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临床试验/CTRI/2025/01/078918
CTRI/2025/01/078918尚未招募不适用

Comparison of effectiveness of topical metformin 30 percent gel vs topical benzoyl peroxide 2.5 percent gel alone in acne vulgaris a randomized non inferiority open label study

IMS AND SUM HOSPITAL1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2025年2月1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
96
试验地点
1
主要终点
Compare the decrease in lesional count

研究概览

简要总结

The patients meeting all the inclusion criteria and not meeting any exclusion criteria shall be considered to participate in the study

A detailed history including the duration of disease, associated medical conditions, treatment history and family history is to be taken

The patients are randomized according to random number generator and allocated to two interventional group

Assessor shall be blinded

Two medications shall be given

One group will be given topical metformin 30% gel once daily application at night for 8 weeks

The other group will be given topical benzoyl peroxide 2.5% gel once daily application at night in acne for 8 weeks

Acne lesions were counted and documented according to type (comedones, papules, pustules, nodules) at the first visit and every follow up

Follow up is done at baseline, 4th, 8th, 12th and 16th week

Clinical photographic assessment and quantitative assessment by counting the number of facial inflammatory lesions will be done at every 4 weeks till 16 weeks

Global assessment of improvement should be done by the investigator at each visit, according to the following criteria - excellent for greater thant 75% improvement, good for about 50% improvement, fair for about 25% improvement and poor for little or no improvement

Any patient developing side effects shall be pulled out of intervention

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 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • All clinically diagnosed cases of acne vulgaris cases more than 18 years of age consenting for the study.

排除标准

  • Pregnancy and lactation Patients who received any systemic/topical treatment within 1 month prior to enrollment.
  • Patients with acne Tarda Nodulocystic acne Females on Oral Contraceptive pills H/O liver or Kidney dysfunction, diabetes Those with features of hyperandrogenism like hirsutism, irregular menses, FPHL.

结局指标

主要结局

Compare the decrease in lesional count

时间窗: At baseline, 4 weeks, 8 weeks

次要结局

  • To assess the quality of life(At baseline, 4 weeks, 8 weeks)

研究者

发起方
IMS AND SUM HOSPITAL
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dr Bikash Ranjan Kar

IMS and SUM Hospital

研究点 (1)

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