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

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. Identifier: NCT00722761
Recruitment Status : Completed
First Posted : July 28, 2008
Results First Posted : March 5, 2013
Last Update Posted : March 5, 2013
Information provided by (Responsible Party):
Alexandra Kimball, Massachusetts General Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Acne Vulgaris
Interventions: Drug: drospirenone and ethinyl estradiol
Drug: Placebo tablet

  Participant Flow

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
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   10   8 
Lost to Follow-up                1                4 
Withdrawal by Subject                5                2 

  Baseline Characteristics

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
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 
Overall Participants Analyzed 
[Units: Participants]
 16   14   30 
[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 
[Units: Kg/m2]
Mean (Standard Deviation)
 23.2  (2.2)   23.6  (2.6)   23.4  (2.9) 

  Outcome Measures

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

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

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

Responsible Party: Alexandra Kimball, Massachusetts General Hospital Identifier: NCT00722761     History of Changes
Other Study ID Numbers: 2008-P-000754
First Submitted: July 24, 2008
First Posted: July 28, 2008
Results First Submitted: December 17, 2012
Results First Posted: March 5, 2013
Last Update Posted: March 5, 2013