Efficacy and Safety of Topical Metformin in Psoriasis Vulgaris: A Randomized, Double Blinded, Placebo-controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Comparison of percent PASI improvement from baseline between the topical metformin and placebo groups.
研究概览
简要总结
The goal of this clinical trial is to learn if topical metformin works to treat mild psoriasis vulgaris. It will also learn about the safety of topical metformin. The main questions it aims to answer are:
Does topical metformin improve psoriatic plaques in early psoriasis? What medical problems do participants have when use topical metformin? Researchers will compare topical metformin to a placebo (a look-alike substance that contains no drug) to see if topical metformin works to treat psoriasis vulgaris.
Participants will:
put topical metformin or placebo twice daily for 2 months. Visit the clinic once every months for follow up. Keep a diary of their symptoms and any side effects.
Skin biopsy will be taken from psoriatic plaque before starting treatment and another one will be taken after 2 months of starting treatment to assess the level of IL-17.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 18 years old
- •Patients of both genders
- •Patients with mild chronic plaque psoriasis ((PASI) < 10, and body surface area (BSA) < 10% and/or Dermatology Life Quality Index (DLQI) <10).
排除标准
- •Intake of anti-psoriatic systemic therapy within the last 3 months apart from retinoids, or topical treatments within the last 2 weeks.
- •Intake of systemic metformin.
- •Intake of other systemic drugs that exacerbate psoriasis as anti-malarial drugs, Angiotensin- converting-enzyme inhibitors (ACEI), Ca channel blockers (CCBs) and beta blockers or intake of non-steroidal anti- inflammatory drugs (NSAID) within the last 2 weeks.
- •Patients with psoriatic arthritis.
- •Patients with pustular psoriasis.
- •Pregnant and Lactating females.
研究组 & 干预措施
Metformin
patient with mild psoriasis with PASI less than 10% will receive topical metformin 30% cream twice daily
干预措施: Topical metformin 30% cream (Drug)
Placebo
patients with mild psoriasis vulgaris will receive placebo cream twice daily
干预措施: Placebo (Drug)
结局指标
主要结局
Comparison of percent PASI improvement from baseline between the topical metformin and placebo groups.
时间窗: 8 weeks after starting treatment
Assessment and comparison of tissue levels of interleukin 17 (IL - 17) between the topical metformin and placebo group.
时间窗: 8 weeks after starting treatment
次要结局
- Comparison of percentage of patients who achieved ≥4-point improvement from baseline worst itch numeric rating score (WI- NRS) between the topical metformin and placebo groups.(8 weeks after starting treatment)
研究者
Yasmine Ahmed Mahmoud Obaid
Resident
Cairo University