Trial Outcomes & Findings for Safety and Efficacy Of Drospirenone and Ethinyl Estradiol vs Placebo in the Treatment of Truncal Acne (NCT NCT00722761)
NCT ID: NCT00722761
Last Updated: 2013-03-05
Results Overview
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.
COMPLETED
PHASE3
30 participants
0-24 weeks
2013-03-05
Participant Flow
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
Participant milestones
| Measure |
Drosperinone and Ethinyl Estradiol
Drospirenone (3mg) and Ethinyl estradiol (0.02mg) (YAZ)tablet once a day
|
Placebo Tablet
Placebo tablet once a day
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
14
|
|
Overall Study
COMPLETED AT LEAST 1 FOLLOW-UP VISIT
|
15
|
10
|
|
Overall Study
COMPLETED
|
10
|
8
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
Drosperinone and Ethinyl Estradiol
Drospirenone (3mg) and Ethinyl estradiol (0.02mg) (YAZ)tablet once a day
|
Placebo Tablet
Placebo tablet once a day
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
|
Overall Study
Withdrawal by Subject
|
5
|
2
|
Baseline Characteristics
Safety and Efficacy Of Drospirenone and Ethinyl Estradiol vs Placebo in the Treatment of Truncal Acne
Baseline characteristics by cohort
| Measure |
Drosperinone and Ethinyl Estradiol
n=16 Participants
Drospirenone (3mg) and Ethinyl estradiol (0.02mg) (YAZ)tablet once a day
|
Placebo Tablet
n=14 Participants
Placebo tablet once a day
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
23 years
STANDARD_DEVIATION 5.1 • n=99 Participants
|
24 years
STANDARD_DEVIATION 3.7 • n=107 Participants
|
24 years
STANDARD_DEVIATION 4.5 • n=206 Participants
|
|
Sex/Gender, Customized
Female
|
16 participants
n=99 Participants
|
14 participants
n=107 Participants
|
30 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
11 participants
n=99 Participants
|
11 participants
n=107 Participants
|
22 participants
n=206 Participants
|
|
BMI
|
23.2 kg/m2
STANDARD_DEVIATION 2.2 • n=99 Participants
|
23.6 kg/m2
STANDARD_DEVIATION 2.6 • n=107 Participants
|
23.4 kg/m2
STANDARD_DEVIATION 2.9 • n=206 Participants
|
PRIMARY outcome
Timeframe: 0-24 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Drosperinone and Ethinyl Estradiol
n=15 Participants
Drospirenone (3mg) and Ethinyl estradiol (0.02mg) (YAZ)tablet once a day
|
Placebo Tablet
n=10 Participants
Placebo tablet once a day
|
|---|---|---|
|
Percent Change in Truncal Lesion Counts
Noninflammatory lesions
|
52.1 percentage change of lesions
Standard Deviation 43.3
|
-9.2 percentage change of lesions
Standard Deviation 77.6
|
|
Percent Change in Truncal Lesion Counts
Inflammatory lesions
|
53.2 percentage change of lesions
Standard Deviation 40.9
|
18.2 percentage change of lesions
Standard Deviation 40.1
|
|
Percent Change in Truncal Lesion Counts
Total acne lesions
|
51.8 percentage change of lesions
Standard Deviation 31.9
|
17 percentage change of lesions
Standard Deviation 47.1
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: 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/
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.
Outcome measures
| Measure |
Drosperinone and Ethinyl Estradiol
n=15 Participants
Drospirenone (3mg) and Ethinyl estradiol (0.02mg) (YAZ)tablet once a day
|
Placebo Tablet
n=10 Participants
Placebo tablet once a day
|
|---|---|---|
|
Percentage of Subjects Rated Clear or Almost Clear on the IGA and SGA at Week 24/ Early Termination
Investigator Global Assessment IGA
|
53.3 percentage of participants
|
20 percentage of participants
|
|
Percentage of Subjects Rated Clear or Almost Clear on the IGA and SGA at Week 24/ Early Termination
Subject Assessment SGA
|
60 percentage of participants
|
80 percentage of participants
|
Adverse Events
Drosperinone and Ethinyl Estradiol
Placebo Tablet
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Drosperinone and Ethinyl Estradiol
n=16 participants at risk
Drospirenone (3mg) and Ethinyl estradiol (0.02mg) (YAZ)tablet once a day
|
Placebo Tablet
n=14 participants at risk
Placebo tablet once a day
|
|---|---|---|
|
Nervous system disorders
Headache
|
12.5%
2/16 • Number of events 2
|
0.00%
0/14
|
|
Nervous system disorders
Loss of appetite
|
6.2%
1/16 • Number of events 1
|
0.00%
0/14
|
|
Nervous system disorders
moodiness
|
6.2%
1/16 • Number of events 1
|
0.00%
0/14
|
|
Reproductive system and breast disorders
break through bleeding
|
6.2%
1/16 • Number of events 1
|
0.00%
0/14
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place