Isolation and Comparative Efficacy of the Combination of beclometasona0, 025% + Gentamicin 0.1% + Clotrimazole 1% Topical Dermatological Cream of GLENMARK PHARMACEUTICALS, in Patients Infected With Acne
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Efficacy of the treatment in patient with infected dermatoses
研究概览
简要总结
The objective of this trial is to evaluate the comparative efficacy of the combination of Clotrimazole + Gentamicin + Beclomethasone in study subjects with a condition of contaminated dermatosis showing bilateral symmetrical lesions.
详细描述
The specific objective is to evaluate, by means of analytical propedeutics medical improvement in clinical signs and symptoms related to acne infected, the use of the association: Clotrimazole, Gentamicin and Beclomethasone versus association: Clotrimazole and Gentamicin, which will first be randomized.
The study should be conducted with 20 research subjects aged over 18 years, of both sexes, showing the framework of bilateral lesions infected with acne, at any stage of evolution. The study subjects will receive treatment with both products, so they can use one in each lesion chosen at random, double-blind.
Thus, the proven efficacy and safety and taking all possible adverse events reported, the study sponsor hopes to obtain registration with the Ministry of Health of this new association in the country.
The association made a proposal was developed by the Laboratory Glenmark Pharmaceuticals Ltd..
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject search of both sexes, regardless of color or social class
- •From age to 18, with good mental health
- •Carriers of two outbreaks of acne contaminated
- •Subjects who agree to return follow-up visits
- •Research subjects who agree to participate and sign the Deed of Consent
排除标准
- •Subject Research carriers of susceptibility to gentamicin
- •Research subjects suffering from sensitivity to clotrimazole
- •Research subjects suffering from sensitivity to beclomethasone
- •Research subjects who are making use of steroids or steroidal anti-inflammatory and non-steroidal drugs or who made use of topical or oral 15 days ago
- •Research subjects who are doing immunosuppressive treatment
- •Research subjects with a diagnosis of eosinophilic folliculitis or Pseudo-folliculitis barbae and groin
- •Pregnant and lactating
研究组 & 干预措施
Treatment with Clotrimazole + Gentamicin + Beclomethasone
干预措施: Clotrimazole + Gentamicin + Beclomethasone (Drug)
Treatment with Clotrimazole + Gentamicin
干预措施: Clotrimazole + Gentamicin (Drug)
结局指标
主要结局
Efficacy of the treatment in patient with infected dermatoses
时间窗: 21 days of treatment
次要结局
- evaluate the safety and tolerability of both formulations in the course of treatmen(21 days of treatment)
研究者
Azidus Brasil
Principal Investigator Dr. Alexandre Frederico
Azidus Brasil