Evaluate Safety and Efficacy of an Oral Contraceptive (OC) Preparation Versus Placebo for 6 Treatment Cycles in Women With Moderate Acne

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)<br>* The study medication was packaged in 28-tablet blister packs. Each subject kit contained 6 blister packs plus 1 reserve blister pack.Subjects randomly assigned to the active treatment group received 24 consecutive days of hormonally active tablets (3mgDRSP/0.02mgEE) followed by 4 consecutive days of inactive tablets. The treatment period was 6 cycles (28 tablets per cycle).<br>|
| Placebo Comparator: Arm 2<br> | Drug: Placebo<br>* The subjects randomly assigned to the placebo group received 28 inert but identical-appearing, color-matched tablets. The treatment period was 6 cycles (28 tablets per cycle)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acne, Moderate Acne Vulgaris