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
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
Dr Bikash Ranjan Kar
IMS and SUM Hospital
