Evaluation of the Risk of Atrophic Acne Scar Formation During Treatment of Acne Vulgaris Subjects With Trifarotene 50 μg/g Cream Versus Vehicle Cream Over 24 Weeks
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 121
- 试验地点
- 18
- 主要终点
- Absolute Change From Baseline in Total Atrophic Acne Scar Count Per Half Face at Week 24
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of trifarotene 50 microgram per gram (mcg/g) cream compared to its vehicle on the risk of formation of atrophic acne scars after 24 weeks of treatment in facial acne participants assessed by atrophic acne scars count.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 17 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant with clinical diagnosis of acne vulgaris on the face as defined by (excluding the nose and middle zone of approximately 2 centimeter [cm]):
- •Investigator's Global Assessment (IGA) score of 3 (Moderate) or 4 (Severe), with the same score on both sides of the face; and
- •A minimum of 20 inflammatory lesions (papules and pustules) in total with at least 10 on each side; and
- •No more than 2 nodules (greater than or equal to [>=] 1 cm in diameter) on the face; and
- •A minimum of 10 atrophic acne scars in total (>2 mm)
- •Participant with a symmetrical number of the following lesions/scars on the whole face:
- •Inflammatory and non-inflammatory lesions; and
- •Atrophic acne scars (minimum of 4 scars per half-face)
- •The participant is a female of non-childbearing potential
- •If a female of childbearing, potential uses oral contraceptives that are also approve for treating acne vulgaris
- •Other protocol defined inclusion criteria could apply
排除标准
- •Participant with acne conglobata, acne fulminans, secondary acne, nodulocystic acne and acne requiring systemic treatment
- •Participant with any acne cyst on the face or with more than 3 excoriated acne lesions
- •Participant with known active or chronic allergies or suspected allergy to trifarotene or excipients of the formulation
- •Participant with facial dermal conditions (for example, tattoo, skin abrasion, eczema, sunburned skin, scars, nevi, etc.) that may interfere with study assessments in the opinion of the investigator
- •Participant with known impaired hepatic or renal functions, based on medical history
研究组 & 干预措施
Trifarotene Vehicle Cream
干预措施: Trifarotene Vehicle Cream (Drug)
Trifarotene (CD5789) 50 mcg/g Cream
干预措施: Trifarotene Cream (Drug)
结局指标
主要结局
Absolute Change From Baseline in Total Atrophic Acne Scar Count Per Half Face at Week 24
时间窗: Baseline, Week 24
The scars were counted according to their size defined in two categories using 2 millimeter (mm) and 4 mm punch biopsy tools for size classification: 1) atrophic scars 2 to 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types; 2) atrophic scars greater than (\>) 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types. Each type of atrophic acne scar was counted separately for each half-face by the evaluator for following regions: right forehead, right cheek, right side of the chin, left forehead, left cheek and left side of the chin. To obtain the total number of atrophic scars per half-face, atrophic acne scar counts for each half-face was added.
次要结局
- Absolute Change From Baseline in Total Atrophic Acne Scar Count Per Half-Face up to Week 20(Baseline, up to Week 20)