A Pilot Study of Calcipotriol as a Novel Treatment for Central Centrifugal Cicatricial Alopecia
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Amount of hairline stabilization
研究概览
简要总结
The purpose of this pilot study is to determine if calcipotriol shows potential to be an effective treatment for Central Centrifugal Cicatricial Alopecia (CCCA). This study aims to evaluate calcipotriol due to the possible anti-inflammatory effects that may affect the hair growth cycle.
详细描述
Calcipotriol, a vitamin D analog, has been topically used to treat alopecia areata, a form of non-scarring autoimmune alopecia in several studies. It is possible that Vitamin D plays a role in sustaining the hair follicle's immune privilege through anti-inflammatory effects such as controlling Interferon gamma (IFN-γ) production. A recent study showed a significant decrease of vitamin D in Black patients with Central Centrifugal Cicatricial Alopecia (CCCA)"
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who are eighteen years of age or older
- •biopsy-proven and/or clinical diagnosis of CCCA Stage II-IV
- •must be on stable treatment without changes for at least 3 months
- •Subjects will be recruited from outpatient dermatology clinics at the Wake Forest Baptist Health Department of Dermatology.
排除标准
- 未提供
研究组 & 干预措施
Calcipotriol Group
Subjects will use the topical formulation once daily on the scalp. The subjects will use the treatment for a total of 6 months.
干预措施: Calcipotriol (Drug)
Control Group
Subjects will continue to use their primary physician prescribed topical formulation once daily on the scalp. The subjects will use their treatment for a total of 6 months.
干预措施: Subject's already prescribed drug (Drug)
结局指标
主要结局
Amount of hairline stabilization
时间窗: Month 6
Standardized camera and dermatoscopic photographs
次要结局
- Signs and symptoms of disease score(Month 2, Month 4, and Month 6)
- Dermatology Life Quality Index score(Baseline and Month 6)
- Amount of hair regrowth(Baseline, Month 2, Month 4, and Month 6)