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临床试验/NCT05594316
NCT05594316已完成不适用

Efficacy of Trichloroacetic Acid in Patients of Alopecia Areata : Clinico-histopathological Study

Al-Azhar University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Mac Donald Hull and Norris grading system

研究概览

简要总结

Abstract: Alopecia areata is believed to be an autoimmune disease resulting from a breach in the immune privilege of the hair follicles causing non scarring hair loss.

Methods: our study included 40 patients from may 2019 to july 2022 diagnosed clinically, dermatoscopically and pathologically as alopecia areata Data were enrolled from department of dermatology and venereology, Al-Hussein hospital.

详细描述

For each patient the following will be done :

  1. History taking including ( age, sex, disease duration, family history, history of drug intake, smoking and history of any associated disease ).
  2. All patients will give a written, informed consent for induction.
  3. Basic photographs will be taken to assess site, size (by cm), number, Extent of the patch using D5300 camera with lens (18-55).
  4. Patients will be subjected to 3 session of trichloroacetic acid (TCA) 35% one month apart.
  5. serial photographs and dermoscopic examination every month will be done and patient will be score.
  6. Efficacy will be assessed using prognostic scoring system for density, pigmentation, and texture of growing hair.
  7. histopathological examination will be done before the first session and one month after third session.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
16 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Alopecia areata multilocularis and alopecia totalis. Age from 16-60 years old. Ophiasis pattern alopecia areata.

排除标准

  • Age less than 16 and more than 60years old. Alopecia areata of the face.
  • Patient under treatment.

研究组 & 干预措施

single group

Other

Trichloroacetic acid

干预措施: Trichloroacetic acid (Drug)

结局指标

主要结局

Mac Donald Hull and Norris grading system

时间窗: 4 weeks after the end of treatment

regrowth of vellus hair, regrowth of sparse pigmented terminal hair, regrowth of terminal hair with patches of alopecia and regrowth of terminal hair on scalp.

trichoscopic parameters

时间窗: after each session and 4 weeks after the end of treatment

determine exclamation mark hairs, black dots, yellow dots and broken hairs

Scoring for density of hair regrowth

时间窗: after each session and 4 weeks after the end of treatment

No hair growth, 1%-25% growth, 26%-50% growth, 51%-75% growth and 76%-100% growth

Scoring of texture of regrown hair

时间窗: after each session and 4 weeks after the end of treatment

Fine vellus hair, Intermediate hair,Normal coarse hair

Scoring of pigmentation of regrown hair

时间窗: after each session and 4 weeks after the end of treatment

Partially pigmented, Moderately pigmented, Normally pigmented

histopathological changes

时间窗: after each session and 4 weeks after the end of treatment

appearance of lymphocytes around hair follicle, appearance of new blood vessels and size of thickness of hair follicles

Scoring of overall response at the end of the study

时间窗: after each session and 4 weeks after the end of treatment

No response, Minimal response, Moderate response, Good response and Excellent response

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hossam Mamdouh Anter Esmail

Assisstant lecturer of dermatology,venerology and andrology

Al-Azhar University

研究点 (2)

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