An assessor blinded, randomized controlled trial comparing the safety and efficacy of oral metformin with topical 4 percent hydroquinone vs topical 4 percent hydroquinone alone in treatment of melasma in Indian skin types.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in mean MASI in both the groups
研究概览
简要总结
This study is an assessor blinded, randomized controlled trial comparing the safety and efficacy of oral metformin with topical 4% hydroquinone vs topical 4% hydroquinone alone in treatment of melasma in Indian skin types that will be conducted at AIIMS, New Delhi. The primary outcome measure is the change in the mean MASI of both the groups at the end of 3 months of intervention and 6 months. The secondary outcome measures will be change in mean MELASQoL, change in mean Melanin index, photographic improvement using physician global assessment in both the groups at the end of 3 months of intervention and 6 months; adverse reactions in both the groups at monthly follow up till 3 months, difference in the patient satisfaction score with the treatment in between the groups at the end of intervention period at 3 months.
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 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Age group more than or equal to 18 years Patients with clinical diagnosis of melasma Patients who have not received any prior medical treatment for melasma or with a wash out period of 6 weeks for any previous treatment.
- •Patients with moderate (mMASI 5.8 to 7.9) to severe Melasma (mMASI more than 7.9).
排除标准
- •Age group less than 18 years Pregnant or lactating females Patients on medications like oral contraceptives, hormone replacement therapy Patients with any current skin infections on the face. Diabetic patients Any contraindications to oral metformin.
- •Impaired renal function (serum creatinine more than 1.5 mg/dl in men and more than 1.4 mg/dl in women).
- •NYHA grade 3 or grade 4 heart failure.
- •Acute or chronic metabolic acidosis.
结局指标
主要结局
Change in mean MASI in both the groups
时间窗: at the end of 3 months of intervention and 6 months
次要结局
- Change in mean MELASQoL in both the groups(at the end of 3 months of intervention & 6 months)
- Change in mean Melanin Index in both the groups(at the end of 3 months of intervention & 6 months)
- Photographic improvement in both the groups with physician global assessment(at the end of 3 months of intervention & 6 months)
- Adverse reactions in both groups(monthly till the end of intervention period at 3 months)
- Difference in the patient satisfaction score with the treatment in between the groups(at the end of intervention period at 3 months)
研究者
Dr G Manoj Pavan Reddy
All India Institiute of Medical Sciences, New Delhi