Trial Condition(s):
Acne vulgaris
Evaluate Safety and Efficacy of an OC Preparation vs placebo for 6 Treatment Cycles in Women with Moderate Acne.
Bayer Identifier:
91209
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 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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Radiant Research - Birmingham Birmingham, United States, 35209 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations nTouch Research Houston, United States, 77024 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medical Center for Clinical Research San Diego, United States, 92108 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Piedmont Medical Research Associates Inc. Winston-Salem, United States, 27103 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Washington Hospital Center Washington, United States, 20010-2975 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Desert Clinical Research Mesa, United States, 85201 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Penn State Milton S. Hershey Medical Center Hershey, United States, 17033-0850 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Academic Dermatology Associates Albuquerque, United States, 87106 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations FXM Research Miami, United States, 33175 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Boston Clinical Research Center Wellesley, United States, 02481 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Impact Clinical Trials Los Angeles, United States, 90010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medical Affiliated Research Center Huntsville, United States, 35801 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Texas Dermatology Research Institute Dallas, United States, 75230 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dermatology Clinical Research Center San Antonio, United States, 78229 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wake Forest University School of Medicine Winston-Salem, United States, 27157 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Omega Medical Research Warwick, United States, 02886 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations DermResearch, Inc. Austin, United States, 78759 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dermatology Research Associates, Inc. Cincinnati, United States, 45230 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Compliant Clinical Research Inc. Kansas City, United States, 64114 | 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 Advanced Clinical Research Boise, United States, 83704 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations nTouch Research Houston, United States, 77024 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Philadelphia Clinical Research Philadelphia, United States, 19114 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Insignia Care for Women, P.A. Tampa, United States, 33607 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Women's Center for Clinical Research New Orleans, United States, 70115 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Physicians Research Group Indianapolis, United States, 46250 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. John Lenihan, MD Tacoma, United States, 98405 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Peryam & Kroll Healthcare Research Chicago, United States, 60631 | 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
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