Clinical Study for the Safety and Effectiveness of Use of an Injectable Medical Device GANA V® for Facial Aesthetic Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- GCS Co., Ltd
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Change From Baseline in the Nasolabial Folds Severity Score on the Wrinkle Severity Rating Scale (WSRS) 6 Months After Treatment
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Participants and investigators assessors will not know which filler was used on each side of the face (hemi-face design)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change From Baseline in the Nasolabial Folds Severity Score on the Wrinkle Severity Rating Scale (WSRS) 6 Months After Treatment
时间窗: Baseline and Month 6
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.
次要结局
- Change From Baseline in the Nasolabial Folds Severity Score on the Wrinkle Severity Rating Scale (WSRS)(Baseline, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24)
- WSRS Responders Rate(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(Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24)
- Change From Baseline in Nasolabial Folds Average Depth (mm)(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(Baseline, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24)
- Proportion of Satisfied Participants(Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24)
- Injector Satisfaction(After initial injection (Day 0) and touch-up if applicable (Month 1^1/2))
- Collection of Injection Site Reactions(Day 0, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24)
- Collection of Adverse Events(Day 0 to Month 24)