Topical metformin in the treatment of melasma: A preliminary clinical trial.
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
- safety
研究概览
简要总结
Melasma is a common acquired pigmentary disorder that manifests as symmetric hyperpigmented macules and patches on the face,more frequently affects women of reproductive age with darker skin type. Melasmaposes a therapeutic challenge because of its recalcitrant & recurrent nature.Ideal treatment option for this cosmetically embarrassing condition is effective depigmentation without any adverse effects. Numerous therapeutic modalities have been tried for this condition, triple combination cream(hydroquinone+steroid+tretinoin) remains the gold standard of treatment for this condition, but their prolonged use can result in serious adverse effects.Recent studies have shown that metformin has melanopenic action when applied topically.Hence, this study will be undertaken to evaluate the efficacy and safety of topical metformin and to compare its efficacy with that of triple combination cream (hydroquinone 2%+ tretinoin 0.025% +fluocinolone acetonide 0.01%), which is already proven to be efficacious in the treatment of melasma. Twenty patients in group 1 will be treated with topical metformin, 20 patients in group 2 will be treated with TCC i.e, (hydroquinone 2%+ tretinoin 0.025% +fluocinolone acetonide 0.01%)
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 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients having melasma of more than 18 years age.
- •Patients who are not on topical medications for melasma treatment for atleast 2 weeks , 1 month for systemic steroids, 3 months for laser, dermabrasion or peels.
- •Patients who are willing to participate in the study.
排除标准
- •Pregnant and lactating women 2) Patients on oral contraceptives, phenytoin 3) Patients with renal dysfunction.
- •Patients who are allergic to the investigating medications.
- •Patients with acne vulgaris, rosacea.
结局指标
主要结局
safety
时间窗: 8 weeks
次要结局
- Improvement in Melasma area and severity index score(8 weeks)
