Cetaphil® Daily Facial Moisturizer With Sunscreen SPF 50+ - Human Repeat Insult Patch Test Skin Irritation/Sensitization Evaluation (Semi-occlusive Patch)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Area of Erythema and Elevated Responses of Skin to Product
研究概览
简要总结
This study examined the possible sensitization and irritation effects of a moisturizer with sunscreen SPF 50+.
详细描述
The design for this study is standard for human repeat insult patch tests. To test the moisturizer with sunscreen SPF 50+ for the potential to induce contact sensitization by repetitive applications, healthy subjects received 9 applications at 48 to 72 hour intervals of the moisturizer to the upper back. Patches were remained on the skin for approximately 48 to 72 hours. Twelve to 24 days after the previous applications, subjects were patched with the moisturizer at the original site and an alternative site for 48 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women 18 to 70 years of age in general good health
- •Can read, understand, and sign informed consent
排除标准
- •History of acute or chronic disease
- •Diagnosed with chronic skin allergies
- •Pregnant or lactating
研究组 & 干预措施
Facial Moisturizer with SPF 50+
All subjects received Cetaphil Daily Facial Moisturizer with SPF 50+
干预措施: Facial Moisturizer with SPF 50+ (Drug)
结局指标
主要结局
Area of Erythema and Elevated Responses of Skin to Product
时间窗: 3 consecutive weeks
Subjects were patched 9 times at 48 hour to 72 hour intervals and graded for erythema and elevated responses (edema, papules, vesicles, bullae) on a 4 point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe). 12 to 24 hours after the last patch application, a challenge patch was applied at the same site and a challenge patch was applied to an alternate site. Both were graded for the same criteria at 48 hours and at 96 hours. A total of 11 patches were applied to each subject. All patches were removed after 48 hours.
次要结局
未报告次要终点