Clinical Study for the Evaluation of the Safety and Effectiveness of Use of a Poly-L Lactic Acid Injectable Filler for the Aesthetic Treatment of Nasolabial Folds

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Clinical Study for the Safety and Effectiveness of Use of an Injectable Medical Device GANA V® for Facial Aesthetic Treatment

Conditions
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Wrinkle

Intervention / Treatment
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* Device: Gana V®
* Device: Sculptra®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject with moderate to severe nasolabial folds as determined by a Wrinkle Severity Rating Scale (WSRS) score of 3 or 4 on both folds at the pre-treatment evaluation. Subject wiling to abstain from other facial procedures (i.e., dermal fillers, toxin treatments, laser, microdermal abrasion, chemical peels, non-invasive skin-tightening) during the whole study period. Subject, psychologically able to understand the study related information and to give a written informed consent. Subject having given freely and expressly his/her informed consent. Subject willing to have photographs of the face taken. Subject affiliated to a health social security system. Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 12 weeks before screening visit and during the whole study period. Exclusion Criteria: Pregnant or nursing woman or planning a pregnancy during the study. Subject with a scar, moles, pigment disorders or anything on the face which might interfere with the evaluation. Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship. Subject in a social or sanitary establishment Subject participation to another research on human beings or who is in an exclusion period of one. Subject having received 4500 euros indemnities for participation in research involving human beings in the 12 previous months, including participation in the present study. Subject suspected to be non-compliant according to the investigator's judgment. Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results. Subject with known history of or suffering from autoimmune disease and/or immune deficiency. Subject suffering from inflammatory and/or infectious cutaneous disorders in or near the studied zones (e.g. acne, mycosis, papilloma, chronic eczema, atopic dermatitis…). Subject with labial herpes in the last 2 years is not eligible even if asymptomatic at time of screening visit. Subject with an abscess, unhealed wound, or a cancerous or precancerous lesion on the studied zone. Subject prone to develop inflammatory skin conditions or having tendency to bleeding disorders. Subject with a tendency to develop keloids or hypertrophic scarring. Subject having history of allergy or anaphylactic shock including hypersensitivity to Poly-l-lactic acid, to lidocaine or to one of the components of the tested devices or antiseptic solution. Subject having received treatment with a laser, a dermabrasion, a surgery, a deep chemical peeling or other ablative procedure on the face within the past 12 months prior to screening visit. Subject having received injection with a resorbable filling product in the face area within the past 12 months prior to screening visit. Subject having received at any time injection with a slowly resorbable filling product (polylactic acid, calcium hydroxyapatite, combinations of hyaluronic acid (HA) and hypromellose, HA and dextran microbeads or HA and TriCalcium Phosphate (TCP), …) or with a non-resorbable filling product (polyacrylamide, silicone, combination of methacrylic polymers and collagen, polymer particles, …) on the face. Subject having received at any time a treatment with tensor threads on the face. Subject having started or changed her oral contraceptive or any other hormonal treatment during 12 weeks prior to screening visit. Subject using medication such as aspirin, nonsteroidal anti-inflammatory drugs (NSAID) (ibuprofen, naproxen, …), antiplatelet agents, anticoagulants or other substances known to prolong bleeding time within 1 week prior to injection visits. Subject undergoing a topical treatment on the test area or a systemic treatment: Antihistamines during the 2 weeks prior to screening visit. Immunosuppressors and/or corticoids during the 4 weeks prior to screening visit. Retinoids during the 6 months prior to screening visit. Intensive exposure to sunlight or UV-rays within the previous month before and after injection visits.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All participants will receive both fillers
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gana V versus Sculptra<br>Participants will receive both Gana V and Sculptra: one in each nasolabial folds | Device: Gana V®<br>* 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).<br>Device: Sculptra®<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the nasolabial folds severity score on the Wrinkle Severity Rating Scale (WSRS) 6 months after treatment | The WSRS is a validated scale for the evaluation of nasolabial folds severity. Possible scores range from 1 (absent) to 5 (extremely). This score will be assessed by a blinded evaluator in live. | Baseline and Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the nasolabial folds severity score on the Wrinkle Severity Rating Scale (WSRS) | The WSRS is a validated scale for the evaluation of nasolabial folds severity. Possible scores range from 1 (absent) to 5 (extremely). This score will be assessed by a blinded evaluator in live. | Baseline, Month 1^1/2, Month 3, Month 9, Month 12, Month 18 and Month 24 | 
| WSRS responders rate | The WSRS is a validated scale for the evaluation of nasolabial folds severity. Possible scores range from 1 (absent) to 5 (extremely). A responder is defined as a subject with at least 1-point improvement from baseline on the WSRS. This score will be assessed by a blinded evaluator in live. | 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 | The GAIS is a validated scale for the evaluation of aesthetic improvement. Possible scores range from 1 (very much improved) to 5 (worse). A responder is defined as a subject having Improved, Much improved or Very much improved score according to GAIS. This score will be assessed by a blinded evaluator in live and by the participants. | Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24 | 
| Change from baseline in nasolabial folds depth | This will be assessed using 3D acquisitions of the face | 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 | This will be assessed using 3D acquisitions of the face | Baseline, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24 | 
| Proportion of satisfied participants | With a questionnaire | Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24 | 
| Injector satisfaction | The investigator who will inject the products will complete a questionnaire for each participant. | After initial injection (Day 0) and touch-up if applicable (Month 1^1/2) | 
| Collection of injection site reactions | Collection by the participants until one month after injection and by the investigator at each visit | Day 0, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24 | 
| Collection of adverse events | Collection by the participants during the whole study period and by the investigator at each visit | Day 0 to Month 24 |