Clinical efficacy of topical fixed dose triple combination of Clindamycin Phosphate, Adapalene and Benzoyl Peroxide in acne vulgaris
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Percentage improvement and reduction in the total lesion count from baseline, and reduction in total lesion count assessed through clinical photography
研究概览
简要总结
This study aims to determine the efficacy of fixed dose triple combination of topical Clindamycin Phosphate 1.2%, Adapalene 0.15%, Benzoyl Peroxide 3.1 % gel in Acne Vulgaris The study will be Prospective, Open label, Single arm interventional study and will be conducted over 18 months at GMCH Chandigarh.
50 patients will be recruited in this study. Patients of acne vulgaris (Grade 1 and Grade 2) and of 12-50 years age will be included in this study. Participants will be instructed to cleanse the facial skin using non medicated gentle soap and water and subsequently apply the designated topical formulation to the affected areas at bedtime. They will be instructed to avoid applying cosmetics, moisturizers, or any other topical treatments on their face.
Clinical evaluation and photographic assessment will be done at baseline first visit and at each follow up visit (3,6,9,12 weeks). The therapeutic response will be evaluated objectively by assessing the total lesion count and calculating the percentage reduction from baseline values. Monitoring and categorization of adverse events will also be done in this study.
A triple drug combination may enhance therapeutic outcomes by acting upon multiple acne-related mechanisms simultaneously and by increasing the compliance of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 12.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of acne vulgaris (Grade 1 and Grade 2) 2)Patients of 12-50 years age.
排除标准
- •Pregnant or lactating women •Patients with signs and symptoms of hyperandrogenism •Patients having hypothyroidism or any other serious systemic illness.
结局指标
主要结局
Percentage improvement and reduction in the total lesion count from baseline, and reduction in total lesion count assessed through clinical photography
时间窗: Assessment will be done at baseline visit (week 0), 3 weeks ,6 weeks , 9 weeks , 12 weeks
次要结局
- 1. Patient-reported outcomes: Evaluation of treatment satisfaction and improvement in acne.(2. Adverse effects: Monitoring and categorization of adverse events in triple combination therapy.)
研究者
Dr Harjot Singh
Government medical college and hospital ,chandigarh