跳至主要内容
临床试验/CTRI/2024/11/076396
CTRI/2024/11/076396尚未招募不适用

Comparison of effectiveness of topical metformin 30 percent cream vs topical 0.025 percent tretinoin cream in the treatment of acanthosis nigricans - A randomized non inferiority assessor blinded study.

SOA university2 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2024年11月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
74
试验地点
2
主要终点
on photographic assessment and quantitative assessment using ANSC score.

研究概览

简要总结

Patient meeting the clinical criteria will be divided into two groups. One group will receive metformin 30% cream and the other group will receive 0.025% tretinoin cream. Patient will be analysed every month for a duration of 8weeks. Metformin has a melanopenic effects because itinhibits the production of MITF which in turn inhibits the transcription of a number of melanogenic proteins.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

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

入选标准

  • All clinically diagnosed cases of acanthosis nigrican above 18 yrs of age.

排除标准

  • Pregnancy and Lactation
  • Malignancy associated AN
  • Genetic or autoimmune AN
  • Syndromic AN
  • History of allergy to metformin
  • Type II diabetes mellitus, coagulopathy, liver disease), immunocompromised hosts, infection
  • Patients not on any topical or systemic therapy for AN in last 1 month.

结局指标

主要结局

on photographic assessment and quantitative assessment using ANSC score.

时间窗: on photographic assessment and quantitative assessment to be done at 0,4,8,12 weeks

次要结局

  • safety profile(It may be discontinued if patient denies because of severe pain , edema, erythema, blisters at 0,4,8,12 weeks)

研究者

发起方
SOA university
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Nibedita Dixit

ND SUM HOSPITAL

研究点 (2)

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