Adjunctive Usage of a Moisturizing Lotion (Cetaphil® Moisturizing Lotion) to Limit the Skin Irritation Linked to the Set-up of a Treatment by Topical Retinoid (Differin® Gel 0,1%) in Healthy Subjects of Chinese Origins
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pruritus
研究概览
简要总结
This is a single-center study, randomized, Investigator/Evaluator-blinded bilateral (split-face) comparison.
The objective: To assess the benefit of the concomitant use of a Moisturizing Lotion in reducing the skin irritation induced by a adapalen gel treatment in Chinese Subjects.
详细描述
The interest & relevance of the concomitant use of a non-comedogenic moisturizer in order to decrease retinoid irritation has already been demonstrated in Caucasian patients. Such interest of associating a moisturizer when Differin® gel is prescribed has not been demonstrated in Asian populations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male or female subjects of Chinese origins
- •aged 21 years or older
- •with healthy skin;
排除标准
- •skin pigmentation which interferes with the reading of skin reactions
- •with sunburn, eczema, atopic dermatitis, perioral dermatitis, or rosacea on the area to be treated
- •with a washout period for the following topical treatment(s) Corticosteroids, oher anti-inflammatory drugs, retinoids
- •with a washout period for the following systemic treatment(s): Medications that may increase photosensitivity, corticosteroids, anti-inflammatories, retinoids
研究组 & 干预措施
intra-individual comparison
干预措施: adapalen 0.1% (Drug)
intra-individual comparison
干预措施: Cetaphil® (Other)
结局指标
主要结局
Pruritus
时间窗: at 4 weeks
score from 0 (none) to 3 (severe)
Scaling
时间窗: at 4 weeks
score from 0 (none) to 3 (severe)
Dryness
时间窗: at 4 weeks
score from 0 (none) to 3 (severe)
Stinging/Burning
时间窗: at 4 weeks
score from 0 (none) to 3 (severe)
Erythema Rating Scale
时间窗: at 4 weeks
score from 0 (none) to 3 (severe)
次要结局
未报告次要终点