Long Term Safety and Efficacy Assessment of Hyaluronic Acid Dermal Filler With for the Treatment of Nasolabial Folds
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Number and description of adverse events that are related to treatment
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
HA 20 mg/mL
Intervention: Hyaluronic acid dermal filler with lidocaine 0.3% (Device)
HA 24 mg/mL
Intervention: Hyaluronic acid dermal filler with lidocaine 0.3% (Device)
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(72h/3 months/6 Months/9 months/12 months)
- Treatment efficacy assessed by WSRS(1/3/6/9/12 months)