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临床试验/NCT07751549
NCT07751549已完成不适用

Evaluation of the Efficacy and Safety of Systemic Metformin, Topical Metformin 30%, and Glycolic Acid 70% Chemical Peel in the Treatment of Patients With Acanthosis Nigricans: A Randomized Comparative Study

Tanta University1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2023年6月3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
54
试验地点
1
主要终点
Change in Acanthosis Nigricans Area and Severity Index (ANASI) score

研究概览

简要总结

Acanthosis nigricans (AN) is a common dermatologic condition associated with insulin resistance and obesity. Existing treatment options often provide inconsistent results. This randomized, single-blinded, parallel-group clinical trial was conducted to evaluate and compare the efficacy and safety of systemic metformin, topical metformin 30%, and 70% glycolic acid chemical peel in the treatment of patients with acanthosis nigricans.

Fifty-four patients with clinically diagnosed acanthosis nigricans were randomly assigned to receive oral metformin, topical metformin 30%, or glycolic acid 70% chemical peel. Clinical efficacy was assessed using the Acanthosis Nigricans Area and Severity Index (ANASI), Global Aesthetic Improvement Scale (GAIS), dermoscopic evaluation, patient satisfaction, and safety outcomes. The study aimed to determine whether topical metformin provides efficacy comparable to systemic metformin while reducing treatment-related adverse effects.

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
Single (Outcomes Assessor)

入排标准

年龄范围
11 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of acanthosis nigricans. Age 11 years or older. Male or female participants. Willingness and ability to comply with the study protocol and provide written informed consent (or assent with parental/guardian consent for minors, as applicable).

排除标准

  • Pregnancy or lactation. History of keloid formation or post-peel hyperpigmentation. Active skin infection. Malignant acanthosis nigricans. Use of other treatments for acanthosis nigricans within the previous 3 months.

研究组 & 干预措施

systemic metformin

Active Comparator

干预措施: systemic metformin (Drug)

topical metformin

Active Comparator

干预措施: topical intervention (Drug)

glycolic acid

Active Comparator

干预措施: glycolic acid 70% peeling (Procedure)

结局指标

主要结局

Change in Acanthosis Nigricans Area and Severity Index (ANASI) score

时间窗: Baseline and 3 months

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

Nesrin Sabry

Lecturer at Dermatology and Venereology

Tanta University

研究点 (1)

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