NCT01260571Unknown4 期
Clinical Study to Evaluate the Efficacy of Topical Medications Containing Benzoyl Peroxide and Sulfur in the Regression in the Short Time (24 Hours) of Moderate Acne Vulgaris Grade II (Pimples)
Zurita Laboratorio Farmaceutico Ltda.1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2011年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Clinical study to evaluate the efficacy of topical medications containing benzoyl peroxide and sulfur in the regression in the short time (24 hours) of moderate acne vulgaris grade II (pimples).
研究概览
简要总结
Sixty two subjects will take part in this study. The study is unic arm. The subjects used the product once and will be evaluated in the regression of pimples in the times 0,4,6,8 and 24 hours after application.
A follow-up visit will be made 24 hours after initiation of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 12 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of both sexes aged to 12 years to 35 years
- •Oily skin prone to acne
- •Presence of at least three inflammatory lesions, diagnosed as grade II acne vulgaris.
- •Sign the informed Consent Form
- •Comply the requirements and attend to study visits
排除标准
- •Pregnancy (need for urinary pregnancy test for women of childbearing age)
- •Lactation
- •Presence of acne conglobata and nodulocystic
- •Pathologies associated hormonal (thyroid diseases, ovaries micropolycystic)
- •Drug use systemic corticosteroids, anticonvulsants and / or new drugs for up to one month before to selection.
- •History of atopy or allergic cutaneous
- •History of hypersensitivity to benzoyl peroxide and sulfur
- •Beginning or ending the use of contraceptives (for females)
- •Intense sun exposure until one month before the evaluation
研究组 & 干预措施
Benzoyl Peroxide and Sulfur
Experimental
Topical Medications containing benzoyl peroxide and sulfur
干预措施: Benzoyl peroxide and sulfur (Drug)
结局指标
主要结局
Clinical study to evaluate the efficacy of topical medications containing benzoyl peroxide and sulfur in the regression in the short time (24 hours) of moderate acne vulgaris grade II (pimples).
时间窗: 24 hours
Clinical evolution of the target lesions for each experimental time regarding the parameters of reddening, size and general appearance of the lesion.
次要结局
未报告次要终点
研究者
研究点 (1)
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