To compare the efficacy and safety of Topical Minocycline 4percent Gel versus Topical Clindamycin 1percent Gel in combination with benzoyl peroxide 2.5percent gel in patients of moderate to severe Acne Vulgaris. A Randomized active controlled open label study.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- A. Primary objective
研究概览
简要总结
1. Acne vulgaris is a chronic inflammatory disease of the pilosebaceous unit characterized by open or closed comedones (non-inflammatory), papules, pustules, nodules (inflammatory) on the face or trunk and may result in pain, erythema, hyperpigmentation or scars. It is one of the most common skin disorders worldwide, with an estimated global prevalence of 9.38%.1 As per Global burden of diseases study, acne affects approximately 85% of young adults.2 In India, acne is prevalent in 72.3% of adolescents and 27% of the adult age group.3Acne can be associated with poor quality of life leading to depression and anxiety. As per recent International guidelines, American academy of dermatology limits the use of systemic antibiotic use when possible to reduce the development of antibiotic resistance and other systemic side effects related to autoimmune reactions and gastrointestinal problems.4 The guidelines strongly suggest the use of topical antibiotics in combination with benzoyl peroxide to prevent development of resistance. Both topical minocycline and clindamycin are US FDA (Food and Drug Administration) approved for use in acne. However, there are very few studies in literature to compare the efficacy of topical antibiotics in moderate to severe acne vulgaris. Therefore, our study aim will be to compare the efficacy and safety of topical Minocycline 4% Gel with topical Clindamycin 1% Gel in combination with benzoyl peroxide 2.5% gel in patients of moderate to severe Acne Vulgaris.
2. Hypothesis: Topical minocycline 4% gel in combination with benzoyl peroxide 2.5% is non inferior to topical clindamycin 1 % gel with benzoyl peroxide 2.5% in patients of moderate to severe acne vulgaris.
3. Research questions: Is topical minocycline 4% gel in combination with benzoyl peroxide 2.5% inot less efficacious than topical clindamycin 1 % gel with benzoyl peroxide 2.5% in patients of moderate to severe acne vulgaris?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 9.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female individuals age 9 years and above.
- •Patients having acne vulgaris of moderate-to-severe facial acne, as defined by an Investigator’s Global Assessment (IGA) score of 3 or 4 and lesion counts of 20 to 50 inflammatory lesions (papules, pustules, and nodules), 25 to 100 noninflammatory lesions (open and closed comedone) Providing signed consent forms after understanding the written contents outlining the requirements of participating in the study.
排除标准
- •Female subjects who are pregnant, lactating, or planning to become pregnant.
- •Use of oral retinoids or corticosteroids within 12 weeks Use of topical retinoids, topical anti-inflammatory drugs and corticosteroids, oral antibiotics, or other systemic acne treatment within 4 weeks • Patients with concomitant other skin diseases like psoriasis or urticaria.
结局指标
主要结局
A. Primary objective
时间窗: 3 weekly till 12 weeks
1. The number of patients who achieved IGA-assessed treatment success in each group, i.e IGA score of 0 or 1(description of clear or almost clear) plus at least a 2-grade improvement from baseline.
时间窗: 3 weekly till 12 weeks
2. To evaluate the change in absolute count of inflammatory and non-inflammatory lesions from baseline to the end of the study.
时间窗: 3 weekly till 12 weeks
次要结局
- B. Secondary objective(1. To compare the IGA score and absolute inflammatory and non-inflammatory lesions between the two groups A and B in each visit.)
研究者
Dr Yashdeep Singh Pathania
AIIMS Rajkot