check_circleStudy Completed

Acne Vulgaris

Bayer Identifier:

91209

ClinicalTrials.gov Identifier:

NCT00651469

EudraCT Number:

Not Available

EU CT Number:

Not Available
Evaluate Safety and Efficacy of an OC Preparation vs 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 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

Trial summary

Enrollment Goal
534
Trial Dates
January 2003 - July 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
Radiant Research - BirminghamBirmingham, 35209, United States
Completed
nTouch ResearchHouston, 77024, United States
Completed
Radiant Research - BirminghamBirmingham, 35209, United States
Completed
Radiant Research - BirminghamBirmingham, 35209, United States
Completed
Medical Center for Clinical ResearchSan Diego, 92108, United States
Completed
Piedmont Medical Research Associates Inc.Winston-Salem, 27103, United States
Completed
Washington Hospital CenterWashington, 20010-2975, United States
Completed
Radiant Research - BirminghamBirmingham, 35209, United States
Completed
Desert Clinical ResearchMesa, 85201, United States
Completed
Penn State Milton S. Hershey Medical CenterHershey, 17033-0850, United States
Completed
Academic Dermatology AssociatesAlbuquerque, 87106, United States
Completed
FXM ResearchMiami, 33175, United States
Terminated
Boston Clinical Research CenterWellesley, 02481, United States
Completed
Impact Clinical TrialsLos Angeles, 90010, United States
Completed
Medical Affiliated Research CenterHuntsville, 35801, United States
Completed
Texas Dermatology Research InstituteDallas, 75230, United States
Completed
Radiant Research - BirminghamBirmingham, 35209, United States
Completed
Dermatology Clinical Research CenterSan Antonio, 78229, United States
Completed
Wake Forest University School of MedicineWinston-Salem, 27157, United States
Completed
Omega Medical ResearchWarwick, 02886, United States
Completed
DermResearch, Inc.Austin, 78759, United States
Completed
Dermatology Research Associates, Inc.Cincinnati, 45230, United States
Completed
Compliant Clinical Research Inc.Kansas City, 64114, United States
Completed
Comprehensive NeuroScience, Inc.St. Petersburg, 33702, United States
Completed
Advanced Clinical ResearchBoise, 83704, United States
Terminated
nTouch ResearchHouston, 77024, United States
Completed
Philadelphia Clinical ResearchPhiladelphia, 19114, United States
Completed
Insignia Care for Women, P.A.Tampa, 33607, United States
Completed
Women's Center for Clinical ResearchNew Orleans, 70115, United States
Completed
Physicians Research GroupIndianapolis, 46250, United States
Completed
Dr. John Lenihan, MDTacoma, 98405, United States
Terminated
Peryam & Kroll Healthcare ResearchChicago, 60631, 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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