Evaluate Safety and Efficacy of an Oral Contraceptive (OC) Preparation Versus 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: NCT00656981
• 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: 2004-06
• Study First Submitted: 2008-04-09
• Study First Submitted QC: 2008-04-11
• Study First Posted: 2008-04-14
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-29
• Last Update Posted: 2014-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 541

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 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

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 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
Change from baseline in count of closed 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