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

Official Title: “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”

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

Intervention(s) in this Clinical Trial

• Drug: YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)
  • 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).
• Drug: Placebo
  • 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)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1
• Placebo Comparator: Arm 2

Primary Measures

• 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.
  • Time Frame: From baseline to Cycle 6.
    Safety Issue?: No

Secondary Measures

• Change from baseline in count of papules
  • Time Frame: Visits 3-5
    Safety Issue?: No
• Change from baseline in count of pustules
  • Time Frame: Visits 3-5
    Safety Issue?: No
• Change from baseline in count of nodules
  • Time Frame: Visits 3-5
    Safety Issue?: No
• Change from baseline in count of open comedones
  • Time Frame: Visits 3-5
    Safety Issue?: No
• Change from baseline in count of closed comedones
  • Time Frame: Visits 3-5
    Safety Issue?: No
• Percentage of subjects classified as "improved" according to the Investigator's Overall Improvement Rating
  • Time Frame: Visits 3-5
    Safety Issue?: No
• Percentage of subjects classifying themselves as "improved" on the Subject's Overall Self-Assessment Rating
  • Time Frame: Visits 3-5
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 14 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Bayer Industry

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00656981

Study ID Number: 91231

ClinicalTrials.gov Identifier: NCT00656981

Health Authority: United States: Food and Drug Administration

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