Trial Condition(s):
Acne vulgaris
Evaluate Safety and Efficacy of an Oral Contraceptive (OC) Preparation versus Placebo for 6 Treatment Cycles in Women with Moderate Acne
Bayer Identifier:
91231
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Visions Clinical Research Palm Springs, United States, 33461 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Stony Brook Dermatology Assoc. East Steauket, United States, 11733 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Comprehensive NeuroScience, Inc. St. Petersburg, United States, 33702 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cherry Creek Research, Inc. Denver, United States, 80246 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oregon Medical Research Center Portland, United States, 97223-6683 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Westlake Medical Research Westlake Village, United States, 91361 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Compliant Clinical Research, Inc. Shawnee, United States, 66203 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. T. Joseph Raoof, M.D. Inc. Encino, United States, 91436 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Women's Health Care, Inc. San Diego, United States, 92123 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sloane Hospital for Women New York, United States, 10022 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Trial Center of Colorado Castle Rock, United States, 80108 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Women's Clinical Research Center Seattle, United States, 98105 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Genesis Center for Clinical Research San Diego, United States, 92103 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations OB/GYN Health Center Medford, United States, 97504 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Arizona Desert Dermatology Kingman, United States, 86401 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Advanced Clinical Research Boise, United States, 83704 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations J & S Studies, Inc. Byran, United States, 77801 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Minnesota Clinical Study Center Fridley, United States, 55432 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Millennium Clinical Research Center Arlington, United States, 22203 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Coastal Clinical Research, Inc Mobile, United States, 36608 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Robert Semo, MD Venice, United States, 34285 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Physician's Skin Care Louisville, United States, 40217 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- 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.Timeframe: From baseline to Cycle 6.
Secondary Outcome
- Change from baseline in count of papulesTimeframe: Visits 3-5
- Change from baseline in count of pustulesTimeframe: Visits 3-5
- Change from baseline in count of nodulesTimeframe: Visits 3-5
- Change from baseline in count of open comedonesTimeframe: Visits 3-5
- Change from baseline in count of closed comedonesTimeframe: Visits 3-5
- Percentage of subjects classified as "improved" according to the Investigator's Overall Improvement RatingTimeframe: Visits 3-5
- Percentage of subjects classifying themselves as "improved" on the Subject's Overall Self-Assessment RatingTimeframe: Visits 3-5
Additional Information
Copyright © Bayer
Powered by
