, IL-4, CSF-1.

•

M1 macrophage markers

Downregulates TNFα, CXCL10, NOS2.

•

IFN-γ – driven granulomatous loop

Blocks the sustaining cytokine signal.

Protocol — Fu et al. 2025 (J Cosmet Investig Dermatol)

Abrocitinib 100 mg oral once daily + Prednisone 30 mg taper over 9 weeks

Resolution at 13 weeks. Monitoring weekly with clinical photography, dermoscopy, RCM, multispectral imaging. CBC + LFTs at baseline and during therapy.

PUBLISHED CASES (2024–2025)

Mansouri 2024 (Iran)

Tofacitinib 5 mg twice daily

12-month resolution

Wang 2024 (China, n=3)

Tofacitinib 5 mg once or twice daily

Complete resolution

Ianhez 2024 (Brazil)

Tofacitinib 5 mg twice daily

12-month resolution

Yang 2024 (China)

Abrocitinib 100 mg + prednisone

6 months

Lopez 2024 (USA)

Abrocitinib + fexofenadine

2 months

Li 2025 (China)

Abrocitinib + methylprednisolone

2 months

CAUTIONS · CYP3A4 metabolism — avoid concomitant clarithromycin, itraconazole · Infection / cardiac / clot risks · Specialist supervision required.

Sources: Fu et al., Clin Cosmet Investig Dermatol 2025;18:1199; Wang, Mansouri, Ianhez, Yang, Lopez, Li 2024–2025; Dr. Sukbae Seo (Rinvoq® / upadacitinib).

44

PART 05 Refractory Cases — JAK Inhibitors

VAIM | Juvelook Safety Guideline

Patients with autoimmune markers (ANA+, TPO+, uncontrolled hypothyroidism) develop a delayed inflammatory nodule (DIN) variant that does NOT respond to standard protocols. Modify the treatment substantially — and stabilize the underlying autoimmune background.

Recognition

•

Autoimmune markers

ANA positive (e.g., 1:160) · elevated TPO antibody.

•

Endocrine status

Uncontrolled hypothyroidism increases susceptibility.

•

Ultrasound

Hypoechoic nodules with mild Doppler activity = inflammatory PDLLA aggregates.

•

Pattern

Multiple sites · diffuse · responds poorly to standard steroids alone.

•

Trigger to suspect

Failure of typical treatment over 3–4 sessions in a young female patient.

Modified protocol — 6-step over 8–12 weeks

1

Low-dose intralesional steroid

Triamcinolone 2.5 mg/mL · 0.05–0.1 mL per point · every 2 weeks only. Avoid high-dose / frequent dosing.

2

Saline flooding on alternate weeks

0.5–1 mL per nodule. Mechanical dilution + lymphatic clearing — safe and repeatable.

3

SUSPEND RF / heat-based therapy

4–6 weeks until inflammation stabilizes. RF during active inflammation worsens tissue stress.

4

Autoimmune control in parallel

Refer endocrinology for thyroid optimization · address ANA-associated activity. Critical for prognosis.

5

Ultrasound-guided subcision once stabilized

25–27 G needle · gentle adhesion release + saline. Without triggering immune flare.

6

Reassessment

Clinical + sonographic every 2 weeks · 8–12 weeks expected for resolution · re-introduce RF only after stabilization.

Source: Ecuador case treatment guide — DIN with autoimmune background (ANA+, TPO+, hypothyroidism).

45

PART 05 Special — Autoimmune-Background DIN

VAIM | Juvelook Safety Guideline

Adapted from Magacho-Vieira & Ducati 2025 Figure 1

⚠

KEY PRINCIPLES ① Confirm PDLLA-related (rule out calcinosis · cyst · BCC · pseudolymphoma via ultrasound).

② PDLLA ≠ HA — no hyaluronidase. ③ PAUSE heat/RF/massage during active inflammation. ④ PDLLA bioresorbable — surgical excision rare.

PHLOGISTIC SIGNS (warmth · redness · tenderness · swelling) ?

NO

YES

Non-inflammatory nodule (Focal Accumulation / maldistribution)

Inflammatory nodule → classify by TIME OF ONSET

Responds POORLY to corticosteroids (Magacho-Vieira 2025) — mechanical / energy-based is first-line.

Sub-classify:

• Asymptomatic + not visible → Observe (self-resolves 1–5 yr); patient massage if onset <1 mo.

• Symptomatic / visible → Treatment ladder below.

TREATMENT LADDER (Magacho-Vieira / McCarthy ascending)

1

Vigorous massage + saline injection · first-line, non-invasive

2

RF / HIFU / Microwave 38–40 °C + massage · Tg leverage (115 J, 28.75 J/cm²)

3

Ultrasound-guided needle subcision · 25–27 G + sterile water / saline / 5-FU

4

Special — superficial Juvelook (HA displaced) · Hyaluronidase + weak steroid 1st-line

5

Surgical excision · absolute last resort; PDLLA bioresorbable

DAYS – WEEKS Infectious (abscess possible)

Tender, erythematous swelling; may progress to abscess.

→ Culture (before antibiotic ideally) · Broad-spectrum antibiotic

→ Ultrasound-guided drainage if abscess · Escalate antibiotic if no improvement at 72 h.

3 MONTHS – YEARS Delayed Hypersensitivity ('angry red bumps')

T-cell type IV reaction; may progress to granulomatous.

→ Fluorinated corticosteroid (oral or intralesional) · Broad-spectrum antibiotic if biofilm suspected

PAUSE heat / RF / aggressive massage during active phase.

If autoimmune (ANA+, thyroid): refer endocrinology; consider Rinvoq®

6 – 24 MONTHS Granulomatous nodule

Firm, non-fluctuant, gradually enlarging. Responds well to intralesional steroids.

→ Intralesional Triamcinolone 2.5 mg/mL, micro-depot 0.05–0.1 mL/point, every 2 weeks

→ Short oral prednisone taper (20 mg × 3 d, then 10 mg × 2 d) if extensive

→ Histopathology to differentiate from infectious (Perez Willis 2024).

REFRACTORY → re-confirm differential dx · biofilm work-up (culture + broad-spectrum antibiotics) · consider Rinvoq® / JAK inhibitor · surgical excision = absolute last resort.

PREVENTION → reconstitution per IFU (Pillar 1) · no bolus (Pillar 3) · layer-appropriate technique · Mannitol 20% pre-hydration for high-risk anatomy.

Sources: Magacho-Vieira & Ducati, J Cosmet Dermatol 2025;24:e70158 (Figure 1 base) · Dr. Seo’s clinical protocols · McCarthy et al., Aesthet Surg J 2024 · Seo et al., J Cosmet Dermatol 2025 · Perez Willis & Ramirez 2024 · Bartus et al., Dermatol Surg 2013 (PLLA experience) · VAIM Research Institute Guide.

46

PART 05 VAIM Nodule Management Algorithm

VAIM | Juvelook Safety Guideline

These are the most common errors when managing PDLLA-HA adverse events. Each represents a scenario where intuitive choice based on HA filler experience fails — or actively worsens — the outcome.

✗

Don't use Hyaluronidase for PDLLA granuloma

PDLLA microspheres do not dissolve enzymatically.

Use intralesional / oral steroids first. — Magacho 2025

Note: Hyaluronidase is appropriate for vascular emergency (HA carrier degradation) and for superficial Juvelook lumps (HA component, with weak steroid). Different scenarios.

✗

Don't apply RF during active inflammation

Heat increases tissue stress — worsens immune flare.

SUSPEND RF / heat-based therapy until inflammation stabilizes (typically 4–6 weeks). — Ecuador autoimmune protocol

✗

Don't use steroids if biofilm is suspected

Steroids and NSAIDs can mask infection and worsen biofilm.

Treat empirically with dual antibiotics (quinolone + macrolide) for up to 6 weeks before considering anti-inflammatory therapy.

✗

Don't excise during active inflammation

Triggers filler migration · fistula · scar.

Surgical excision is a last resort. Defer until inflammation has been controlled for at least 4–6 weeks.

✗

Don't expect resolution in 3–4 sessions

Realistic course is 8–12 weeks for inflammatory nodules.

Communicate this to the patient up-front. Multi-session reality is the norm — patient reassurance is part of the protocol. — Dr. Seo

✗

Don't raise temperature aggressively

Burn risk · accelerated particle breakdown → new nodules.

Raise gradually with thermometer monitoring. Surface 41–42 °C target. Apply locally only to the nodule.

Sources: Magacho-Vieira & Ducati 2025; Parada et al. 2016; Seo, Wan, Yi 2025; Ecuador autoimmune-DIN guide; Dr. Sukbae Seo clinical know-how.

47

PART 05 Pitfalls & Contraindications — What NOT to Do

VAIM | Juvelook Safety Guideline

AE category × treatment axis at a glance. Use as a decision guide once diagnosis (Part IV) is established. Spelled-out terminology throughout for international clarity.

AE Category → First-line → Adjuncts → Refractory / Special

AE CATEGORY

FIRST-LINE

ADJUNCTS

REFRACTORY / SPECIAL

Vascular emergency

Hyaluronidase flooding ≥ 1500 IU + IOP-lowering

Aspirin · steroid · sildenafil · transfer to specialist

Hyperbaric Oxygen Therapy (HBOT) · paracentesis (specialist)

Mild reactions

edema · erythema · ecchymosis

Conservative (cold compress · antihistamine)

Topical low-potency steroid · short oral steroid taper

Re-evaluate as infection / hypersensitivity

Lumps (early, no inflammation)

Focal Accumulation (FA)

Mechanical dispersion: vigorous massage + saline injection

Energy-based: RF / HIFU / Microwave 38–40 °C + massage · Ultrasound-guided subcision (25–27 G)

Surgical excision — last resort (PDLLA bioresorbable)

Non-inflammatory nodule

responds POORLY to corticosteroids

Mechanical (massage + saline) + RF / HIFU / Microwave 38–40 °C

Ultrasound-guided subcision · Superficial Juvelook (HA displaced): Hyaluronidase + weak steroid 1st-line

Multifrequency RF · HIFU · Microneedle RF (MNRF)

Inflammatory — infectious

days – weeks post-injection

Culture (when possible) + broad-spectrum antibiotic

Ultrasound-guided drainage if fluctuant · escalate antibiotic at 72 h if no improvement

Biofilm protocol: dual broad-spectrum antibiotics × 6 weeks

Granuloma / late hypersensitivity

3 months – 24 months post-injection

Intralesional Triamcinolone 2.5 mg/mL micro-depot, every 2 weeks × 4

Short oral prednisone taper (20 mg × 3 d, 10 mg × 2 d) · minocycline · hydroxychloroquine

JAK inhibitor: Rinvoq® (upadacitinib) or abrocitinib + prednisone

Autoimmune-background DIN

Delayed Inflammatory Nodule, autoimmune-prone

Low-dose Triamcinolone 2.5 mg/mL every 2 weeks + saline alternating weeks

PAUSE heat / RF during active inflammation · endocrinology / rheumatology referral; thyroid panel

Rinvoq® / JAK inhibitor · Ultrasound-guided subcision after stabilization

End of Part V.

48

PART 05 Summary — Treatment Matrix

VAIM | Juvelook Safety Guideline

PART 06

06

Real-World Case Studies

Five cases spanning the spectrum of PDLLA-related adverse events. Every case resolved without surgery — some within 24 hours, others required patience over months. Use as pattern-recognition reference and protocol guide.

#

CASE

DIAGNOSIS

TREATMENT

OUTCOME

1

Tear trough nodule

wrong-product selection

Non-inflammatory FA (3 wk onset)

Monopolar RF + compression

24 hours

2

Mandibular granuloma

late-onset, 4 months

Granuloma (4 mo onset)

Intralesional Triamcinolone + oral prednisone

4 sessions

3

Autoimmune-background nodule

ANA+, thyroid dysfunction

DIN with autoimmune comorbidity

Low-dose Triamcinolone + saline alt-weeks; PAUSE heat

Stabilized

4

Late-onset temple nodule

1 year post-injection

Late-onset subcutaneous nodule

Oral steroid + Doxycycline + intralesional Betamethasone × 10

10 sessions

5

Refractory granuloma

JAK inhibitor escalation (non-PDLLA reference)

Refractory FBG (steroid-resistant)

Abrocitinib + prednisone (tapered)

13 weeks

Common thread: Every case ended without surgery. Timeframes varied from 24 hours to 5+ months. The variable was patience and protocol fidelity — not whether resolution was achievable.

Source: Compiled from Seo 2025 · Perez Willis 2024 · Dr. Seo’s Ecuador case· Fu et al. 2025.

50

PART 06 Five Illustrative Cases — Overview

VAIM | Juvelook Safety Guideline

PATIENT

42 y/o female · bilateral tear trough · treated with Juvelook Volume (wrong product selection — Juvelook Volume's 40–60 μm particles are not for thin-skin areas) · onset 3 weeks post-injection

PRESENTATION & DIAGNOSIS

Presentation: Firm, hardened, visible bilateral tear trough nodules. No erythema, no tenderness, no fluctuance. Minor surrounding soft tissue swelling. No systemic symptoms.

Diagnosis: Non-inflammatory Focal Accumulation (FA). Ultrasound: hyperechoic foci,

no Doppler activity. No phlogistic signs → mechanical / energy-based pathway.

CLINICAL ILLUSTRATIONS

BEFORE

AFTER

TREATMENT PROTOCOL

1

Monopolar RF, session 1

150 shots · 4 cm² tip

Energy: 115 J (28.75 J/cm²)

Reduce to 95 J → 75 J if patient discomfort

2

Strong manual compression

Immediately after RF

Applied directly to treated nodule area

(promotes Tg-softened particle redistribution)

3

Session 2 (repeat)

Same parameters as session 1

After assessment of session-1 response

No additional adjuncts needed

OUTCOME Complete resolution within 24 h of session 2.

No recurrence at follow-up.

KEY TAKEAWAY Right product for right anatomy: Juvelook (20–40 μm) is for thin-skin areas including tear trough; Juvelook Volume (40–60 μm) is for deeper volumization only. When non-inflammatory FA does occur, monopolar RF resolves it within hours.

Source: Seo SB, Wan J, Yi KH. Energy-Based Device Management of Nodular Reaction Following PDLLA Injection for Tear Trough Rejuvenation. J Cosmet Dermatol 2025;24:e16575.

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PART 06 · CASE 01 Tear trough nodule — non-inflammatory FA

VAIM | Juvelook Safety Guideline

PATIENT

45 y/o female · no history of allergy/immune disease · PDLLA injected at mandibular border + cheek for skin laxity · onset 4 months post-injection

PRESENTATION & DIAGNOSIS

Presentation: Facial edema with granuloma-like reactions across all PDLLA injection areas (bilateral mandibular border + cheek). Patient reported discomfort and aesthetic concern.

Diagnosis: Granulomatous reaction (typical 6-24 mo window; this case at 4 mo on the early end). Ultrasound: multiple nodules in injection areas. No infection signs.

CLINICAL ILLUSTRATIONS

BEFORE

AFTER

TREATMENT PROTOCOL

1

Intralesional Triamcinolone

Injected into each granulomatous area

Every 2 weeks · total 4 sessions

(~8 weeks of intralesional therapy)

2

Concurrent oral Prednisone

20 mg/day × 3 days

then 10 mg/day × 2 days

(short taper to support intralesional effect)

3

Reassess at session 4

Clinical exam + ultrasound

Confirm resolution

No further intervention if resolved

OUTCOME Complete resolution of edema and granulomas after 4 applications (~8 weeks total).

KEY TAKEAWAY Granulomas respond well to intralesional steroids — 4 sessions are typically sufficient. The short oral prednisone taper supports intralesional therapy without requiring prolonged systemic immunosuppression.

Source: Perez Willis KM, Ramirez GR. Granuloma after the Injection of PDLLA Treated with Triamcinolone. Case Rep Dermatol Med 2024:6544506.

52

PART 06 · CASE 02 Mandibular granuloma — late-onset, steroid-responsive

VAIM | Juvelook Safety Guideline

PATIENT

53 y/o female · inflammatory nodules after PDLLA · ANA positive (1:160) · elevated TPO antibody · uncontrolled hypothyroidism · not a typical FBG

— autoimmune-driven Delayed Inflammatory Nodule

PRESENTATION & DIAGNOSIS

Presentation: Multiple inflammatory nodules at injection sites. Ultrasound: hypoechoic nodules with mild Doppler activity. Phlogistic signs present (warmth, redness). Laboratory revealed underlying autoimmune background.

Diagnosis: Autoimmune-background DIN (Delayed Inflammatory Nodule). Differs from typical FBG: underlying immune dysregulation amplifies and perpetuates inflammation. Requires modified protocol, not standard granuloma treatment.

CLINICAL ILLUSTRATIONS

BEFORE

AFTER

TREATMENT PROTOCOL

1

Low-dose intralesional steroid

Triamcinolone 2.5 mg/mL

Micro-depot 0.05–0.1 mL per point

Every 2 weeks

(lower than standard granuloma dose)

2

Saline injection on alt weeks

0.5–1.0 mL per nodule

Hydro-dilution between steroid sessions

(reduces particle density without

over-dosing steroid)

3

PAUSE heat/RF/massage

Stop energy-based devices

4–6 weeks during active inflammation

(heat exacerbates autoimmune cytokine

cascade in this patient class)

4

Endocrinology referral

Thyroid panel + ANA monitoring

Stabilize underlying autoimmune

disease (hypothyroidism control)

Consider Rinvoq® if refractory

OUTCOME Stabilized after 8–12 weeks; ultrasound-guided subcision planned after inflammation fully resolved.

KEY TAKEAWAY Autoimmune background changes everything. Always check ANA / thyroid panel in unexpectedly inflammatory PDLLA cases. Lower steroid dose, pause energy devices, treat the underlying autoimmune disease in parallel — not just the nodule.

Source: Dr. Seo’s clinical protocol — Ecuador case · modified intralesional protocol for autoimmune-prone patients.

53

PART 06 · CASE 03 Autoimmune-background DIN — modified protocol

VAIM | Juvelook Safety Guideline

PATIENT

Adult patient · temple region · asymptomatic visible hard subcutaneous nodule · onset 1 year after last PDLLA treatment · no phlogistic signs

PRESENTATION & DIAGNOSIS

Presentation: Asymptomatic but visible and palpable hard subcutaneous nodule at the temple. No warmth, no redness, no tenderness. Patient cosmetically concerned. Time of onset (1 year) places this in the late delayed category.

Diagnosis: Late-onset subcutaneous nodule. Long latency (>1 year) suggests slow inflammatory + low-grade biofilm contribution. Differential includes late hypersensitivity. Protocol covers both inflammatory + biofilm mechanisms.

CLINICAL ILLUSTRATIONS

BEFORE

AFTER

TREATMENT PROTOCOL

1

Oral corticosteroid

Initial 14-day course

(suppresses systemic inflammation

and prepares tissue for

intralesional therapy)

2

Doxycycline

21-day course

(broad anti-inflammatory + biofilm

coverage; doxycycline penetrates

biofilm matrix well)

3

Intralesional Betamethasone

Every 2 weeks · 10 sessions total

≈ 5 months of intralesional therapy

(sustained delivery into the

nodule itself)

4

Reassess at each session

Clinical exam at every visit

Continue until full subsidence

Patience is part of the protocol —

typical 10-session window

OUTCOME Nodule subsided over the 10-session course

(~5 months total treatment duration).

KEY TAKEAWAY Late-onset nodules (>1 year) require sustained intralesional therapy — 10 sessions is normal, not a treatment failure. Add doxycycline for potential biofilm coverage. Communicate timeline expectations to the patient from session 1: this is the multi-session reality of PDLLA AE management.

Source: Dr. Seo’s clinical case — late-onset temple nodule protocol with adjunctive doxycycline coverage.

54

PART 06 · CASE 04 Late-onset temple nodule — multi-session reality

VAIM | Juvelook Safety Guideline

PATIENT

38 y/o female · multiple smooth-surfaced facial papules (3–5 mm) · filler-related FBG (published case used PDRN-composite filler — included as evidence-based reference for refractory PDLLA-induced FBG, where same JAK inhibitor protocol applies) · failed initial steroid course

PRESENTATION & DIAGNOSIS

Presentation: Multiple erythematous papules and pruritus across the face. Symptoms developed 24 h after injection and persisted for 1 week before presentation. Failed standard treatment.

Diagnosis: Refractory foreign body granuloma. Initial therapy failed: oral prednisolone 15 mg twice daily × 3 d + intramuscular dexamethasone 5 mg/d × 3 d + topical metronidazole / mometasone / hydrocortisone.

CLINICAL ILLUSTRATIONS

BEFORE

AFTER

TREATMENT PROTOCOL

1

Step-up to JAK inhibitor

Oral Abrocitinib 100 mg daily

(JAK1 inhibitor — blocks STAT-mediated

granulomatous inflammation)

2

Concurrent Prednisone

30 mg daily, tapered over 9 weeks

(reduces acute inflammation while

JAK inhibitor takes effect)

3

Weekly monitoring

Clinical photography

Dermoscopy + reflectance confocal microscopy

Monitor for adverse effects

OUTCOME Complete granuloma resolution by week 13. No treatment-related adverse effects at 1-month follow-up.

KEY TAKEAWAY When standard granuloma protocol (Case 2) fails, JAK inhibitor escalation (Abrocitinib or Upadacitinib / Rinvoq®) + concurrent prednisone is an evidence-based step-up. 13 weeks of patience — but resolution is achievable without surgery.

Source: Fu et al. Successful Treatment of Cutaneous Foreign Body Granuloma with JAK Inhibitor Abrocitinib and Prednisone. Clin Cosmet Investig Dermatol 2025;18:1199–1206.

55

Note: This case does not represent a PDLLA-related adverse event. It was included solely as a reference case to illustrate the use of a JAK inhibitor for granuloma management.

PART 06 · CASE 05 Refractory granuloma — JAK inhibitor escalation

VAIM | Juvelook Safety Guideline

What unites these five cases — and what they teach us about Juvelook safety management.

1

PDLLA is soft — and so are its adverse events.

Across all 5 cases, no surgical excision was required. PDLLA's amorphous, low-Tg structure means that even when adverse events occur, the material remains responsive to mechanical, thermal, and pharmacological intervention. This is structurally different from harder, semi-crystalline biostimulators.

2

Diagnosis dictates protocol — one size does NOT fit all.

Case 1 (non-inflammatory FA) needed energy-based device, not steroids. Case 2 (granuloma) needed steroids. Case 3 (autoimmune) needed lower-dose modified protocol. Case 4 (late-onset) needed antibiotic coverage. Case 5 (refractory) needed JAK inhibitor. Always confirm category before treating.

3

Always check for autoimmune background in inflammatory cases.

Case 3 — unexpectedly inflammatory PDLLA nodule turned out to be driven by underlying autoimmune disease (ANA+, thyroid dysfunction). Run ANA / thyroid panel when inflammation is disproportionate. Modify protocol: lower steroid dose, pause energy devices, treat the autoimmune cause in parallel.

4

Patience is part of the protocol — not a treatment failure.

Cases 2, 4, and 5 required 4 sessions, 10 sessions, and 13 weeks respectively. Case 1 took 24 hours; Case 3 took several months for stabilization. The number of sessions is not a measure of treatment failure — it is the realistic timeline for PDLLA AE resolution. Communicate this to patients from session 1.

5

When standard protocol fails, evidence-based escalation works.

Case 5 demonstrates that refractory cases are not dead ends. JAK inhibitors (Abrocitinib, Upadacitinib / Rinvoq®) + corticosteroid are an evidence-based step-up. Surgical excision is the absolute last resort — not the next step after first-line failure.

Source: Synthesis from all 5 cases — Seo 2025 · Perez Willis 2024 · Dr. Seo’s Case · Fu et al. 2025.

56

PART 06 · LESSONS Cross-case Lessons — what these five cases tell us

VAIM | Juvelook Safety Guideline

PART 07

07

Patient Education & Consent

Patient communication is not a single conversation — it is four distinct phases, each with its own skills and stakes. Done well, communication prevents most complaints, supports recovery when adverse events occur, and protects both the patient and the practitioner.

1

PRE-PROCEDURE

EDUCATION

Before treatment

Set realistic expectations.

Explain mechanism.

Discuss possible AEs honestly

(low probability + manageable).

Build trust before the needle.

2

INFORMED

CONSENT

Documentation

Six essential elements.

Material risks disclosed.

Photographic consent.

Duty of Candour.

Document everything.

3

POST-PROCEDURE

CARE

Daily routine

Aftercare instructions.

Normal vs. concerning signs.

Follow-up schedule.

Communication channels.

When to call us.

4

AE

COMMUNICATION

When complications occur

SPIKES protocol.

Reassurance done right.

Multi-session reality.

Lead the patient through.

Resist the urge to explain first.

Core principle: Probabilities of nodule or granuloma are low — but when they do occur, patients become worried and sometimes angry. The clinician's job is to communicate clearly that PDLLA-related adverse events are manageable without surgery, given time and patience.

Source: Composite framework — Pincus T 2017 · Baile et al. 2000 · Birks 2014 Duty of Candour · ACOG disclosure guideline.

58

PART 07 Four Phases of Patient Communication

VAIM | Juvelook Safety Guideline

Pincus et al. 2017 (PMC5537438) found that empathy alone does not reduce patient concern — structured information delivery does. Set expectations honestly before treatment using the Two Truths approach.

TRUTH 1

Adverse events are uncommon.

Cite the numbers honestly:

• Juvelook AE rate ≈ 0.0075% · nodule rate ≈ 0.0029%

• Juvelook Volume AE rate ≈ 0.021% · nodule rate ≈ 0.016%

Lower than most comparator biostimulators — driven by PDLLA's amorphous, soft particle structure.

TRUTH 2

When AEs do occur, they are manageable.

Be honest about both halves:

• No surgery required for the vast majority of cases.

• Most resolve in days to weeks (massage, RF, intralesional therapy).

• Some need patience — 4–10+ sessions over several months in rare cases.

Telling them now protects the relationship later — if it happens, it will not feel like a betrayal.

PINCUS REASSURANCE INSIGHT · Best Practice Research Clinical Rheumatology 2017

Reassurance has two components — and the order matters.

1. Affective reassurance (empathy, listening, validating concern). Required first. Patients who feel unheard reject the information that follows.

2. Cognitive reassurance (facts, evidence, statistics, treatment options). Only after empathy is established. Delivered too early, it sounds dismissive — 'don't worry, it's rare' — and increases anxiety.

Source: Pincus T, Holt N, Vogel S, Underwood M. Reassurance for non-specific conditions: a user's guide. Best Pract Res Clin Rheumatol 2017 (PMC5537438).

59

PART 07 · PHASE 1 Pre-procedure Education — the Two Truths framework

VAIM | Juvelook Safety Guideline

A signed consent form is not the same as informed consent. Informed consent is the documented evidence of a structured conversation. The six elements below — discussed and documented — are the minimum.

1

Diagnosis / Indication

Why treatment is appropriate for this patient. The aesthetic concern + clinical reasoning.

2

Nature of the Procedure

Product (Juvelook / Juvelook Volume), depth of injection, anatomic regions, technique.

3

Material Risks

Vascular events (rare); nodules / granulomas (uncommon); ecchymosis, edema; allergic reactions.

4

Reasonable Alternatives

Other biostimulators (PLA, CaHA); HA fillers; energy-based devices; no treatment.

5

Expected Benefits

Gradual collagen induction; 3–6 months for full effect; duration of result (typical 12–18 months).

6

Consequences of No Treatment

Continued aesthetic concern; natural age-related volume / texture changes.

ADDITIONAL DOCUMENTATION

• Photographic consent (pre-treatment baseline + follow-up).

• Local regulatory compliance — verify approved indications and any additional consent requirements per your jurisdiction (varies by country and product registration).

• Cost & financial agreement (including potential follow-up sessions for AE management — discuss policy upfront).

• Patient questions documented (what they asked + how you answered).

• Waiting period where required (jurisdiction-dependent).

DUTY OF CANDOUR · Birks 2014, Clinical Risk

If an adverse event occurs, you have a legal and ethical obligation to disclose it honestly — even if the patient does not ask, and even if the AE is mild.

What to disclose:

• What happened (factual, no speculation).

• Why it likely happened (mechanism, when known).

• What the treatment plan is.

• What follow-up looks like.

Apologize meaningfully — apology is not admission of negligence and is protected in most jurisdictions.

Source: Six elements per ACOG informed consent framework · Birks Y. Duty of Candour. Clinical Risk 2014.

60

PART 07 · PHASE 2 Informed Consent — six elements + Duty of Candour

VAIM | Juvelook Safety Guideline

Give written aftercare instructions at the end of every appointment. The first 24 hours and the first week shape the patient's perception of the procedure — and their willingness to return.

FIRST 24 HOURS

0-24h

• Cold compress 15 min on / 15 min off for first 2-4 hours

• Avoid touching, rubbing, or applying pressure

• Sleep elevated (extra pillow) if facial treatment

• Mild swelling, redness, bruising are normal

• Mild discomfort manageable with paracetamol

DAYS 1–7

1-7d

• Avoid intense exercise, sauna, hot yoga

• Avoid alcohol for first 48 hours

• Avoid direct sun exposure; use SPF 30+

• Gentle facial cleansing only

• Continue normal makeup after 24 hours

WEEKS 1–4

1-4wk

• Swelling and bruising fully resolve

• Minimal visible change yet — this is normal

• Collagen induction is gradual

• Avoid facial dermal procedures during this window

• Schedule follow-up assessment

MONTHS 1–6

1-6mo

• Gradual visible result emerges

• Full effect typically by month 3-6

• Touch-up sessions may be planned

• Maintenance schedule discussed

• Document outcome with photography

WHEN TO CALL US IMMEDIATELY · Patient-facing message

Most reactions resolve on their own. Contact us right away if you experience:

• Severe or worsening pain, especially out of proportion to the procedure (vascular concern)

• Skin color changes (white, blue, or dusky discoloration) (vascular concern)

• Vision changes (any) — go to ER immediately, then call us (critical vascular event)

• Spreading redness or warmth beyond 48 hours (possible infection)

• New lumps that persist beyond 2 weeks or any later-onset firm areas (possible nodule — early intervention is easier)

Source: Standard post-procedure aftercare adapted for PDLLA-HA biostimulators · see Part 04 for AE diagnostic framework.

61

PART 07 · PHASE 3 Post-procedure Care — what to tell every patient

VAIM | Juvelook Safety Guideline

The SPIKES protocol (Baile et al., Oncologist 2000) is the most widely-validated framework for delivering difficult medical news. Adapted for cosmetic adverse events, it gives a six-step structure that resists the natural urge to begin with explanation — and reduces patient distress, complaint, and litigation risk.

S

SETTING

Set up the conversation

Private space. Sit down — do not stand. Eye level with patient. Have their record + photos in front of you. Allow 15+ uninterrupted minutes.

P

PERCEPTION

Ask before telling

Begin with: "Tell me what you're noticing." Find out what the patient already believes is happening before you explain anything.

I

INVITATION

Ask permission to share

"Would you like me to walk you through what I think is going on?" Patients vary in how much detail they want — calibrate to the individual.

K

KNOWLEDGE

Give information in small chunks

Short sentences. Plain language — avoid jargon. Pause every 2–3 sentences. Confirm understanding before moving on. Avoid the urge to over-explain.

E

EMOTIONS

Empathize first — facts later

"This is understandably upsetting." Name the emotion. Validate the concern. Do not jump to reassurance until the patient has been heard.

S

STRATEGY

Lay out the plan together

Concrete next steps. Timeline expectations (this is where the multi-session reality comes in). When the next visit is. How to reach you between visits.

Core principle: Empathy first. Information second. Plan third. Reversing this order — starting with the medical explanation — is the single most common communication mistake.

Source: Baile WF, Buckman R, Lenzi R, Glober G, Beale EA, Kudelka AP. SPIKES — a six-step protocol for delivering bad news. Oncologist 2000;5:302–311.

62

PART 07 · PHASE 4 When an Adverse Event Occurs — the SPIKES Protocol

VAIM | Juvelook Safety Guideline

Part 06 showed five cases — resolution timelines ranged from 24 hours to 13 weeks. Most cases land in the 4–10+ session range over several months. The clinician's job is not just to treat — it is to lead the patient through, session by session, until resolution.

1

Set timeline expectations from session 1.

When you confirm an AE diagnosis, give the timeline upfront. "This will likely take 4 to 10 sessions over several months." Patients who hear this at the start treat each subsequent visit as part of the plan, not as a failure of the previous one.

2

Photograph at every visit.

Even when the patient does not see change, the photograph does. Compare today's photo to the photo two sessions ago. Visual evidence of progress is the strongest reassurance — much more durable than verbal reassurance.

3

Schedule the next visit before they leave.

Never let a patient leave with an open follow-up. Book the next session, confirm it, write the date on a card. An open follow-up is when patients seek opinions elsewhere — and that is when the relationship is lost.

4

Provide a communication channel between visits.

Give the patient a way to reach you (clinic number, dedicated email, secure messaging) and clearly define what "normal between-visit" looks like. Patients who know they can reach you call less, not more — and they call about the right things.

5

Re-state the core message at every visit.

"This is going as expected. PDLLA adverse events are manageable without surgery. The treatments we are doing work — they just take time." Say it every visit. Patients forget. Repetition is the work of reassurance.

Source: Synthesis — Pincus 2017 reassurance principles · multi-session protocols from Part 06 (Cases 2–5) · clinical experience.

63

PART 07 · PHASE 4 (cont.) Leading Patients Through — the multi-session reality

VAIM | Juvelook Safety Guideline

Real questions you will hear — and sample responses you can adapt to your own voice. Each follows the SPIKES order: validate the emotion first, give the information second, end with a plan.

PATIENT:

"Did something go wrong?"

SAMPLE RESPONSE:

"I understand why you're worried. What you're experiencing is a known adverse event — uncommon, but documented. Let me explain what we're seeing and what we're going to do about it."

PATIENT:

"Will I need surgery?"

SAMPLE RESPONSE:

"This kind of nodule does not require surgery in the vast majority of cases. Surgery is the absolute last resort, and we have several effective non-surgical options before we'd even consider it."

PATIENT:

"How long until this is fixed?"

SAMPLE RESPONSE:

"Honest answer: this typically takes 4 to 10 sessions over a few months. I want you to know that timeline now, so each visit feels like part of the plan — not a failure of the last one."

PATIENT:

"Why didn't you tell me this could happen?"

SAMPLE RESPONSE:

"That's a fair question. We did discuss this as a possible adverse event during consent, and I have the documentation. But I understand it didn't feel real then. It is now — let's talk about it."

PATIENT:

"Should I see a specialist?"

SAMPLE RESPONSE:

"I am the specialist for this kind of complication, and the treatment we're starting is the evidence-based first-line. If at any point we're not seeing the response we expect, we'll discuss escalation options together."

PATIENT:

"What's the worst-case scenario?"

SAMPLE RESPONSE:

"In the worst case, this takes longer than we hope and requires more sessions or escalation to systemic therapy. I want to be honest about that. But across the cases I'm familiar with, resolution without surgery is the rule, not the exception."

End of Guide. Treatment is half the work. Communication — done well, with empathy first and structure second — is the other half.

Source: Sample scripts derived from SPIKES (Baile 2000) sequence applied to PDLLA-specific AE patterns from Part 06.

64

PART 07 · REFERENCE Communication Scripts — what to say when patients ask

VAIM | Juvelook Safety Guideline

The practitioner is prepared.

And the patient is safer because of it.

Juvelook is soft.

Adverse events are soft.

Resolution is non-surgical.

Patience, when needed, pays off.

VAIM Medical Affairs · official@vaim.co.kr

Juvelook® Safety Guideline · 2026 · © VAIM Co., Ltd. All rights reserved.