Evaluate Safety & Efficacy of an Oral Contraceptive (OC) Preparation Versus Placebo for 6 Treatment Cycles in Women With Moderate Acne - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00656981

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

Condition	Intervention	Phase
Acne Vulgaris	Drug: YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300) Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Acne

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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

Enrollment:	500
Study Start Date:	January 2003
Study Completion Date:	June 2004

Arms	Assigned Interventions
Arm 1: Experimental	Drug: YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300) 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).
Arm 2: Placebo Comparator	Drug: Placebo 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)

Arms

Assigned Interventions

Arm 1: Experimental

Drug: YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)

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).

Arm 2: Placebo Comparator

Drug: Placebo

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

Ages Eligible for Study:	14 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00656981

Locations

United States, Alabama

Mobile, Alabama, United States, 36608
United States, Arizona

Kingman, Arizona, United States, 86401
United States, California

Westlake Village, California, United States, 91361

Encino, California, United States, 91436

San Diego, California, United States, 92123

San Diego, California, United States, 92103
United States, Colorado

Denver, Colorado, United States, 80246

Castle Rock, Colorado, United States, 80108
United States, Florida

Palm Springs, Florida, United States, 33461

St. Petersburg, Florida, United States, 33702

Venice, Florida, United States, 34285
United States, Idaho

Boise, Idaho, United States, 83704
United States, Kansas

Shawnee, Kansas, United States, 66203
United States, Kentucky

Louisville, Kentucky, United States, 40217
United States, Minnesota

Fridley, Minnesota, United States, 55432
United States, New York

East Steauket, New York, United States, 11733

New York, New York, United States, 10022
United States, Oregon

Portland, Oregon, United States, 97223-6683

Medford, Oregon, United States, 97504
United States, Texas

Byran, Texas, United States, 77801
United States, Virginia

Arlington, Virginia, United States, 22203
United States, Washington

Seattle, Washington, United States, 98105

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

Click here to find results for studies related to marketed products This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bayer HealthCare Pharmaceuticals Inc. ( Therapeutic Area Head )
Study ID Numbers:	91231, 306996
Study First Received:	April 9, 2008
Last Updated:	July 8, 2009
ClinicalTrials.gov Identifier:	NCT00656981 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Moderate Acne Vulgaris
Acne

Additional relevant MeSH terms:

Facial Dermatoses
Skin Diseases
Contraceptive Agents
Acneiform Eruptions
Therapeutic Uses
Physiological Effects of Drugs

Contraceptives, Oral
Contraceptive Agents, Female
Reproductive Control Agents
Sebaceous Gland Diseases
Pharmacologic Actions
Acne Vulgaris

ClinicalTrials.gov processed this record on February 08, 2010