Evaluate Safety & Efficacy of an OC Preparation vs Placebo for 6 Treatment Cycles in Women With Moderate Acne
Information source: Bayer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acne Vulgaris
Intervention: YAZ (DRSP 3 mg/EE 0.02 mg (as Beta-Cyclodextrin Clathrate)) (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
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 during 6 treatment cycles.
Clinical Details
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.
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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.
Secondary outcome: Change from baseline in count of papulesChange from baseline in count of pustules Change from baseline in count of nodules Change from baseline in count of open comedones Change from baseline in count of closed comedones Percentage of subjects classified as "improved" according to the Investigator's Overall Improvement Rating Percentage of subjects classifying themselves as "improved" on the Subject's Overall Self-Assessment Rating
Eligibility
Minimum age: 14 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Birmingham, Alabama 35209, United States
Huntsville, Alabama 35801, United States
Mesa, Arizona 85201, United States
San Diego, California 92108, United States
Los Angeles, California 90010, United States
Washington, District of Columbia 20010-6889, United States
St. Petersburg, Florida 33702, United States
Miami, Florida 33175, United States
Tampa, Florida 33607, United States
Boise, Idaho 83704, United States
Indianapolis, Indiana 46250, United States
New Orleans, Louisiana 70115, United States
Kansas City, Missouri 64114, United States
Albuquerque, New Mexico 87106, United States
Winston-Salem, North Carolina 27157-1048, United States
Winston-Salem, North Carolina 27103, United States
Cincinnati, Ohio 45230, United States
Philadelphia, Pennsylvania 19114, United States
Hershey, Pennsylvania 17033, United States
Warwick, Rhode Island 02886, United States
Dallas, Texas 75230, United States
San Antonio, Texas 78229, United States
Austin, Texas 78759, United States
Houston, Texas 77024, United States
Tacoma, Washington 98405, United States
Additional Information
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Starting date: January 2003
Ending date: July 2004
Last updated: May 26, 2008
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