临床试验/NCT00656981

NCT00656981已完成3 期

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety & Efficacy of Oral Contraceptive Prep., Containing Drospirenone 3 mg/Ethinyl Estradiol 20 Mcg for 6 Treatment Cycles in Women With Moderate Acne Vulgaris

Bayer0 个研究点目标入组 541 人开始时间: 2003年1月最近更新: 2014年12月30日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Bayer
入组人数: 541
主要终点: Percent change in inflammatory lesion counts (including papules, pustules, and nodules), non-inflammatory lesion counts (including open and closed comedones), total lesion count, and the ISGA.

研究概览研究设计入排标准研究组 & 干预措施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

The objectives of this study were to evaluate the efficacy and safety of drospirenone 3 mg/ethinyl estradiol 0.02 mg (DRSP/EE) in comparison with placebo in female subjects with moderate acne vulgaris during 6 treatment cycles

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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 14 Years 至 45 Years（Child, Adult）
性别: Female
接受健康志愿者: 是

入选标准

•Female age 14-45, with 10 to 100 comedones (noninflammatory lesions), 10 to 50 inflammatory lesions (papules or pustules), and not more than 35 nodules (<5mm) on the face).

排除标准

•Standard contraindications for use of combined oral contraceptives (class label)plus
•Subjects with acne and atopia, comedonal acne or acne conglobate, sandpaper acne or acne with multiple large nodes, cysts, fistular comedones, or abscessing fistular ducts
•Use of comedogenic covering cream, comedogenic sunscreens, other sex hormone preparations or any other anti-acne therapy (eg, light therapy, oleic acids, chemical peelings, mechanical extraction of comedones)
•Acne therapy with sex hormone preparations given over 3 months or longer and proved to be unsuccessful
•Preparations that have had an acne-inducing effect, eg, iodinated or bromated drugs, tuberculostatics, lithium, Vitamin B1, B6, B12, D3, corticoids, ACTH, anabolics, quinine, disulfiram, methoxypsoralen, phenobarbital, phenytoin, trimethadione, thyroid depressants, and certain oily cosmetics

研究组 & 干预措施

Arm 1

Experimental

干预措施: YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300) (Drug)

Arm 2

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Percent change in inflammatory lesion counts (including papules, pustules, and nodules), non-inflammatory lesion counts (including open and closed comedones), total lesion count, and the ISGA.

时间窗: From baseline to Cycle 6.

次要结局

Change from baseline in count of closed comedones(Visits 3-5)
Change from baseline in count of papules(Visits 3-5)
Change from baseline in count of pustules(Visits 3-5)
Change from baseline in count of nodules(Visits 3-5)
Change from baseline in count of open comedones(Visits 3-5)
Percentage of subjects classified as "improved" according to the Investigator's Overall Improvement Rating(Visits 3-5)
Percentage of subjects classifying themselves as "improved" on the Subject's Overall Self-Assessment Rating(Visits 3-5)

研究者

发起方

Bayer

申办方类型

Industry

责任方

Sponsor

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