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临床试验/CTRI/2023/07/055355
CTRI/2023/07/055355尚未招募Unknown

TO COMPARE THE EFFICACY AND SAFETY OF 15% TRICHLOROACETIC ACID PEEL WITH TOPICAL 0.05% TRETINOIN CREAM IN THE TREATMENT OF ACANTHOSIS NIGRICANS

DEPARTMENT OF DERMATOLOGY1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年7月28日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
入组人数
80
试验地点
1
主要终点
The degree of improvement will be assessed using grading system i.e., 0-25% - minimal improvement, 26-50% - moderate improvement, 51-75% - good improvement, 75% - excellent improvement.

研究概览

简要总结

Everyconsecutive patients with acanthosis nigricans will be assigned to Group A for topical0.05% tretinointherapy and group B for15% TCApeel

Thepatients in group A were advised to apply topical 0.05% tretinoin everynight as thin film to lesions of acanthosis nigricans in the neck for 2months

InGroup B 15% TCA peel willbe doneevery fortnight for 2months after skinsensitivity test(overthe post auricular area) few minutes before procedure

Regular sunscreenadvisedto both groups in the daytime

Patientswill be assessedeverymonth forthe improvement and side effects using serial photographs

研究设计

研究类型
Interventional
分配方式
Stratified randomization
盲法
Open Label

入排标准

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

入选标准

  • Patients with acanthosis nigricans willing to participate in study.

排除标准

  • Patients below 18 years and more than 60 years Pregnant and lactating mothers Patients not willing for the study Patients allergic to TCA and Tretinoin Patients planning for pregnancy.

结局指标

主要结局

The degree of improvement will be assessed using grading system i.e., 0-25% - minimal improvement, 26-50% - moderate improvement, 51-75% - good improvement, 75% - excellent improvement.

时间窗: monthly for 1 year

次要结局

  • side effects(monthly for 1 year)

研究者

申办方类型
Private medical college

研究点 (1)

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