Evaluate Safety and Efficacy of an Oral Contraceptive (OC) Preparation Versus Placebo for 6 Treatment Cycles in Women With Moderate Acne
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
2 other identifiers
interventional
541
1 country
22
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 during 6 treatment cycles
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2003
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
April 9, 2008
CompletedFirst Posted
Study publicly available on registry
April 14, 2008
CompletedDecember 30, 2014
December 1, 2014
April 9, 2008
December 29, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
From baseline to Cycle 6.
Secondary Outcomes (7)
Change from baseline in count of papules
Visits 3-5
Change from baseline in count of pustules
Visits 3-5
Change from baseline in count of nodules
Visits 3-5
Change from baseline in count of open comedones
Visits 3-5
Change from baseline in count of closed comedones
Visits 3-5
- +2 more secondary outcomes
Study Arms (2)
Arm 1
EXPERIMENTALArm 2
PLACEBO COMPARATORInterventions
The study medication was packaged in 28-tablet blister packs. Each subject kit contained 6 blister packs plus 1 reserve blister pack.Subjects randomly assigned to the active treatment group received 24 consecutive days of hormonally active tablets (3mgDRSP/0.02mgEE) followed by 4 consecutive days of inactive tablets. The treatment period was 6 cycles (28 tablets per cycle).
The subjects randomly assigned to the placebo group received 28 inert but identical-appearing, color-matched tablets. The treatment period was 6 cycles (28 tablets per cycle)
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (22)
Unknown Facility
Mobile, Alabama, 36608, United States
Unknown Facility
Kingman, Arizona, 86401, United States
Unknown Facility
Encino, California, 91436, United States
Unknown Facility
San Diego, California, 92103, United States
Unknown Facility
San Diego, California, 92123, United States
Unknown Facility
Westlake Village, California, 91361, United States
Unknown Facility
Castle Rock, Colorado, 80108, United States
Unknown Facility
Denver, Colorado, 80246, United States
Unknown Facility
Palm Springs, Florida, 33461, United States
Unknown Facility
St. Petersburg, Florida, 33702, United States
Unknown Facility
Venice, Florida, 34285, United States
Unknown Facility
Boise, Idaho, 83704, United States
Unknown Facility
Shawnee, Kansas, 66203, United States
Unknown Facility
Louisville, Kentucky, 40217, United States
Unknown Facility
Fridley, Minnesota, 55432, United States
Unknown Facility
East Steauket, New York, 11733, United States
Unknown Facility
New York, New York, 10022, United States
Unknown Facility
Medford, Oregon, 97504, United States
Unknown Facility
Portland, Oregon, 97223-6683, United States
Unknown Facility
Byran, Texas, 77801, United States
Unknown Facility
Arlington, Virginia, 22203, United States
Unknown Facility
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2008
First Posted
April 14, 2008
Study Start
January 1, 2003
Study Completion
June 1, 2004
Last Updated
December 30, 2014
Record last verified: 2014-12