Comparative study of efficacy, safety and cost effectiveness of Minocycline 4 percent gel and Adapalene 0.1 percent plus Benzoyl peroxide 2.5 percent combination gel in mild to moderate facial Acne vulgaris. A prospective, randomized, open labelled parallel study.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The mean reduction in GAGS score from baseline to week 8 in each treatment regimen group will be the primary outcome of the study
研究概览
简要总结
Acne vulgaris is a chronic inflammatory skin condition with significant psychosocial impact, requiring effective and well-tolerated treatment especially in a developing country like India. This study would provide valuable data of the first head to head comparison of the efficacy, safety, and cost-effectiveness of minocycline 4% gel and adapalene 0.1%–benzoyl peroxide 2.5% gel in mild to moderate cases. Conducted at AIIMS Nagpur with 80 patients in a randomized, open-label design, it assesses outcomes over eight weeks. The study findings will aid clinical decision-making, optimizing treatment protocols and potentially reducing reliance on systemic therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 12.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either gender aged between 12 and 40 years, suffering from mild to moderate facial acne vulgaris, having a GAGS score less than or equal to 30, willing to give written informed consent who had not taken topical antiacne medications in last 14 days and, systemic medications in last 30 days will be included in this study.
排除标准
- •Patients already on topical anti-acne medication for 14 days, use of systemic therapy within last 30 days before inclusion into the study, patients with a dermatological condition of the face that could interfere with the clinical evaluations, such as sunburn, psoriasis, seborrheic dermatitis, or eczema, patients who were on oral contraceptive pills in the last 12 weeks, patients unwilling to give written informed consent, Individuals with secondary acne, such as occupational acne or drug induced acne, patients who have known hypersensitivity to adapalene, minocycline, benzoyl peroxide or any ingredient of the study drug, Pregnant or lactating women and the patients who the investigator deemed to be unsuitable for any reason will be excluded from the study.
结局指标
主要结局
The mean reduction in GAGS score from baseline to week 8 in each treatment regimen group will be the primary outcome of the study
时间窗: 8 weeks
次要结局
- The Cost effectiveness ratio of each treatment regimen by calculating the Average and Incremental Cost Effectiveness Ratio by the end of 8 weeks will be a secondary outcome of this study(8 weeks)
- Number of adverse events in each treatment regimen group as reported by patients or observed by investigator over the duration of 8 weeks of treatment will be secondary outcome of this study(0 to 8 weeks)