A study of The efficacy and safety profile of topical Clindamycin 1% gel versus topical Minocycline 4% gel versus topical Ozenoxacin 1% cream in the treatment of Acne Vulgaris, a triple arm randomized controlled trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- number of total lesion count, seperating the inflammatory and non-inflammatory lesions, evaluators global acne severity score, investigators global assessment score, patients assessment score
研究概览
简要总结
The patients meeting the inclusion criteria shall be considered to participate in the study
A detailed history including the duration of the disease, associated medical conditions to be taken.
The patients are randomized and allocated to the three interventional groups
One group will be given topical Clindamycin 1% gel to be applied locally twice daily
The second group will be given topical Minocycline 4% gel, to be applied locally once daily
The third group will be given topical Ozenoxacin 1% cream, to be applied topically twice daily
Follow up is done at 4weeks, 8weeks and 12 weeks
To assess the outcome, the no. of total and each type of acne lesions(non inflammatory and inflammatory) are counted, Evaluator’s global acne severity score and Investigator’s global assessment score(IGA) scores are calculated at the initial visit and at each follow up
To assess the adverse effects, any reaction or peeling/desquamation, stinging, burning, redness/erythema, and itching/pruritis in lesions are duly noted
Clinical images will be taken at the starting of the therapy and in each follow up to look for the improvement
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 14.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients with Mild papulopustular Acne fairly localized inflamed and non-inflamed lesions, superficial inflammatory lesions being less than 5mm in diameter according to European evidence based S3 acne guidelines.
排除标准
- •Patients with mild comedonal acne Patients with moderate or severe acne Patients who have been regularly using anti acne medications since the last 30 days Patients with acne conglobate, acne fulminans or drug-induced acne Patients with history of hypersensitivity to clindamycin, minocycline or ozenoxacin Patients who are unwilling or unable to comply with the study proceedings to give written, informed consent Pregnant or lactating women Patients with history of photosensitivity Hormonal or endocrine or autoimmune abnormality Topical Steroid Dependent Face.
结局指标
主要结局
number of total lesion count, seperating the inflammatory and non-inflammatory lesions, evaluators global acne severity score, investigators global assessment score, patients assessment score
时间窗: every monthly for 3 months
次要结局
- presence of scaling, erythema, burning, itching, stinging(every monthly for 3 months)
研究者
Parul Bansal
IMS and Sum Hospital