A Pilot Study of Azelaic Acid as a Novel Treatment for Central Centrifugal Cicatricial Alopecia
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Amount of hair loss regression
研究概览
简要总结
The purpose of this pilot study is to determine if azelaic acid shows potential to be an effective treatment for Central Centrifugal Cicatricial Alopecia (CCCA). In this study, the aim is to compare azelaic acid vs placebo since azelaic acid may increase anti-inflammatory effects that affect the hair growth cycle.
详细描述
The management of Central Centrifugal Cicatricial Alopecia (CCCA) is challenging due to limited current treatments and a lack of randomized controlled trials. Management focuses on behavioral and styling modifications, in addition to symptomatic relief. Any potentially damaging hair care practices such as chemical relaxers, heat application to the scalp, and the use of hardening gels and sprays are discouraged. Many commonly used therapies are anti-inflammatory in nature, including intralesional steroids, topical steroids, oral antibiotics and increased frequency of hair washing with antidandruff shampoos. These treatments not only lead to improvement in pruritus and tenderness, but in some cases result in increased hair density. Currently, comparison studies of different treatments for CCCA subjects is limited. The aim is to determine if there is an advantage in using one particular anti-inflammatory therapy over another for relieving symptoms and promoting hair follicle regrowth.
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 eighteen years of age or older
- •biopsy-proven and /or clinical diagnosis of CCCA Stage II-IV
- •on stable treatment without changes for at least three months
- •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
control (no additional treatment)
Subjects will continue to use their current primary provider prescribed topical formulation once daily on the scalp. The subjects will use their treatment for a total of 6 months.
干预措施: usual medication for CCCA (Other)
azelaic acid treatment
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: azelaic acid (Drug)
结局指标
主要结局
Amount of hair loss regression
时间窗: Month 6
measured by standardized photos and dermatoscope photos
Amount of hair loss regression
时间窗: Baseline
measured by standardized photos and dermatoscope photos
Amount of hair loss regression
时间窗: Month 2
measured by standardized photos and dermatoscope photos
Amount of hair loss regression
时间窗: Month 4
measured by standardized photos and dermatoscope photos
次要结局
- Amount of alleviation of signs and symptoms of disease(Months 2, 4, and 6)
- Amount of hair regrowth(Months 2, 4, and 6)
- Dermatology Life Quality Index (DLQI)(Baseline and Month 6)