Status:
COMPLETED
Evaluate Safety and Efficacy of an Oral Contraceptive (OC) Preparation Versus Placebo for 6 Treatment Cycles in Women With Moderate Acne
Lead Sponsor:
Bayer
Conditions:
Acne Vulgaris
Eligibility:
FEMALE
14-45 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2004
Estimated Enrollment :
541 Patients enrolled
Trial Details
Trial ID
NCT00656981
Start Date
January 1 2003
End Date
June 1 2004
Last Update
December 30 2014
Active Locations (22)
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1
Mobile, Alabama, United States, 36608
2
Kingman, Arizona, United States, 86401
3
Encino, California, United States, 91436
4
San Diego, California, United States, 92103