Comparative efficacy and safety of topical and oral minocycline in acne vulgaris
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- 1.Reduction in the numbers of inflammatory lesions total number of inflammatory lesions
研究概览
简要总结
It is an open label randomized clinical study in which efficacy and safety of topical minocycline gel 4% will be compared with oral minocycline extended release tablets over a period of six weeks with follow up at every two weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •All consecutive patients of acne vulgaris GRADE I AND GRADE II with inflammatory lesions with four weeks of non- treatment.
- •Patients between 18 to 50 years.
排除标准
- •Pregnant females breastfeeding females females who are planning to get pregnant.
- •Known hypersensitivity to minocycline.
- •Any severe systemic illness.
- •Patient already on treatment from last four weeks
- •Grade III acne vulgaris.
结局指标
主要结局
1.Reduction in the numbers of inflammatory lesions total number of inflammatory lesions
时间窗: Total duration of treatment 6 weeks follow up will be done every 2 weeks
will be counted at baseline and at each visit and reduction in these will be calculated by the
时间窗: Total duration of treatment 6 weeks follow up will be done every 2 weeks
formula number of baseline new inflammatory lesions present number of baseline
时间窗: Total duration of treatment 6 weeks follow up will be done every 2 weeks
inflammatory lesions
时间窗: Total duration of treatment 6 weeks follow up will be done every 2 weeks
2.Adverse events patients will be administered adverse effects check list to assess for safety.
时间窗: Total duration of treatment 6 weeks follow up will be done every 2 weeks
次要结局
- 1. Reduction in non-inflammatory lesions(2. Patient self-assessment patients will assess the improvement in acne on a scale of 0 4)
研究者
Monika Chander
Govt Medical College and Hospital Chandigarh