Combined Topical 5% Minoxidil and Potent Topical Corticosteroid Versus Intralesional Corticosteroid in the Treatment of Alopecia Areata A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Clinical assessment using SALT score (Severity of Alopecia Tool score)
研究概览
简要总结
Alopecia areata (AA) presents with circumscribed patches of non-scarring hair loss. It inflects a significant psychological and social burden. Many treatment options are used for the treatment of AA. Randomized controlled trials comparing intralesional and topical therapy and comparing combinations are few.
The aim of this work is to evaluate the efficacy of combined topical 5% minoxidil and potent topical corticosteroid therapy compared to intralesional triamcinolone injection in alopecia areata
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
- Single (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 presenting with scalp alopecia areata, patchy type, of at least 2 months duration.
排除标准
- •Alopecia totalis and alopecia universalis.
- •Alopecia areata solely affecting the beard.
- •Pregnant and lactating.
- •Patients known to have autoimmune diseases e.g. autoimmune thyroid disease, vitiligo or SLE.
- •Patients receiving systemic treatment relevant to alopecia areata within 3 months before enrollment into the study or topical treatment relevant to alopecia areata within 2 months before.
- •Patients with a dermatological condition affecting the scalp other than AA: e.g. psoriasis, eczema.
- •Patients with psychiatric illness or psychological state interfering with compliance or influencing the expectation of the patient.
研究组 & 干预措施
Topical therapy group
Minoxidil 5% topical solution applied twice daily and topical clobetasol propionate 0.05% cream applied once daily every night
干预措施: clobetasol propionate (Drug)
Intralesional group
intralesional triamcinolone acetonide 5 mg/ml monthly
干预措施: Triamcinolone Acetonide (Drug)
Topical therapy group
Minoxidil 5% topical solution applied twice daily and topical clobetasol propionate 0.05% cream applied once daily every night
干预措施: Minoxidil 5 % Topical Spray (Drug)
结局指标
主要结局
Clinical assessment using SALT score (Severity of Alopecia Tool score)
时间窗: 3 months
SALT score is a quantitative assessment scale for the evaluation of percentage of scalp hair loss. The percent surface area of each of the 4 scalp is determined: Vertex (top): 40% (0.4) of scalp surface area; each side of scalp (right and left profile): each 18% (0.18) of scalp surface area; posterior aspect (back) of scalp: 24% (0.24) of scalp surface area. The percentage of hair loss in any of these 4 aspects is calculated as the percentage of hair loss multiplied by percent surface area of the scalp in that area. SALT score is the sum of product of each section in the above mentioned areas. SALT score is calculated before and after therapy. Lowest value: 0%: indicates abscence of clinical disease, Highest value: 100%: indicate 100% affection of the scalp
次要结局
- Quantitative measurement of Transforming growth factor-beta 1 (TGF-β1)(3 months)
- Quantitative measurement of Interleukin-23 (IL-23)(3 months)
- Dermoscopic evaluation(3 months)
研究者
Mona El-Kalioby
Principal investigator
Cairo University