Superior Efficacy of Azithromycin and Levamisole Versus of Azithromycin Alone in the Treatment of Inflammatory Acne Vulgaris: An Investigator Blind Randomized Clinical Trial on 169 Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 169
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events
研究概览
简要总结
Different immunologic mechanisms contribute to development of inflammation in acne vulgaris and immunologic effect of levamisole has been demonstrated.
Objective: The aim of this study was to compare azithromycin and levamisole with azithromycin alone in the treatment of acne vulgaris.
详细描述
An investigator blind clinical randomized prospective two months study was designed. One hundred sixty nine acne patients presenting in our outpatients clinic were randomly allocated to two treatment groups: azithromycin and levamisole ( group 1 ) and azithromycin alone ( group 2 ) .One hundred forty eight patients completed the duration of the study and their clinical responses were evaluated and compared by using monthly photographic records .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who had at least 20 papules and/or pustules,
- •Patients with nodule and/or cyst disregarding the number of papules of pustules, were included the study. There was not any age limit
排除标准
- •were using any type of systemic treatment for their acne at the time of visit or during the last month;
- •had any hematological, renal or hepatic disease
- •were pregnant or lactating;
- •had drug-induced acne;
- •were using alcohol, anti-convulsants or anti-coagulants.
研究组 & 干预措施
Azithromicine plus levamisole
干预措施: Levamisole (Drug)
Azithromicin
干预措施: Levamisole (Drug)
结局指标
主要结局
Number of Participants with Adverse Events
时间窗: one year
A questionnaire was filled for every patient.For patients in both groups, lab tests were done at each visit.All adverse effect and the number of them were recorded and the patients who had side-effects or didn't follow the visits were excluded from the study.
次要结局
未报告次要终点