Aldara for the Treatment of Extensive Alopecia Areata
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- To determine the efficacy of Aldara Cream 5% for the treatment of extensive alopecia areata
研究概览
简要总结
We propose to examine the efficacy and tolerability of Aldara Cream 5% for the treatment of extensive alopecia areata. Aldara is a immune-response modifier. The drug induces the production of cytokines which are small, hormone-like proteins involved in cellular communication during immune responses. We hypothesize that this drug will effect the inflammatory cells present around hair follicles in patients with alopecia areata.
详细描述
Ten patients with extensive scalp alopecia areata (>95% hair loss)of less than 2 years duration will be invited to participate in this study. For six months each person will be asked to apply Aldara Cream 5% daily to the right half of the scalp. No drug will be applied to the left side. Skin biopsies will be taken of the right scalp before and at the completion of the therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must give written informed consent.
- •Must be 18 years of age, male or female of any race.
- •Subjects must have extensive scalp alopecia areata (>95% involvement) of less than 2 years duration.
- •In good general and mental health based on a medical history and physical exam.
- •Patient must be willing to refrain from all other alopecia areata treatments during the course of the study.
- •Must agree to shampoo daily with Free and Clear shampoo.
排除标准
- •History of any illness or condition that in the opinion of the investigator might confound the results of the study or pose additional risk in administering the drug to the patient.
- •Significant abnormalities on screening clinical examination.
- •Previous use of Aldara Cream 5%
- •History of drug or alcohol abuse.
- •Use of ultraviolet radiation, including tanning beds and PUVA therapy for treatment of acne, psoriasis, or any other skin condition within 2 months prior to study initiation.
- •Use of systemic or topical glucocorticoids, corticosteroids. estrogenic, progestogenic, androgenic, or antiandrogen drugs, cyclosporine, FK506 or immunotherapy with DNCB, SADBE, or DCP within 6 months of study initiation.
- •Use of a topical medication within six weeks prior to the study.
- •Alterations in thyroid medication within 6 months of study initiation.
- •Pregnant or nursing females.
结局指标
主要结局
To determine the efficacy of Aldara Cream 5% for the treatment of extensive alopecia areata
次要结局
- Assess changes in the hair follicle differentiation oand perifollicular inflammation before and after treatment with Aldara Cream5%