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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00651469
First Posted: April 2, 2008
Last Update Posted: December 30, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  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

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

Study Type: Interventional
Study Design: 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.

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 ]

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

Enrollment: 534
Study Start Date: January 2003
Study Completion Date: July 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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00651469


  Show 27 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00651469     History of Changes
Other Study ID Numbers: 91209
306820 ( Other Identifier: Company Internal )
First Submitted: March 31, 2008
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