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临床试验/NCT05600673
NCT05600673已完成1 期

Efficacy of Combined CO2 Fractional Laser With Bimatoprost 0.03% in Treatment of Alopecia Areata

Ahmed Hassan Nouh MD1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年1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
30
试验地点
1
主要终点
Hair regrowth

研究概览

简要总结

The goal of this study is to evaluate the efficacy and safety of combined CO2 fractional laser with Bimatoprost 0.03% as novel treatment of alopecia areata.

The main question to study is will the bimatoprost facilitate hair growth if added to fractional CO2 laser treatment in Alopecia areata.

详细描述

The study included 30 patients who were diagnosed clinically and dermoscopically as alopecia areata with age ranged between 16-55 years. The patients are divided into 2 groups: Group I, received fractional laser sessions with immediate and daily Bimatoprost application and Group II, received only frequent Laser sessions. Laser sessions were given to each patch once every 3 weeks, the procedure was repeated for 3 times.

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
16 Years 至 55 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with alopecia areata of the scalp (multilocuolaris or single patch).
  • Patient aged from 16- 55 years old in both sex.
  • Other treatment wash out period is two months.

排除标准

  • Ophiasis pattern and other patterns of alopecia areata.
  • Chronic diseases of liver, heart, kidney and blood
  • Pregnant women
  • Infections of skin in site of intervention

研究组 & 干预措施

CO2

Active Comparator

Each patient received only three CO2 fractional laser sessions 3 weeks apart

干预措施: CO2 fractional laser (Device)

Bimatoprost + CO2

Experimental

Each patient received three CO2 fractional laser sessions 3 weeks apart with immediate and subsequent daily Bimatoprost 0.03%,1 drop for each 1cm².

干预措施: Bimatoprost 0.03% solution (Drug)

Bimatoprost + CO2

Experimental

Each patient received three CO2 fractional laser sessions 3 weeks apart with immediate and subsequent daily Bimatoprost 0.03%,1 drop for each 1cm².

干预措施: CO2 fractional laser (Device)

结局指标

主要结局

Hair regrowth

时间窗: 9 weeks

Efficacy of treatment assessed using a prognostic scoring system proposed by Mcdonald Hull and Norris for density, pigmentation, and texture of growing hair. Grade 1 - Regrowth of vellus hair Grade 2 - Regrowth of sparse pigmented terminal hair Grade 3 - Regrowth of terminal hair with patches of alopecia Grade 4 - Regrowth of terminal hair on scalp

次要结局

  • Side effects(9 weeks)
  • Follow up assessment(9 weeks)

研究者

发起方
Ahmed Hassan Nouh MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ahmed Hassan Nouh MD

Lecturer of Dermatology, Venereology and Andrology department

Al-Azhar University

研究点 (1)

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