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

Laboratoires Genévrier60 enrolled

Overview

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).

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Aesthetics

Interventions

Hyaluronic acid dermal filler with lidocaine 0.3%DEVICE

injection in labial fold of a dermal filler

Eligibility

Sex: ALLMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

CREABIO

Lyon, France

Outcomes

Primary Outcomes

Number and description of adverse events that are related to treatment

Time frame: 1 month

Secondary Outcomes

Number and description of adverse events that are related to treatment

Time frame: 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).

Time frame: 1/3/6/9/12 months

Data from ClinicalTrials.gov

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