Phenotype and Cytokine Production Characteristics of T Cells From Alopecia Areata Scalp Skin Before and After Aldara 5% Cream Using Flow Cytometry
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 phenotypic characteristics of T lymphocytes infiltrating scalp dermis and epidermis in patients with extensive alopecia areata before and after treatment with Aldara Cream 5% an immunomodulatory agent.
研究概览
简要总结
It is thought that alopecia areata occurs as the result of an inappropriate response of the body's own immune system to certain substances in or around the hair follicle. We will be examining the efficacy of Aldara Cream 5% in treating extensive alopecia areata and observe its affect on the hair follicle.
详细描述
We will examine how the application of Aldara Cream 5% daily for 6 months will affect the hair follicle and the inflammation present in the skin of patients with alopecia areata. In the study we will obtain additional scalp biopsies to examine how the drug affects the quality and state of activity of the immune cells in the biopsy specimens. This type of information will provide data about the behavior of these inflammatory cells in mediating the hair loss associated with alopecia areata and how this behavior may be effected by Aldara Cream 5% treatment. Such information may be valuable to the successful management of alopecia areata.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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 be in good health.
- •No topical or systemic treatment for alopecia areata for at least 2 weeks prior to study initiation.
- •Must be at least 18 years of age and older
- •Will have to have extensive scalp alopecia areata (>95% involvement) of less than 2 years duration.
- •Willing to refrain from other alopecia areata treatments during the course of the study.
- •Will have to agree to shampoo their scalp daily with Free and Clear shampoo. Participant in "Aldara for the Treatment of Extensive Alopecia Areata" study.
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 to the patient
- •Significant abnormalities on screening clinical evaluation.
- •Previous use of Aldara Cream 5%.
- •A history of drug or alcohol abuse.
- •Use of UV 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.
- •Alterations in thyroid medication within 6 weeks of study initiation. Pregnant or nursing females. Not participating in the "Aldara for the Treatment of Extensive Alopecia Areata" study.
结局指标
主要结局
To determine the phenotypic characteristics of T lymphocytes infiltrating scalp dermis and epidermis in patients with extensive alopecia areata before and after treatment with Aldara Cream 5% an immunomodulatory agent.
次要结局
- To further characterize the functional potential of these cells using the nascent technology of intracellular cytokine staining.