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临床试验/CTRI/2025/09/094032
CTRI/2025/09/094032尚未招募不适用

An open label non randomised comparative interventional study to evaluate efficacy and safety of 2% Crisaborole ointment versus 0.05% Clobetasol propionate ointment in mild alopecia areata at a tertiary care centre

Dr Priyanka Deshpande1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年10月29日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
To compare the efficacy of 2% crisaborole ointment versus 0.05% clobetasol propionate ointment in mild alopecia areata.

研究概览

简要总结

•All patients of age group 18 to 60 years with clinically diagnosed cases of Alopecia Areata, with one than one patch of hair loss attending Kle’s Dr. Prabhakar Kore Hospital will be chosen.

•Informed consent will be taken from all the patients included in the study.

•All patients will undergo a detailed history taking, general, physical, systemic and dermatological examination.

•Data will be collected by a single examiner and recorded in case record proforma.

•Patients will be explained in terms of the treatment offered in terms of expected results, duration of treatment, follow-ups, side effects to be reported and prognosis of the treatment.

•Digital photographs from all sides of the scalp will be taken using identical camera settings, patients positioning and room lighting at baseline and at every sitting.

•INTERVENTION DONE - The patients are given topical 2% Crisaborole ointment twice daily application on one  patch and 0.05% Clobetasol propionate ointment twice daily on another patch.

•The patients will be called after 1 month to assess the effectiveness of both topical medications and change from the baseline

•The patients are called after every month for a total period of 3 months.

•After 3 months, digital photographs will be compared with that at the baseline.

•Physicians  assessment of improvement will be done by alopecia areata physician global assessment score.

•Patients assessment of improvement will be recorded by VISUAL ANALOG SCALE.

•The efficacy of treatment will be calculated based on percentage of hair regrowth.

•The safety of treatment will be assessed by the side effects associated with the treatment.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • All patients between age eighteen to sixty years with more than one patch of alopecia areata.

排除标准

  • Alopecia totalis, Alopecia universalis
  • conditions with other types of hairloss like frontal fibrosing alopecia, DLE, trichotillomania.
  • pregnant and breastfeeding females.

结局指标

主要结局

To compare the efficacy of 2% crisaborole ointment versus 0.05% clobetasol propionate ointment in mild alopecia areata.

时间窗: 1 year

次要结局

  • To compare the safety of 2% crisaborole ointment versus 0.05% clobetasol propionate ointment in mild alopecia areata.(1 year)

研究者

发起方
Dr Priyanka Deshpande
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Priyanka Deshapnde

Jawaharlal Nehru Medical College, Belagavi

研究点 (1)

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