Study Completed

Acne Vulgaris

Bayer Identifier:

91231

ClinicalTrials.gov Identifier:

NCT00656981

EudraCT Number:

Not Available

EU CT Number:

Not Available

Evaluate Safety and Efficacy of an Oral Contraceptive (OC) Preparation versus Placebo for 6 Treatment Cycles in Women with Moderate Acne

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

Key Participants Requirements

Sex

Female

Age

14 - 45 Years

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

541

Trial Dates

January 2003 - June 2004

Phase

Phase 3

Could I Receive a placebo

Yes

Products

YAZ (EE20/DRSP, BAY86-5300)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed	Visions Clinical Research	Palm Springs, 33461, United States
Completed	Stony Brook Dermatology Assoc.	East Steauket, 11733, United States
Completed	Comprehensive NeuroScience, Inc.	St. Petersburg, 33702, United States
Completed	Cherry Creek Research, Inc.	Denver, 80246, United States
Completed	Oregon Medical Research Center	Portland, 97223-6683, United States
Completed	Westlake Medical Research	Westlake Village, 91361, United States
Completed	Compliant Clinical Research, Inc.	Shawnee, 66203, United States
Completed	Dr. T. Joseph Raoof, M.D. Inc.	Encino, 91436, United States
Completed	Women's Health Care, Inc.	San Diego, 92123, United States
Completed	Sloane Hospital for Women	New York, 10022, United States
Completed	Clinical Trial Center of Colorado	Castle Rock, 80108, United States
Completed	Women's Clinical Research Center	Seattle, 98105, United States
Completed	Genesis Center for Clinical Research	San Diego, 92103, United States
Completed	OB/GYN Health Center	Medford, 97504, United States
Completed	Arizona Desert Dermatology	Kingman, 86401, United States
Completed	Comprehensive NeuroScience, Inc.	St. Petersburg, 33702, United States
Completed	Advanced Clinical Research	Boise, 83704, United States
Completed	J & S Studies, Inc.	Byran, 77801, United States
Completed	Minnesota Clinical Study Center	Fridley, 55432, United States
Completed	Millennium Clinical Research Center	Arlington, 22203, United States
Completed	Coastal Clinical Research, Inc	Mobile, 36608, United States
Completed	Dr. Robert Semo, MD	Venice, 34285, United States
Completed	Physician's Skin Care	Louisville, 40217, United States

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.
Time Frame:
From baseline to Cycle 6.
Safety Issue:
no

Secondary Outcome

Change from baseline in count of papules
Time Frame:
Visits 3-5
Safety Issue:
no
Change from baseline in count of pustules
Time Frame:
Visits 3-5
Safety Issue:
no
Change from baseline in count of nodules
Time Frame:
Visits 3-5
Safety Issue:
no
Change from baseline in count of open comedones
Time Frame:
Visits 3-5
Safety Issue:
no
Change from baseline in count of closed comedones
Time Frame:
Visits 3-5
Safety Issue:
no
Percentage of subjects classified as "improved" according to the Investigator's Overall Improvement Rating
Time Frame:
Visits 3-5
Safety Issue:
no
Percentage of subjects classifying themselves as "improved" on the Subject's Overall Self-Assessment Rating
Time Frame:
Visits 3-5
Safety Issue:
no

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

Additional Information

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