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

History of Changes

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
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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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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 ]

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2. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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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.

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

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

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