Evaluate Safety & Efficacy of an Oral Contraceptive (OC) Preparation Versus 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) (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
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
Locations and Contacts
Mobile, Alabama 36608, United States
Kingman, Arizona 86401, United States
Westlake Village, California 91361, United States
Encino, California 91436, United States
San Diego, California 92123, United States
San Diego, California 92103, United States
Denver, Colorado 80246, United States
Castle Rock, Colorado 80108, United States
Palm Springs, Florida 33461, United States
St. Petersburg, Florida 33702, United States
Venice, Florida 34285, United States
Boise, Idaho 83704, United States
Shawnee, Kansas 66203, United States
Louisville, Kentucky 40217, United States
Fridley, Minnesota 55432, United States
East Steauket, New York 11733, United States
New York, New York 10022, United States
Portland, Oregon 97223-6683, United States
Medford, Oregon 97504, United States
Byran, Texas 77801, United States
Arlington, Virginia 22203, United States
Seattle, Washington 98105, United States
Additional Information
Click here and search for drug information provided by the FDA Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product Click here to find results for studies related to marketed products
Starting date: January 2003
Ending date: June 2004
Last updated: May 26, 2008
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