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临床试验/CTRI/2025/09/094913
CTRI/2025/09/094913尚未招募4 期

Efficacy of 15% Trichloroacetic Acid Peel versus 35% Glycolic Acid Peel in Acanthosis Nigricans – At a Tertiary Care Center in Central Karnataka

JJM MEDICAL COLLEGE1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年10月1日最近更新:
适应症

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Reduction in severity of acanthosis nigricans as assessed by Acanthosis Nigricans Severity Index (ANSI) score

研究概览

简要总结

Acanthosis nigricans is a common skin condition characterized by hyperpigmented and velvety thickened plaques, most often associated with obesity and insulin resistance. Chemical peels are frequently used to improve pigmentation and texture in such patients. This randomized, prospective, single center clinical trial is designed to compare the efficacy and safety of fifteen percent trichloroacetic acid peel with thirty five percent glycolic acid peel in patients with acanthosis nigricans. Eligible patients will be randomly allocated into two groups to receive either trichloroacetic acid peel or glycolic acid peel at regular intervals. Improvement will be assessed using validated pigmentation scores and patient satisfaction at baseline and at follow up visits. The primary outcome will be reduction in pigmentation, while secondary outcomes include improvement in skin texture and assessment of adverse effects. The findings of this study are expected to provide evidence regarding the relative effectiveness of two commonly used chemical peels in the management of acanthosis nigricans.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • All adults 18 years and older with a clinical diagnosis of AN affecting the face, neck, or elbow, or any combination of these three, who presented to the dermatology outpatient department and are willing to give consent.

排除标准

  • Pregnant and lactating females.
  • Hypersensitivity to the peeling agent.
  • Skin infection at the site of AN (herpes, pyoderma, and folliculitis).
  • History of any topical application in the last 4 weeks.

结局指标

主要结局

Reduction in severity of acanthosis nigricans as assessed by Acanthosis Nigricans Severity Index (ANSI) score

时间窗: At baseline, 2,4,6 and 8 weeks after initiation of treatment

次要结局

  • Patient satisfaction assessed by Visual Analogue Scale (VAS).(At 12 weeks.)

研究者

发起方
JJM MEDICAL COLLEGE
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Ashwini K Ajjewadermath

JJM Medical College

研究点 (1)

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