Spironolactone in the Treatment of Hidradenitis Suppurativa: A Prospective, Open-Label Proof-of-Concept and Dose-Ranging Study
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Proportion of patients with 2 grade improvement in Hidradenitis Suppurativa as assessed by physicians global assessment score
研究概览
简要总结
The purpose of this study is to evaluate if the drug spironolactone - which is used to treat acne and male pattern hair growth in women - is effective in treating hidradenitis suppurativa in females and which dose of the drug works the best. Participation in this study will take about 4 clinic visits over approximately 7 months with the option to continue for longer if desired.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group 1
Patients taking 50mg Spironolactone
干预措施: Spironolactone 50 MG (Drug)
Group 2
Patients taking 100mg Spironolactone
干预措施: Spironolactone 100mg (Drug)
Group 3
Patients taking 200mg Spironolactone
干预措施: Spironolactone 200 mg (Drug)
结局指标
主要结局
Proportion of patients with 2 grade improvement in Hidradenitis Suppurativa as assessed by physicians global assessment score
时间窗: Baseline through one year
The proportion of patients achieving a clinical response - defined as at least a 2-grade improvement in Hidradenitis Suppurativa Physician's Global Assessment (HS-PGA) score relative to baseline at 6 months. HS-PGA is an anchored 6-stage HS-specific physician global assessment scale that was defined for use in a phase-II clinical trial. It is based on the number and type of nodules, abscesses, and fistulas.
次要结局
- Tolerability of spironolactone as measured by incidence of patient reported and physician observed treatment-related adverse events(Baseline through one year)
- Proportion of patients achieving clinical response at month 3(Baseline through 3 months)
- Proportion of patients achieving clinical response at any study visits during the optional treatment extension period of up to 1 year(Baseline through one year)
- Change in patient-reported disease activity(Baseline through one year)
- Comparison between group treatment effects(Baseline through one year)