Long Term Safety and Efficacy Assessment of Hyaluronic Acid Dermal Filler With for the Treatment of Nasolabial Folds

Study Overview
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Brief Summary
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This study evaluates the injection of a hyaluronic acid dermal filler with lidocaine 0.3% in the treatment of nasolabial folds (NLF). Each patient will receive 1 concentration in a NLF (20 mg/mL) and an other concentration in the other NLF (24 mg/mL).

Detailed Description
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Interventional, monocentric, double blind, randomised study Evaluation of safety the 1st month (primary criteria) and until 12 month Evaluation of performance at baseline, month 3, month 6, month 9 and month 12 : WSRS (wrinkle scale), profilometry (image measuring wrinkle depth and area), GAIS : satisfaction scale

Official Title
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Long Term Safety and Efficacy Assessment of Hyaluronic Acid Dermal Filler With for the Treatment of Nasolabial Folds

Conditions
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Aesthetics

Intervention / Treatment
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* Device: Hyaluronic acid dermal filler with lidocaine 0.3%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is at least 19 years of age. Has Fitzpatrick Skin Type IV, V, or VI. Has a WSRS score > or = to 3 for both NLF Understands and accepts the obligation not to receive any other procedures or treatments in the nasolabial fold for 6 months Exclusion Criteria: Has keloid formation, or hypertrophic scarring or dyschromic scaring. Has hypersensitivity to hyaluronic acid, Chlorhexidine lidocaine or local anaesthetic drugs Has a known bleeding disorder or is receiving drug therapy that could increase the risk of bleeding. Has nasolabial folds that are too severe to be corrected in one treatment session. Has received any dermal filler or other injections, grafting or surgery in either nasolabial fold during the last year. Is pregnant, lactating, or not using acceptable contraception.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HA 20 mg/mL<br> | Device: Hyaluronic acid dermal filler with lidocaine 0.3%<br>* injection in labial fold of a dermal filler<br>|
| Experimental: HA 24 mg/mL<br> | Device: Hyaluronic acid dermal filler with lidocaine 0.3%<br>* injection in labial fold of a dermal filler<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and description of adverse events that are related to treatment |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and description of adverse events that are related to treatment |  | 72h/3 months/6 Months/9 months/12 months | 
| Treatment efficacy assessed by WSRS | WSRS (wrinkle severity rating scale) : a 5-point validated scale ranging from 1 (absent) to 5 (extreme). | 1/3/6/9/12 months |