A prospective comparative randomized open label tri arm study on efficacy and tolerability of topical 2.5 percent benzoyl peroxide gel vs 1 percent clindamycin gel vs 4 percent minocycline gelin patient with acne grade II & III
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 303
- 试验地点
- 1
- 主要终点
- Compar efficacy of therapy with respect to decrease in number of lesions
研究概览
简要总结
Acne is common cutaneous, inflammatory disease of pilosebaceous unit which runs chronic course. Acne can be psychologically devastating, causing psychological stress and embarrassment.
Various treatment options include topical and oral medications, procedures.
This randomized, prospective study aim to compare efficacy and safety of topical antibiotics in treatment of acne.
Study will be conducted in tertiary care set up. Patients enrolled will be divided into 3 groups. Group A will receive benzoyl peroxide gel.
Group B will recieve clindamycin gel. Group C will receive minocycline gel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •All adult patients diagnosed with acne vulgaris grade II & III.
排除标准
- •Patient unwilling to give consent to be part of trial.
- •Pregnant, lactating female and patients planning pregnancy during trial period.
- •Patient with nodulocystic lesion, acne conglobata, acne fulminans, secondary acne, acne excoriata (e.g. chloracne, drug induced acne) or any other acne requiring systemic treatment.
- •People suffering from photosensitivity disorders.
- •Clinically significant hepatic impairement.
- •History of DRESS syndrome, serum sickness, vasculitis.
- •History of hypersensitivity to benzoyl peroxide, clindamycin, minocycline.
结局指标
主要结局
Compar efficacy of therapy with respect to decrease in number of lesions
时间窗: Calculation of Global Acne Grading score. | Assessment of clinical photographs by blinded physician by percentage response scale. | Patient satisfaction measured according to 5 point liker scale. | Measured at baseline, 4 week, 8 weeks, 12 weeks and 3 months post treatment.
次要结局
- Analyse the safety & tolerability of different antibiotics benzoyl peroxide vs clindamycin vs minocycline with respect to adverse effect related to therapy(Compared at baseline,during course of therapy at 4 week, 8week, 12week & end of post treatment follow up period I.e.after 3 month.)
研究者
Jyotsana Naikwadi
Shri Bhausaheb Hire Government Medical College Dhule