Evaluate Safety and Efficacy of an OC Preparation vs Placebo for 6 Treatment Cycles in Women With Moderate Acne.

Phase 3

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300); Drug: Placebo

• Registration Number: NCT00651469
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Study Completion: 2004-07
• Study First Submitted: 2008-03-31
• Study First Submitted QC: 2008-04-01
• Study First Posted: 2008-04-02
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-29
• Last Update Posted: 2014-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 534

Inclusion Criteria

• 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).

Exclusion Criteria

• 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 pellings, 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)	-
Arm 2	Placebo	-

Primary Outcome Measures

Name	Time	Method
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.	From baseline to Cycle 6

Secondary Outcome Measures

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