NCT03178994已完成3 期
The Study of Efficacy and Safety of 2% Ketoconazole Cream in Thai Females With Mild Degree of Post - Adolescence Acne
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Total numbers of acne reduction
研究概览
简要总结
To study efficacy (total numbers of acne reduction) and safety of 2% Ketoconazole cream in Thai females with Mild degree Post-Adolescence acne comparing with placebo for a period of 12 weeks.
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
- 25 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •regular menstrual cycle with mild degree of post - adolescence acne
- •agree to stop topical and systemic medication for acne treatment for 2 and 4 weeks respectively.
排除标准
- •Pregnancy or lactation
- •Other active rashes on faces.
- •Allergic to ketoconazole or other ingredients of preparation.
- •Signs of hyperandrogenism
- •Taking anti-androgenic medications.
研究组 & 干预措施
2% ketoconazole cream
Experimental
2% ketoconazole cream apply on face twice daily for 10 weeks.
干预措施: 2% ketoconazole cream (Drug)
Placebo
Placebo Comparator
Hydrophilic cream (in-house preparation) apply on face twice daily for 10 weeks.
干预措施: Hydrophilic Cream (Drug)
结局指标
主要结局
Total numbers of acne reduction
时间窗: 10 weeks
the difference of acne count (total numbers of acne before treatment - total numbers of acne after treatment)
次要结局
- Proportion of patients who achieve clear or almost clear after treatment(10 weeks)
研究者
研究点 (1)
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