Evaluate Safety and Efficacy of an OC Preparation vs Placebo for 6 Treatment Cycles in Women With Moderate Acne.

• ClinicalTrials.gov Identifier: NCT00651469
• Recruitment Status: Completed
• First Posted: April 2, 2008
• Last Update Posted: December 30, 2014
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Study Description

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.

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

Expanded Access : Bayer has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 534 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: January 2003
• Actual Study Completion Date: July 2004

Arms and Interventions

Arm	Intervention/treatment
Experimental: Arm 1	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).
Placebo Comparator: Arm 2	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)

Outcome Measures

Primary Outcome Measures :

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. [ Time Frame: From baseline to Cycle 6 ]

Secondary Outcome Measures :

1. Change from baseline in count of papules [ Time Frame: Visits 3-5 ]
2. Change from baseline in count of pustules [ Time Frame: Visits 3-5 ]
3. Change from baseline in count of nodules [ Time Frame: Visits 3-5 ]
4. Change from baseline in count of open comedones [ Time Frame: Visits 3-5 ]
5. Change from baseline in count of closed comedones [ Time Frame: Visits 3-5 ]
6. Percentage of subjects classified as "improved" according to the Investigator's Overall Improvement Rating [ Time Frame: Visits 3-5 ]
7. Percentage of subjects classifying themselves as "improved" on the Subject's Overall Self-Assessment Rating [ Time Frame: Visits 3-5 ]

Eligibility Criteria

• Ages Eligible for Study: 14 Years to 45 Years (Child, Adult)
• Sexes 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 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

Contacts and Locations

Locations

United States, Alabama

Birmingham, Alabama, United States, 35209

Huntsville, Alabama, United States, 35801

United States, Arizona

Mesa, Arizona, United States, 85201

United States, California

Los Angeles, California, United States, 90010

San Diego, California, United States, 92108

United States, District of Columbia

Washington, District of Columbia, United States, 20010-2975

United States, Florida

Miami, Florida, United States, 33175

St. Petersburg, Florida, United States, 33702

Tampa, Florida, United States, 33607

United States, Idaho

Boise, Idaho, United States, 83704

United States, Illinois

Chicago, Illinois, United States, 60631

United States, Indiana

Indianapolis, Indiana, United States, 46250

United States, Louisiana

New Orleans, Louisiana, United States, 70115

United States, Massachusetts

Wellesley, Massachusetts, United States, 02481

United States, Missouri

Kansas City, Missouri, United States, 64114

United States, New Mexico

Albuquerque, New Mexico, United States, 87106

United States, North Carolina

Winston-Salem, North Carolina, United States, 27103

Winston-Salem, North Carolina, United States, 27157

United States, Ohio

Cincinnati, Ohio, United States, 45230

United States, Pennsylvania

Hershey, Pennsylvania, United States, 17033-0850

Philadelphia, Pennsylvania, United States, 19114

United States, Rhode Island

Warwick, Rhode Island, United States, 02886

United States, Texas

Austin, Texas, United States, 78759

Dallas, Texas, United States, 75230

Houston, Texas, United States, 77024

San Antonio, Texas, United States, 78229

United States, Washington

Tacoma, Washington, United States, 98405

Sponsors and Collaborators

Bayer

Investigators

• Study Director: Bayer Study Director; Bayer

More Information

Publications of Results:

Koltun W, Maloney JM, Marr J, Kunz M. Treatment of moderate acne vulgaris using a combined oral contraceptive containing ethinylestradiol 20 μg plus drospirenone 3mg administered in a 24/4 regimen: a pooled analysis. Eur J Obstet Gynecol Reprod Biol. 2011 Apr;155(2):171-5. doi: 10.1016/j.ejogrb.2010.12.027. Epub 2011 Feb 2.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Maloney JM, Dietze P Jr, Watson D, Niknian M, Lee-Rugh S, Sampson-Landers C, Korner P. Treatment of acne using a 3-milligram drospirenone/20-microgram ethinyl estradiol oral contraceptive administered in a 24/4 regimen: a randomized controlled trial. Obstet Gynecol. 2008 Oct;112(4):773-81. doi: 10.1097/AOG.0b013e318187e1c5.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT00651469
• Other Study ID Numbers: 91209; 306820 ( Other Identifier: Company Internal )
• First Posted: April 2, 2008
• Last Update Posted: December 30, 2014
• Last Verified: December 2014

Keywords provided by Bayer:

Moderate Acne Vulgaris; Acne

Additional relevant MeSH terms:

Acne Vulgaris; Acneiform Eruptions; Skin Diseases; Sebaceous Gland Diseases