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

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ClinicalTrials.gov Identifier: NCT00722761
Recruitment Status : Completed
First Posted : July 28, 2008
Results First Posted : March 5, 2013
Last Update Posted : March 5, 2013
Sponsor:
Collaborator:
Bayer
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
Enrollment 30
Recruitment Details  
Pre-assignment Details 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
Arm/Group Title Drosperinone and Ethinyl Estradiol Placebo Tablet
Hide Arm/Group Description Drospirenone (3mg) and Ethinyl estradiol (0.02mg) (YAZ)tablet once a day Placebo tablet once a day
Period Title: Overall Study
Started 16 14
COMPLETED AT LEAST 1 FOLLOW-UP VISIT 15 10
Completed 10 8
Not Completed 6 6
Reason Not Completed
Lost to Follow-up             1             4
Withdrawal by Subject             5             2
Arm/Group Title Drosperinone and Ethinyl Estradiol Placebo Tablet Total
Hide Arm/Group Description Drospirenone (3mg) and Ethinyl estradiol (0.02mg) (YAZ)tablet once a day Placebo tablet once a day Total of all reporting groups
Overall Number of Baseline Participants 16 14 30
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 14 participants 30 participants
23  (5.1) 24  (3.7) 24  (4.5)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Female Number Analyzed 16 participants 14 participants 30 participants
16 14 30
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 16 participants 14 participants 30 participants
Hispanic or Latino 1 0 1
Asian 2 2 4
African American 2 1 3
Caucasian 11 11 22
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 16 participants 14 participants 30 participants
23.2  (2.2) 23.6  (2.6) 23.4  (2.9)
1.Primary Outcome
Title Percent Change in Truncal Lesion Counts
Hide Description Acne lesion count (noninflammatory, inflammatory and total lesions) difference between week 0 (baseline) and week 24 is divided by the acne lesion count at week 0 and multiplied by 100. A positive change indicates a decrease in truncal acne lesions.
Time Frame 0-24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis. Only participants with at least one follow up were included in the analysis. Last observation carried forward was used to fill up missing data.
Arm/Group Title Drosperinone and Ethinyl Estradiol Placebo Tablet
Hide Arm/Group Description:
Drospirenone (3mg) and Ethinyl estradiol (0.02mg) (YAZ)tablet once a day
Placebo tablet once a day
Overall Number of Participants Analyzed 15 10
Mean (Standard Deviation)
Unit of Measure: percentage change of lesions
Noninflammatory lesions 52.1  (43.3) -9.2  (77.6)
Inflammatory lesions 53.2  (40.9) 18.2  (40.1)
Total acne lesions 51.8  (31.9) 17  (47.1)
2.Secondary Outcome
Title Percentage of Subjects Rated Clear or Almost Clear on the IGA and SGA at Week 24/ Early Termination
Hide Description Percentage of subjects rated Clear (score 0) or Almost Clear (score 1) on the Investigator's Global Assessment (IGA) of truncal acne at Week 24 as well as Subject's Assessment of Acne at Week 24/Early Termination were taken. It was computed by: number of successes (those scored 0 or 1)divided by the number of participants multiplied by 100.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis. Participants with at least one follow up visit were included in the analysis. Last observation carried forward was used to fill up missing values/
Arm/Group Title Drosperinone and Ethinyl Estradiol Placebo Tablet
Hide Arm/Group Description:
Drospirenone (3mg) and Ethinyl estradiol (0.02mg) (YAZ)tablet once a day
Placebo tablet once a day
Overall Number of Participants Analyzed 15 10
Measure Type: Number
Unit of Measure: percentage of participants
Investigator Global Assessment IGA 53.3 20
Subject Assessment SGA 60 80
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Drosperinone and Ethinyl Estradiol Placebo Tablet
Hide Arm/Group Description Drospirenone (3mg) and Ethinyl estradiol (0.02mg) (YAZ)tablet once a day Placebo tablet once a day
All-Cause Mortality
Drosperinone and Ethinyl Estradiol Placebo Tablet
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Drosperinone and Ethinyl Estradiol Placebo Tablet
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/16 (0.00%)      0/14 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Drosperinone and Ethinyl Estradiol Placebo Tablet
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/16 (12.50%)      0/14 (0.00%)    
Nervous system disorders     
Headache   2/16 (12.50%)  2 0/14 (0.00%)  0
Loss of appetite   1/16 (6.25%)  1 0/14 (0.00%)  0
moodiness   1/16 (6.25%)  1 0/14 (0.00%)  0
Reproductive system and breast disorders     
break through bleeding   1/16 (6.25%)  1 0/14 (0.00%)  0
Indicates events were collected by systematic assessment
Early termination leading to small number of subjects analyzed
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
ClinicalTrials.gov 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