跳至主要内容
临床试验/CTRI/2018/12/016588
CTRI/2018/12/016588尚未招募2/3 期

Topical metformin in the treatment of melasma: A preliminary clinical trial.

Hassan institute of medical sciences1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年11月12日最近更新:

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)

研究者

发起方
Hassan institute of medical sciences
申办方类型
Government medical college

研究点 (1)

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