NCT04649502已完成3 期
Rediscovery of Metformin for the Chronic Disabling Auto-inflammatory Disease Hidradenitis Suppurativa
K.R. van Straalen1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2021年1月25日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- IHS4
研究概览
简要总结
A randomized controlled trial investigating the metformin is the treatment for hidradenitis suppurativa. Metformin combined with doxycycline will be compared to the standard treatment of doxycycline monotherapy for HS severity and the effect on the pre-diabetic condition.
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)
盲法说明
Double blind
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
- •Age ≥18 years at baseline
- •A diagnosis of HS for at least 1 year prior to baseline
- •mild to moderately active disease defined by a HS Physician Global Assessment (HS-PGA) score of 2-3 and the Refined Hurley classification of mild to moderate at baseline
- •Indication for systemic therapy; i.e. uncontrolled disease under conventional topical therapy.
- •Able and willing to give written informed consent and to comply with the study requirements
排除标准
- •Pregnant and lactating women
- •Concomitant diabetes mellitus
- •Use of antibiotics within 14 days prior to baseline
- •Use of immunosuppressing/modulating therapies within 28 days prior to baseline
- •A known allergy to metformin or doxycycline or any of the ingredients metformin or doxycycline
结局指标
主要结局
IHS4
时间窗: 24 weeks
International Hidradenitis Suppurativa Severity Score System (IHS4)
次要结局
- Metabolic syndrome(12 and 24 weeks)
- Lesion Count(12 and 24 weeks)
- HiSCR(12 and 24 weeks)
- Insulin resistance(12 and 24 weeks)
- NRS-Pain(12 and 24 weeks)
- Safety and Tolerability(up to 24 weeks)
- Pre-diabetic disorder(12 and 24 weeks)
- Flares(12 and 24 weeks)
- Treatment satisfaction(up to 24 weeks)
- DLQI(12 and 24 weeks)
- Cost-effectiveness(24 weeks)
- Bio-markers(24 weeks)
- HS-PGA(12 and 24 weeks)
研究者
K.R. van Straalen
MD.
Erasmus Medical Center
研究点 (1)
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