A prospective, randomised, open label, parallel group, comparative study of efficacy and tolerability of Oral Azithromycin versus Oral Doxycycline with topical Clindamycin in subjects with grade 2 and grade 3 Acne Vulgaris
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess and compare the efficacy and tolerability of oral Azithromycin and oral Doxycycline in subjects with grade 2 and 3 acne vulgaris
研究概览
简要总结
Acne vulgaris is a chronic inflammatory disease of the pilosebaceous follicles, characterized by comedones, papules, pustules, nodules and often scars.Acne is commonly encountered in adolescents and young adults.Even though acne vulgaris donot cause any mortality but often there is significant physical and psychological morbidity like permanent scarring,poor self image,depression and anxiety as it commonly effects the face,back and chest.Therefore, early and effective treatment of acne lesions is vital to prevent facial scars that lead to cosmetic and psychological impact on the subjects.Inspite of the availability of various therapies,standard guidelines and recommendations, the outcome of these therapies are still unsatisfactory with regard to efficacy,tolerability,safety,adverse effects and bacterial resistance.There are a few studies comparing efficacy and tolerability of pulsed oral azithromycin and doxycycline with topical clindamycin in Indian population and hence the present study is taken.
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
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- All
入选标准
- •Willingness to give written informed consent and availability for regular followup.
- •Subjects with Acne Vulgaris of grade 2 and 3 as per the investigators global assessment scale.
- •Subjects must be willing to refrain from using all other topical Acne medications or antibiotics during the 8 week treatment period.
排除标准
- •Subjects with severe acne, nodulocystic lesions, acne conglobate, acne fulminans, acne rosacea, secondary(drug induced) acne.ion ingestion.
- •Subjects with a history of hypersensitivity or allergy to any study medication ingredients.
- •Subjects who have participated in any investigational drug study within 30 days prior to baseline will be excluded from participation.
- •Female subjects who are pregnant,lactating or planning to become pregnant during study participation.
结局指标
主要结局
To assess and compare the efficacy and tolerability of oral Azithromycin and oral Doxycycline in subjects with grade 2 and 3 acne vulgaris
时间窗: 8 weeks
次要结局
- Quality of life will be assessed using DLQI score(8 weeks)