check_circleStudy 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
  • - 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).
  • - 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

StatusInstitutionLocation
Completed
Visions Clinical ResearchPalm 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 CenterPortland, 97223-6683, United States
Completed
Westlake Medical ResearchWestlake 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 WomenNew York, 10022, United States
Completed
Clinical Trial Center of ColoradoCastle Rock, 80108, United States
Completed
Women's Clinical Research CenterSeattle, 98105, United States
Completed
Genesis Center for Clinical ResearchSan Diego, 92103, United States
Completed
OB/GYN Health CenterMedford, 97504, United States
Completed
Arizona Desert DermatologyKingman, 86401, United States
Completed
Comprehensive NeuroScience, Inc.St. Petersburg, 33702, United States
Completed
Advanced Clinical ResearchBoise, 83704, United States
Completed
J & S Studies, Inc.Byran, 77801, United States
Completed
Minnesota Clinical Study CenterFridley, 55432, United States
Completed
Millennium Clinical Research CenterArlington, 22203, United States
Completed
Coastal Clinical Research, IncMobile, 36608, United States
Completed
Dr. Robert Semo, MDVenice, 34285, United States
Completed
Physician's Skin CareLouisville, 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.
    date_rangeTime Frame:
    From baseline to Cycle 6.
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Change from baseline in count of papules
    date_rangeTime Frame:
    Visits 3-5
    enhanced_encryption
    Safety Issue:
    no
  • Change from baseline in count of pustules
    date_rangeTime Frame:
    Visits 3-5
    enhanced_encryption
    Safety Issue:
    no
  • Change from baseline in count of nodules
    date_rangeTime Frame:
    Visits 3-5
    enhanced_encryption
    Safety Issue:
    no
  • Change from baseline in count of open comedones
    date_rangeTime Frame:
    Visits 3-5
    enhanced_encryption
    Safety Issue:
    no
  • Change from baseline in count of closed comedones
    date_rangeTime Frame:
    Visits 3-5
    enhanced_encryption
    Safety Issue:
    no
  • Percentage of subjects classified as "improved" according to the Investigator's Overall Improvement Rating
    date_rangeTime Frame:
    Visits 3-5
    enhanced_encryption
    Safety Issue:
    no
  • Percentage of subjects classifying themselves as "improved" on the Subject's Overall Self-Assessment Rating
    date_rangeTime Frame:
    Visits 3-5
    enhanced_encryption
    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
2

Additional Information

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