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临床试验/NCT04680234
NCT04680234已完成不适用

Comparative Study Between the Effect of Superficial Cryotherapy Using Dimethyl Ether and Propane Mixture and Microneedling in Treatment of Alopecia Areata

Sohag University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Regrowth Scale

研究概览

简要总结

This study is randomized comparative analytical prospective study that included patients with mild and moderate alopecia areata. Patients was divided into two groups Patients in the first group underwent Superficial cryotherapy using dimethyl ether and propane (DMEP) at -57C (Cryotherapy group). Patients in the second group underwent Microneedling (Microneedling group). A total of six sessions were done at 2 weeks interval. Patients were followed-up for next 3 months to evaluate the persistence of hair regrowth after therapy. Patients were assessed at baseline and during follow up using photography, Dermoscopy, SALT score and regrowth scale.

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

入选标准

  • ِAlopecia areata patients

排除标准

  • Alopecia totalis and universalis
  • ِAge less than four years.
  • ِPregnancy or breast-feeding.
  • ِActive infection at the site alopecia patch(s).
  • ِInflammation ate site of the alopecia patches
  • ِIntolerance to cold.
  • ِAssociated systemic illness such as thyroid, pernicious anaemia, diabetes mellitus, autoimmune connective tissue diseases.
  • ِPrevious treatment for alopecia areata over the last three months.

结局指标

主要结局

Regrowth Scale

时间窗: Change in regrowth scale from baseline to 3 months follow after end of sessions

0 score (regrowth \< 10%) no response 1. score (regrowth 11-25%) poor response 2. score (regrowth 26-50%) fair response 3. score (regrowth 51-75%) satisfactory response 4. score (regrowth ≥ 75%) excellent response.

次要结局

  • SALT score(Change in salt score from baseline to 3 months follow after end of sessions)

研究者

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

Zeinab Abu elbaha Gouda

Assistant lecturer of Dermatology, Venereology and Andrology

Sohag University

研究点 (2)

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