Clinical Trial on the Efficacy of Intralesional Triamcinolone Versus Candida Albicans Antigen in Treating Alopecia Areata
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Treatment response
研究概览
简要总结
The efficacy of two intralesional treatment modalities for alopecia areata will be determined. Thirty patients over the age of 6 with the diagnosis of alopecia areata on the scalp, with an extension of less than 50%, will be included. A comparison will be made between the effectiveness of intralesional Triamcinolone (standard first-line treatment) and intralesional Candida albicans antigen, with serial clinical and trichoscopic pictures at follow-up to evaluate the clinical response and associated adverse effects.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of alopecia areata
- •SALT score of less than 50% extension
- •Has not received any topical or systemic treatment in the last month
- •Signed informed consent
排除标准
- •Any skin condition on the scalp (infectious, inflammatory or neoplastic) that could modify the clinical of trichoscopic features
- •Pregnancy or breast-feeding
- •Patients in medications that could cause hair loss as side-effects
研究组 & 干预措施
intralesional Triamcinolone
Triamcinolone acetonide will be administered intralesionally at a concentration of 4 mg/mL. The solution will be injected in 0.1 mL doses, spaced 1 cm apart. The maximum total dose per session will be limited to 3 mL
干预措施: Candida Albicans Antigen Injection (Drug)
Candida albicans antigen
Single subcutaneous administration of 0.1 mL of Candida albicans antigen into one of the alopecic patches
干预措施: Candida Albicans Antigen Injection (Drug)
结局指标
主要结局
Treatment response
时间窗: 5 months
porcentage of hair growth determined by SALT score
次要结局
- Side effects(5 months)
研究者
Erika Lizbeth Alba Rojas
Erika Alba Rojas
Universidad Autonoma de Nuevo Leon