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

Not Applicable

Completed

• Conditions: Aesthetics
• Interventions: Device: Hyaluronic acid dermal filler with lidocaine 0.3%

• Registration Number: NCT02703740
• Lead Sponsor: Laboratoires Genévrier

Brief Summary

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

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 Timeline

• Study Start: 2016-01-11
• Study First Submitted: 2016-01-18
• Study First Submitted QC: 2016-03-03
• Study First Posted: 2016-03-09
• Primary Completion: 2017-02-03
• Study Completion: 2017-02-03
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-10
• Last Update Posted: 2019-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HA 20 mg/mL	Hyaluronic acid dermal filler with lidocaine 0.3%	-
HA 24 mg/mL	Hyaluronic acid dermal filler with lidocaine 0.3%	-

Primary Outcome Measures

Name	Time	Method
Number and description of adverse events that are related to treatment	1 month

Secondary Outcome Measures

Name	Time	Method
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	1/3/6/9/12 months	WSRS (wrinkle severity rating scale) : a 5-point validated scale ranging from 1 (absent) to 5 (extreme).

Trial Locations

Locations (1)

CREABIO; 🇫🇷 Lyon, France