Safety and Efficacy Of Drospirenone and Ethinyl Estradiol vs Placebo in the Treatment of Truncal Acne

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Alexandra Kimball, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00722761
First received: July 24, 2008
Last updated: January 29, 2013
Last verified: January 2013
Results First Received: December 17, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Acne Vulgaris
Interventions: Drug: drospirenone and ethinyl estradiol
Drug: Placebo tablet

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Females, age 18 to 45 years, who achieved spontaneous menarche and had a diagnosis of truncal acne of 10 to 50 inflammatory lesions on the back and chest combined with not more than 5 nodules

Reporting Groups
  Description
Drosperinone and Ethinyl Estradiol Drospirenone (3mg) and Ethinyl estradiol (0.02mg) (YAZ)tablet once a day
Placebo Tablet Placebo tablet once a day

Participant Flow:   Overall Study
    Drosperinone and Ethinyl Estradiol     Placebo Tablet  
STARTED     16     14  
COMPLETED AT LEAST 1 FOLLOW-UP VISIT     15     10  
COMPLETED     10     8  
NOT COMPLETED     6     6  
Lost to Follow-up                 1                 4  
Withdrawal by Subject                 5                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Drosperinone and Ethinyl Estradiol Drospirenone (3mg) and Ethinyl estradiol (0.02mg) (YAZ)tablet once a day
Placebo Tablet Placebo tablet once a day
Total Total of all reporting groups

Baseline Measures
    Drosperinone and Ethinyl Estradiol     Placebo Tablet     Total  
Number of Participants  
[units: participants]
  16     14     30  
Age  
[units: years]
Mean ± Standard Deviation
  23  ± 5.1     24  ± 3.7     24  ± 4.5  
Gender, Customized  
[units: participants]
     
Female     16     14     30  
Race/Ethnicity, Customized  
[units: participants]
     
Hispanic or Latino     1     0     1  
Asian     2     2     4  
African American     2     1     3  
Caucasian     11     11     22  
BMI  
[units: kg/m2]
Mean ± Standard Deviation
  23.2  ± 2.2     23.6  ± 2.6     23.4  ± 2.9  



  Outcome Measures
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1.  Primary:   Percent Change in Truncal Lesion Counts   [ Time Frame: 0-24 weeks ]

2.  Secondary:   Percentage of Subjects Rated Clear or Almost Clear on the IGA and SGA at Week 24/ Early Termination   [ Time Frame: 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination leading to small number of subjects analyzed


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Alexa B. Kimball
Organization: MGH Curtis
phone: 617-726-5066
e-mail: harvardskinstudies@partners.org


No publications provided


Responsible Party: Alexandra Kimball, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00722761     History of Changes
Other Study ID Numbers: 2008-P-000754
Study First Received: July 24, 2008
Results First Received: December 17, 2012
Last Updated: January 29, 2013
Health Authority: United States: Institutional Review Board