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临床试验/NCT05885269
NCT05885269已完成1 期

Comparative Efficacy of Tacrolimus 0.1% and Clobetasol Propionate 0.05% in the Treatment of Alopecia Areata

Combined Military Hospital Abbottabad1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
The degree of response was assessed on The basis of hair regrowth as excellent, marked, moderate or slight.

研究概览

简要总结

Methodology: The 70 patients of age 20 to 50 years presented to the out-patient department of CMH Abbottabad suffering from alopecia areata were enrolled. The non-probability consecutive sampling technique was used. Patient in group-A applied clobetasol propionate 0.05% twice daily, whereas Group-B applied topical tacrolimus 0.1% twice daily for upto 3 months. The Patients were assessed at baseline, 4th weeks, 8th week and 12th week after treatment of each session. Hair loss was calculated from SALT score at presentation and on follow-up after 3 months. The degree of response was assessed on the basis of hair re-growth as excellent (>75% re-growth), Marked (51-75% re-growth), moderate (26-50% re-growth), or slight (≤25% re-growth). To determine statistical significance χ2-square test, taking p-value <0.05 as significant, was used.

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
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients age 20 to 50 years
  • Both male and female
  • Duration of illness less than 2 months
  • those who never received any treatment before

排除标准

  • Patients having duration of alopecia greater than 2 months
  • Atypical alopecia areata i.e., Alopecia universalis etc
  • Hypersensitivity history to topical corticosteroids or tacrolimus
  • patients taking any systemic immune suppression
  • pregnancy/lactation

研究组 & 干预措施

Group A applied Clobetasol Propionate 0.05%

Active Comparator

Patient in group-A applied clobetasol propionate 0.05% twice daily for upto 03 months.

干预措施: Group A applied topical Clobetasol Propionate (Drug)

Group B applied topical Tacrolimus 0.1%

Active Comparator

Group-B applied topical tacrolimus 0.1% twice daily for upto 3 months.

干预措施: Group B applied topical Tacrolimus (Drug)

结局指标

主要结局

The degree of response was assessed on The basis of hair regrowth as excellent, marked, moderate or slight.

时间窗: 6 months

The degree of response was assessed on the basis of hair regrowth as excellent (\>75% regrowth), marked (51-75% regrowth), moderate (26-50% regrowth), or slight (≤25% regrowth)

次要结局

未报告次要终点

研究者

发起方
Combined Military Hospital Abbottabad
申办方类型
Other
责任方
Principal Investigator
主要研究者

danyal sajjad

Principal investigator

Combined Military Hospital Abbottabad

研究点 (1)

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