A prospective randomized open label study to compare the efficacy and tolerability of topical clindamycin 1% with and without topical benzoyl peroxide 2.5 percent in mild to moderate cases of acne.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 358
- 试验地点
- 1
研究概览
简要总结
This is a prospective randomized open-label comparative study conducted at the Department of Dermatology, Kempegowda Institute of Medical Sciences, Bangalore. The study compares the efficacy and tolerability of topical clindamycin 1 percent gel alone versus topical clindamycin 1 percent gel combined with benzoyl peroxide 2.5 percent gel in treating mild to moderate acne vulgaris. Participants will be randomly assigned to two treatment groups. Group C will receive topical clindamycin 1 percent gel twice daily. Group B will receive topical clindamycin 1 percent gel twice daily plus benzoyl peroxide 2.5 percent gel once daily at night. Treatment duration is 3 months with monthly clinical evaluations to assess acne severity using the Investigators Global Assessment scale, efficacy, and tolerability. The study includes comprehensive informed consent forms in English and Kannada, participant information sheets, assent forms for minors, consent forms for medical photography, and detailed case record forms for systematic data collection. All participants will be monitored for common side effects including dryness, redness, burning sensation, itching, peeling, and irritation at the application site.
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
- 14.00 Year(s) 至 40.00 Year(s)(—)
- 性别
- All
入选标准
- •Individuals of either gender aged 14 to 40 years.
- •Clinically diagnosed with mild to moderate acne vulgaris.
- •Investigator Global Assessment score of 2 or
- •Willing to provide written informed consent and adhere to study protocol and follow up visits.
排除标准
- •Use of any topical or systemic medication for the treatment of acne vulgaris within the preceding one month.
- •Presence of severe inflammatory acne such as nodulocystic acne.
- •Known hypersensitivity to any of the study medications including benzoyl peroxide or clindamycin.
- •Pregnant or lactating women.
- •History of use of corticosteroids, anti tubercular therapy or anti epileptic drugs.
- •Underlying medical conditions including polycystic ovarian disease or hepatic impairment.
研究者
Dr Simran Thory
kempegowda institute of medical sciences
