CTRI/2024/09/074120尚未招募2 期
Topical 5 percent spironolactone versus placebo in the management of acne vulgaris - A randomised controlled trial
Base Hospital Lucknow1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2024年10月1日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- 50% improvemnt in acne severity
研究概览
简要总结
Background: Acne is a common skin condition. The treatment options for managing acne include topical antibiotics, topical retinoids, systemic antibiotics and retinoids depending on the severity of the disease. Oral spironolactone is used in the management of hormonal acne. Oral spironolactone is associated with anti-androgen adverse effects such as menstrual irregularity and breast tenderness.
Purpose: This trial aims to study the efficacy of compounded topical spironolactone. The outcome will be measured at 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female patients suffering from mild to moderate acne (Grade 1 and 2) Not on any topical or systemic treatment for last 1 month.
排除标准
- •Pregnant and lactating female severe acne comorbid disease.
结局指标
主要结局
50% improvemnt in acne severity
时间窗: at 2 weeks, 4 weeks and 6 weeks
次要结局
- Physcian global assessment(6 weeks)
研究者
Shekhar Neema
Base Hospital
研究点 (1)
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