To determine the efficacy of sunscreens in the treatment of melasma as assessed by MASI and Hindi Melasma Quality Of Life Index
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Sunlight has been proposed as one of the most important triggering event in the etiopathogenesis of melasma. However there are very few studies that evaluate its role in the treatment of melasma. Also, the impact of melasma and its treatment on the quality of life has assessed by the Hindi Melasma Quality Of Life Index has not been assessed before in the Indian setup.
研究概览
简要总结
Sunlight has always been considered an important triggering factor in the pathogenesis of melasma and sunscreens are considered mainstay of treatment of melasma.However,there are hardly any studies from India or Asia evaluating the role of sunscreens in the treatment of melasma or its effect on the Melasma Quality of Life of the patients.This study is a single arm interventional study which has been undertaken on 100 Indian patients of melasma to evaluate the effectiveness of a broad band sunscreen in the treatment of melasm alone in Indian patients over a period of 12 weeks using the validated Hindi Melasma Quality of Life(Hindi MELASQOL )on patients.,which will be the primary outcome on patients.The secondary outcome would be evaluation of tolerability of the sunscreen in the treatment of melasma in Indian patients.A correlation of MASI(melasma area and severity index) and Hindi MELASQOL will also be done in the patients.Before and after photography will also be done in patients to assess treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with clinical diagnosis of Melasma.
- •Naïve patients, not on any therapy.
排除标准
- •1.Age less than 20 years.
- •2.History of intake of Oral contraceptives 3.History of photosensitivity 4.Pregnant/nursing patient 5.Patient taking photosensitizing medications 6.Family history of melasma 7.Thyroid abnormality.
结局指标
主要结局
Sunlight has been proposed as one of the most important triggering event in the etiopathogenesis of melasma. However there are very few studies that evaluate its role in the treatment of melasma. Also, the impact of melasma and its treatment on the quality of life has assessed by the Hindi Melasma Quality Of Life Index has not been assessed before in the Indian setup.
时间窗: 12 weeks
次要结局
- To observe tolerability to sunscreen of the patients over 12 weeks(12 weeks)