Evaluate Safety &Amp; Efficacy of an Oral Contraceptive (OC) Preparation Versus Placebo for 6 Treatment Cycles in Women With Moderate Acne

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00656981
First received: April 9, 2008
Last updated: October 10, 2013
Last verified: October 2013
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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
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)

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Encino, California, United States, 91436
San Diego, California, United States, 92103
San Diego, California, United States, 92123
Westlake Village, California, United States, 91361
United States, Colorado
Castle Rock, Colorado, United States, 80108
Denver, Colorado, United States, 80246
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
Medford, Oregon, United States, 97504
Portland, Oregon, United States, 97223-6683
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:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00656981     History of Changes
Other Study ID Numbers: 91231, 306996
Study First Received: April 9, 2008
Last Updated: October 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Moderate Acne Vulgaris
Acne

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Contraceptive Agents
Contraceptives, Oral
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on August 28, 2014