Efficacy and Safety of Clobetasol Propionate Shampoo 0.05% Used in Association With an Antifungal Shampoo in the Treatment of Moderate to Severe Scalp Seborrheic Dermatitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 326
- 试验地点
- 1
- 主要终点
- Total Severity Score (TSS): Percent Change From Baseline at Week 4
研究概览
简要总结
The objective is to assess different treatment regimens with Clobetasol propionate shampoo 0.05% in the treatment of scalp Seborrheic Dermatitis.
详细描述
The objective is to assess different treatment regimens with Clobetasol propionate shampoo 0.05% in association with an antifungal shampoo (Ketoconazole 2%) in the treatment of moderate to severe scalp Seborrheic Dermatitis compared to the antifungal shampoo alone.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with moderate to severe scalp Seborrheic Dermatitis
排除标准
- •Subjects suffering from psoriasis,
- •Subjects with a known allergy to one of the components of the test products,
- •Female subjects who are pregnant, nursing or planning a pregnancy during the study
研究组 & 干预措施
C propionate 4/week + Ketoconasole 2/week
Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week)
干预措施: clobetasol propionate shampoo (4/week) - ketoconazole shampoo (2/week) (Drug)
C propionate 2/week + Ketoconasole 2/week
Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week)
干预措施: clobetasol propionate shampoo (2/week) - ketoconazole shampoo (2/week) (Drug)
C propionate 2/week
Clobetasol propionate shampoo 0.05% (2/week)
干预措施: clobetasol propionate shampoo (2/week) (Drug)
Ketoconazole 2/week
Ketoconazole shampoo 2% (2/week)
干预措施: ketoconazole shampoo (2/week) (Drug)
结局指标
主要结局
Total Severity Score (TSS): Percent Change From Baseline at Week 4
时间窗: baseline and week 4
Total Severity Score (TSS) is sum of erythema, scaling and pruritus severity scores of the lesions evaluated each on a 4-point scale from 0 = None to 3 = Severe by the investigator. So minimum TSS can be 0 and maximum 9.
次要结局
未报告次要终点