NCT03127384已完成4 期
A Randomised, Evaluator-blind Comparative Study to Evaluate Performance and Safety of Restylane Lidocaine and No-treatment Control for Treatment of Depressed Facial Acne Scars
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Percentage of Participants With Lower Scar Severity in the Treated Cheek Compared to the Untreated Cheek
研究概览
简要总结
The purpose of this study is to evaluate performance and safety of Restylane Lidocaine for treatment of depressed facial acne scars
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Intent to undergo treatment of depressed acne scars
- •Presence of 5-20 scars with a diameter of up to approximately 4 mm within the treatment area
- •Similar type, size and number of scars on both cheeks
- •Men or non-pregnant, non-breast feeding women
- •Fitzpatrick skin type I-IV
- •Signed and dated informed consent to participate in the study
排除标准
- •Presence of more than 3 scars per cheek (within the treatment area) of the following types: icepick scars or atrophic acne scars with a diameter of > 4 mm.
- •Active acne with inflammatory component
- •Use of per oral or topical (facial) substances containing retinoids, bensoyl peroxide, alpha-hydroxy acid at concentrations above 10%, beta-hydroxy acid at a concentration above 2%, or antibiotic treatment for active acne within 4 months before treatment
- •Use of isotretinoin within 6 months before treatment
- •Post-surgical scars in the treatment area
- •Previous tissue augmenting therapy or contouring with permanent filler or fat-injection in the treatment area
- •Previous tissue augmenting therapy, contouring or revitalisation treatment with Calcium Hydroxyapatite (CaHa), or Poly L-Lactic Acid (PLLA), in the treatment area within 24 months before treatment
- •Previous tissue augmenting therapy, contouring or revitalisation treatment with non-permanent filler such as hyaluronic acid (HA) or collagen in the treatment area within 12 months before treatment
- •Previous tissue revitalisation treatment with neurotoxin, laser or light, mesotherapy, chemical peeling or dermabrasion in the treatment area within 6 months before treatment
- •Previous surgery including aesthetic facial surgical therapy, liposuction, or tattoo in the treatment area
- •Any medical condition that, in the opinion of the treating Investigator, would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may interfere with the outcome of the study)
结局指标
主要结局
Percentage of Participants With Lower Scar Severity in the Treated Cheek Compared to the Untreated Cheek
时间窗: Month 3
Overall scar severity assessed by blinded evaluator.
次要结局
- Percentage of Participants Improved on the Global Aesthetic Improvement Scale (GAIS)(Month 1, Month 3)
研究者
研究点 (2)
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