Therapeutic outcome of Diphencyprone and its correlation with lesional immune cell subtypes and serum cytokine profile in alopecia areata-A pilot study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To study the therapeutic outcome of diphencyprone in extensive alopecia areata
研究概览
简要总结
Extensive alopecia areata and those refractory to conventional modalities are treated using topical immunotherapy like diphencyprone. Few studies have in the past reported varying regrowth rates ranging from 4 to 83%, averaging at 50%. It is essential to delineate the efficacy and safety of this treatment modality in our setting. Diphencyprone use is associated with an elevated number of infiltrating leukocytes in the bulbar and suprabulbar area of the hair follicle, apparently newly recruited leukocytes act against autonomously functioning CD4+ and CD8+cells.Very few studies in the past have been conducted to investigate the immune alterations in the scalp that resulted in hair regrowth. Enhanced T-cell-mediated immunity and breakdown of immune tolerance due to deficiency in Tregs may facilitate the occurrence of alopecia areata. Diphencyprone treatment has been associated with decrease in the raised interferon-gamma levels, increase in mRNA expression of interleukins 2, 8, 10, and tumor necrosis factor-alpha in the lesional skin. The drug probably also has a systemic effect even after local administration, as evidenced by regrowth of hair at sites distant from the site of application. The serum cytokine profile of patients following diphencyprone treatment has not been studied.
The research questions are
What is the efficacy of diphencyprone in alopecia areata?
What is the change in immune cell population at the site of treatment with diphencyprone?
What is the change in cytokines of T-helper cells (Th1, Th2 and Th17) and regulatory T cells (Tregs) with diphencyprone treatment in alopecia areata and its clinical correlation?
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Extensive alopecia areata(more than 30 percent scalp hair loss).
排除标准
- •1.Patients who have taken any systemic or topical therapy in the last 1 month 2.Concomitant serious intercurrent illness 3.Liver failure 4.Significant cardiovascular disease 5.Pregnant and lactating women 6.Women of child-bearing potential not using contraception 7.Past or current history of tobacco or alcohol use.
结局指标
主要结局
To study the therapeutic outcome of diphencyprone in extensive alopecia areata
时间窗: 6 months
次要结局
- 1.To study the lesional cell subtypes and serum cytokine profile in patient with alopecia areata(2.To study the clinical correlation of cytokines of T-helper and regulatory T cells and lesional immune cell types on treatment with diphencyprone)