The purpose of this study is to assess the effectiveness and safety of Gana V, a Poly L-lactic acid filler for the aesthetic treatment of nasolabial folds, in comparison with Sculptra.
A screening visit will allow to inform and preselect the participants. On D0, baseline scoring, fringe projection acquisitions and photographs will be done before injection. Eligible participants will receive a first injection of the two products according to the randomization list. Immediately after injection, injector's treatment satisfaction will be collected. Investigator evaluator will collect Adverse Events (AEs) and Injection Site Reactions (ISRs) immediately after injection. A month and a half after initial injection (M11/2), clinical scoring, fringe projection acquisitions and photographs will be done before touch-up (if applicable). Participant's treatment satisfaction and injector's treatment satisfaction (if applicable) will be collected. A touch-up injection will be made if necessary, according to injector and participant opinion. Investigator evaluator will collect AEs and ISRs before and after touch-up if applicable. Three (M3), six (M6), nine (M9), twelve (M12), eighteen (M18) and twenty-four (M24) months after initial injection, clinical scoring, fringe projection acquisitions and photographs will be done. Participant's treatment satisfaction will be collected. Investigator evaluator will collect AEs and ISRs
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
59
Injection in the deep dermis and subcutaneous layer of the nasolabial fold on D0 (initial injection) and 1 month and a half after initial injection if necessary (optional touch-up).
Injection in the deep dermis and subcutaneous layer of the nasolabial fold on D0 (initial injection) and 1 month and a half after initial injection if necessary (optional touch-up).
Eurofins Dermscan Pharmascan
Villeurbanne, France
Change From Baseline in the Nasolabial Folds Severity Score on the Wrinkle Severity Rating Scale (WSRS) 6 Months After Treatment
The Wrinkle Severity Rating Scale is a scale for measurement of the nasolabial folds wrinkles severity. The scale ranges from Grade 1 (absent-better outcome) to Grade 5 (extreme-worse outcome) Change of grades was calculated as the value at 6 months minus the value at baseline. To observe an improvement of the nasolabial folds wrinkles, a decrease of the mean score was expected.
Time frame: Baseline and Month 6
Change From Baseline in the Nasolabial Folds Severity Score on the Wrinkle Severity Rating Scale (WSRS)
The Wrinkle Severity Rating Scale is a scale for measurement of the nasolabial folds wrinkles severity. The scale ranges from Grade 1 (absent-better outcome) to Grade 5 (extreme-worse outcome) Change of grades was calculated as the value at month X minus the value at baseline. To observe an improvement of the nasolabial folds wrinkles, a decrease of the mean score was expected.
Time frame: Baseline, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24
WSRS Responders Rate
The Wrinkle Severity Rating Scale is a scale for measurement of the nasolabial folds wrinkles severity. The scale ranges from Grade 1 (absent-better outcome) to Grade 5 (extreme-worse outcome) Responders rate = percentage of participants with an improvement of at least one grade in WSRS compared to baseline score. An improvement represents a decrease in WSRS (from grade 5 to grade 4 for instance)
Time frame: Baseline, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Percentage of participants with an improvement on GAIS. A responder is defined as a subject having "Improved", "Much improved" or "Very much improved" score according to GAIS.
Time frame: Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24
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Change From Baseline in Nasolabial Folds Average Depth (mm)
The average depth of the nasolabial folds wrinkles was calculated using a fringe projection system. An increase of the mean value means a positive outcome. Change was calculated as the value at each follow-up visit minus the value at baseline
Time frame: Baseline, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24
Change From Baseline in Nasolabial Folds Volume
The volume of the nasolabial folds wrinkles was calculated using a fringe projection system. A decrease of the volume means a positive outcome.
Time frame: Baseline, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24
Proportion of Satisfied Participants
Percentage of participants with positive answers to an internal questionnaire
Time frame: Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24
Injector Satisfaction
Percentage of participants
Time frame: After initial injection (Day 0) and touch-up if applicable (Month 1^1/2)
Collection of Injection Site Reactions
Proportion of subjects presenting at least one ISR of any severity
Time frame: Day 0, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24
Collection of Adverse Events
Number of Adverse Events (AEs) Number of Adverse Device Effects (ADEs) Proportion of subjects with at least one AE Proportion of subject with at least one ADE
Time frame: Day 0 to Month 24