CTRI/2024/11/076845尚未招募不适用
Comparison of effectiveness of topical metformin 30% plus 4%hydroquinone cream vs topical hydroquinone 4% cream alone in melasma -A randomised non inferiority open lable study
SOA university2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年11月22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
- 60
- 试验地点
- 2
- 主要终点
- on photographic assessment and quantitative assessment using mMASI score.
研究概览
简要总结
Patient meeting the clinical criteria divided into two group. One group to receive metformin 30 % cream plus hydroquinone cream and the other group to receive only hydroquinone cream .Low cost of metformin tablets and ease of preparation of desired formulations makes its a cost effective option for the management of melasma.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •.All clinically diagnosed cases of melasma cases from 18 to 60 years of age
- •Who are not currently on any topical or systemic melasma treatments for one month and who did not receive any cosmetic procedures such as laser ablation, dermabrasion or peels for the last 3 months.
排除标准
- •Pregnancy and lactation
- •Active acne vulgaris and Rosacea
- •Females on Oral Contraceptive pills
- •History of allergy to metformin
- •Allergic to propylene glycol
- •H/O liver or Kidney dysfunction.
结局指标
主要结局
on photographic assessment and quantitative assessment using mMASI score.
时间窗: Assessment to be done on every monthly for 4 months
次要结局
- SAFETY PROFILE(Any patients developing side effects like pruritus, allergic reactions, erythema)
研究者
NIBEDITA DIXIT
IMS AND SUM HOSPITAL
研究点 (2)
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