A comparative study of safety and efficacy of topical Metformin lotion versus Zinc oxide cream in the treatment of melasma
试验速览
- 阶段
- 2/3 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 intensity of pigmentation
研究概览
简要总结
Melasmais a common, acquired disorder of melanogenesis leading to hyperpigmentationand characterized by irregular symmetrical brown to gray-black macules on theface.Melasmamanagement is difficult because of its frequent relapse. The first thing to dois to eliminate risk factors if possible and to avoid exposure from the sun.
Recently, studieshave shown that topical metformin has melanopenic action, which is due todownregulation of the expression of MITF which in turn leads to downregulationof transcription of various melanogenic proteins such as tyrosinase, TRPâ€1,TRPâ€2, and protein kinase Câ€beta
Hence, this study was undertaken to evaluate the safety andefficacy of topical metformin in melasma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of both genders above 18 years who were clinically diagnosed to have melasma 2.Patients willing to give a written informed consent.
排除标准
- •Before starting the study 1.Pregnant & lactating mothers 2.Patients on oral contraceptives, phenytoin 3.Patients with unrealistic expectations 4.Patients who are allergic to metformin 5.Patients on medications for melasma since at least 2 weeks for topical therapy, 1 month for systemic steroids, 3 months for cosmetic procedures such as laser, dermabrasion, or peels 6.Patients with co-morbidities-DM, SHTN, TB,CAD,EPILEPSY,BA, carcinomas, Renal dysfunction, During Study 1.If patient develops side effects during the treatment 2.If patient wants alternate treatment during the study.
- •3.If patient wants to discontinue the treatment.
结局指标
主要结局
Reduction in intensity of pigmentation
时间窗: 8 weeks after using medication
次要结局
- Prevention of relapse(1 year)