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临床试验/NCT02350023
NCT02350023已完成4 期

A Randomized Comparative Study of Efficacy and Safety of Topical Latanoprost Versus Topical Corticosteroid in the Treatment of Localized Alopecia Areata

Post Graduate Institute of Medical Education and Research, Chandigarh1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Number of patients with hair regrowth (complete, partial, or no regrowth)

研究概览

简要总结

Alopecia areata (AA) is an autoimmune disease that involves the hair follicles. Topical corticosteroids are the established agents for treating this disorder. There are several case reports and case series which have demonstrated the efficacy of topical prostaglandins. The two agents have not been compared head-to-head in the published literature. The investigators attempt to compare the efficacy and safety of topical betamethasone and topical latanoprost in the treatment of localised alopecia areata.

详细描述

Alopecia areata (AA) is an autoimmune disease that involves the hair follicles. Topical corticosteroids are the established agents for treating this disorder. Topical prostaglandins like latanoprost have also been used for this disorder. There are several case reports and case series which have demonstrated the efficacy of topical prostaglandins. However, the two agents i.e. topical corticosteroids and topical latanoprost have not been compared head-to-head in the published literature. The investigators attempt to compare the efficacy and safety of topical betamethasone and topical latanoprost in the treatment of localised alopecia areata.

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
— 至 99 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • Cases of AA involving scalp and beard area, having 5 or less patches in all, involving less than 40% area
  • Stable disease without appearance of new patch or increase in size of existing patch for at least 15 days

排除标准

  • • Pregnant and lactating women
  • Patients on topical treatment for alopecia in the past fifteen days or on systemic treatment for alopecia in the past one month
  • Presence of any contraindication for topical corticosteroids (local skin infections, skin atrophy) or latanoprost (pregnancy, lactation and dermatitis)
  • Any other coexisting hair disorder (viz., trichotillomania, androgenetic alopecia, telogen effluvium)
  • Extensive disease i.e. >5 patches of AA or area involving >40% area / alopecia totalis/ alopecia universalis/ ophiasis

研究组 & 干预措施

Topical latanoprost

Active Comparator

Topical latanoprost 0.005%

干预措施: Topical latanoprost 0.005% (Drug)

Topical betamethasone

Active Comparator

Topical betamethasone 0.05%

干预措施: Topical betamethasone 0.05% (Drug)

结局指标

主要结局

Number of patients with hair regrowth (complete, partial, or no regrowth)

时间窗: 4 months

Response to the treatment in terms of hair regrowth will be assessed. The reduction in the area affected by alopecia areata will be assessed for each patient

次要结局

  • Number of patients suffering from adverse effects(4 months)

研究者

发起方
Post Graduate Institute of Medical Education and Research, Chandigarh
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sonali Bhat

Dr

Post Graduate Institute of Medical Education and Research, Chandigarh

研究点 (1)

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