Aesthetics
Conditions
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
Interventions
DEVICEHyaluronic acid dermal filler with lidocaine 0.3%
injection in labial fold of a dermal filler
Sponsors
Laboratoires Genévrier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number and description of adverse events that are related to treatment | 1 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
France
Outcome results
None listed