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

Completed · Phase 3 · Has a placebo group

Conditions studied: Acne Vulgaris

In brief

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.

Key facts

Study ID

NCT00651469

Run by

Bayer

People needed

534

Starts

2003-01-01

Expected to finish

2004-07-01

Last updated by the study team

2014-12-30

Who can join

Age: 14 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Huntsville, Alabama, United States
• Study site — Mesa, Arizona, United States
• Study site — Los Angeles, California, United States
• Study site — San Diego, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Miami, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Boise, Idaho, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Wellesley, Massachusetts, United States
• Study site — Kansas City, Missouri, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Hershey, Pennsylvania, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Warwick, Rhode Island, United States
• Study site — Austin, Texas, United States
• Study site — Dallas, Texas, United States
• Study site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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