Topical Pentoxifylline; Metformin Versus Betamethasone in the Treatment of Alopecia Areata: a Clinical and Dermoscopic Study.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evaluation of hair regrowth in alopecia areata using SALT score.
研究概览
简要总结
To compare the efficacy and safety of topical pentoxifylline 2% gel and topical metformin 10% gel versus topical betamethasone valerate 0.1% cream, in treatment of patchy alopecia areata.
详细描述
Alopecia areata (AA) is a common tissue-specific autoimmune disease characterized by non-scaring hairloss.
Alopecia areata affects around 2.1% of the population at a point of their life. It affects both males and females without significant difference. Alopecia areata can occur at any age with a peak incidence in the twenties and thirties, however, the younger the attack, the more severe the course of the disease.
Alopecia areata is subdivided into 3 subgroups depending on the extent and site of hair loss; these are patchy alopecia areata, alopecia totalis and alopecia universalis. The most common presentation is patchy alopecia areata which presents as a rounded or oval patch(es) of hairloss.
Dermoscopy is a noninvasive tool which aids the diagnosis of alopecia areata. Characteristic dermoscopic features in AA include black dots (BDs), yellow dots (YDs), exclamation mark hairs (EHs), and broken hairs (BHs). BDs and EHs are the most specific findings in AA and correlate with disease activity, whereas YDs are seen in all the stages of the disease and correlate with disease severity.
The course of AA is unpredictable, with spontaneous remission during the first 6-12 months occurs in 30-50% of patients.
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
- 6 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical diagnosis of patchy alopecia areata of scalp involving < 50% of the total scalp confirmed by dermoscopy of both males and females.
- •patients age between 6 and 60 years old.
排除标准
- •Alopecia totalis and alopecia universalis.
- •Cicatricial alopecia.
- •Other causes of hair loss such as; endocrine or immunological disease.
- •Skin disease in the affected area.
- •Hypersensitivity or allergy to any of the treatment products used.
- •Patient using treatment (topical or systemic) for alopecia areata in the last 2 months.
- •Systemic administration of any of the three test drugs (pentoxifylline, metformin and steroids).
- •Pregnant and lactating females.
研究组 & 干预措施
Topical betamethasone
Group A will include 20 patients and will receive topical betamethasone valerate 0.1% cream.
Treatment will be applied twice daily for 6 months or until complete resolution, whichever is sooner.
干预措施: Betamethasone Valerate 0.1% Cream (Drug)
Topical pentoxifylline
Group B will include 20 patients who will receive topical pentoxifylline 2% gel.
Treatment will be applied twice daily for 6 months or until complete resolution, whichever is sooner.
干预措施: Pentoxifylline (Drug)
Topical metformin
Group C will include 20 patients who will receive topical metformin 10% gel. Treatment will be applied twice daily for 6 months or until complete resolution, whichever is sooner.
干预措施: Metformin (Drug)
结局指标
主要结局
Evaluation of hair regrowth in alopecia areata using SALT score.
时间窗: 8 months
The scalp is divided into four parts on the basis of surface area as follows: vertex or top = 40% (0.40), right side = 18% (0.18), left side = 18% (0.18) and the posterior aspect = 24% (0.24). Percentage of hair loss in any of the four areas is multiplied by the percentage of the scalp covered in that area. The SALT score is the sum of the percentage of hair loss in all the areas mentioned above.
次要结局
未报告次要终点
研究者
Nada Khaled Mohamed Mostafa
principle investigator
Assiut University