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

Laboratoires Genévrier

Status

Completed

Conditions

Aesthetics

Treatments

Device: Hyaluronic acid dermal filler with lidocaine 0.3%

Study type

Interventional

Funder types

Industry

Identifiers

NCT02703740

15F/IALE01

Details and patient eligibility

About

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).

Full 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

Enrollment

60 patients

Sex

All

Ages

19+ years old

Volunteers

Accepts Healthy Volunteers

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.