Phase IV Clinical Study Of Clindamycin Phosphate Topical Gel In The Treatment Of Acne Vulgaris

Pfizer0 个研究点目标入组 134 人开始时间: 2005年1月最近更新: 2011年5月11日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方: Pfizer
入组人数: 134
主要终点: To verify the non-inferiority to Acuatim cream of Dalacin T Gel in terms of the percent reduction in the inflammatory lesion count (the assessments of investigator) at Treatment Week 4 or EOT (discontinuation)

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

To investigate, in a comparison vs. Acuatim cream (nadifloxacin cream), the efficacy and safety of Dalacin T Gel (clindamycin phosphate gel) as a therapeutic medication for acne vulgaris in acne vulgaris patients, including children ages 13 and up, in order to clarify the clinical positioning of Dalacin T Gel.

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

入排标准

年龄范围: 13 Years 至 35 Years（Child, Adult）
性别: All
接受健康志愿者: 否

入选标准

•Acne vulgaris patients found by a investigator to have at least 10 inflammatory lesions (papules, pustules) on a portion of either a cheeks or the forehead, with an inflammation severity of moderate or worse.

排除标准

•Patients with, for example, acne elastosis, steroidal acne, necrotizing acne, or occupational acne.

结局指标

主要结局

To verify the non-inferiority to Acuatim cream of Dalacin T Gel in terms of the percent reduction in the inflammatory lesion count (the assessments of investigator) at Treatment Week 4 or EOT (discontinuation)

次要结局

To verify the non-inferiority to Acuatim cream of Dalacin T Gel in terms of the percent reduction in the inflammatory lesion count (the assessments of the Data Review Committee based on photographs) at Treatment Week 4 or EOT (discontinuation) According

研究者

发起方

Pfizer

申办方类型

Industry

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