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

December 29, 2014 updated by: Bayer

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

534

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
      • Huntsville, Alabama, United States, 35801
    • Arizona
      • Mesa, Arizona, United States, 85201
    • California
      • Los Angeles, California, United States, 90010
      • San Diego, California, United States, 92108
    • District of Columbia
      • Washington, District of Columbia, United States, 20010-2975
    • Florida
      • Miami, Florida, United States, 33175
      • St. Petersburg, Florida, United States, 33702
      • Tampa, Florida, United States, 33607
    • Idaho
      • Boise, Idaho, United States, 83704
    • Illinois
      • Chicago, Illinois, United States, 60631
    • Indiana
      • Indianapolis, Indiana, United States, 46250
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
    • Massachusetts
      • Wellesley, Massachusetts, United States, 02481
    • Missouri
      • Kansas City, Missouri, United States, 64114
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
      • Winston-Salem, North Carolina, United States, 27157
    • Ohio
      • Cincinnati, Ohio, United States, 45230
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033-0850
      • Philadelphia, Pennsylvania, United States, 19114
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
    • Texas
      • Austin, Texas, United States, 78759
      • Dallas, Texas, United States, 75230
      • Houston, Texas, United States, 77024
      • San Antonio, Texas, United States, 78229
    • Washington
      • Tacoma, Washington, United States, 98405

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
From baseline to Cycle 6

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Study Completion (Actual)

July 1, 2004

Study Registration Dates

First Submitted

March 31, 2008

First Submitted That Met QC Criteria

April 1, 2008

First Posted (Estimate)

April 2, 2008

Study Record Updates

Last Update Posted (Estimate)

December 30, 2014

Last Update Submitted That Met QC Criteria

December 29, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91209
  • 306820 (Other Identifier: Company Internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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