Trial Outcomes & Findings for P2 Multi-center Study of SB204 Gel in the Treatment of Acne Vulgaris (NCT NCT02242760)
NCT ID: NCT02242760
Last Updated: 2023-05-31
Results Overview
Change in inflammatory lesion count from Baseline to Week 12
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
213 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2023-05-31
Participant Flow
Participant milestones
| Measure |
Vehicle Gel QD
Vehicle Gel: Applied topically once daily
|
Vehicle Gel BID
Vehicle Gel: Applied topically twice daily
|
SB204 2% BID
SB204 2%: Applied topically twice daily
|
SB204 4% QD
SB204 4%: Applied topically once daily
|
SB204 4% BID
SB204 4%: Applied topically twice daily
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
27
|
29
|
53
|
52
|
52
|
|
Overall Study
Number of Subjects Excluded From ITT Population
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
COMPLETED
|
24
|
20
|
51
|
48
|
48
|
|
Overall Study
NOT COMPLETED
|
3
|
9
|
2
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
Baseline characteristics by cohort
| Measure |
Vehicle Gel QD
n=27 Participants
Vehicle Gel: Applied topically once daily
|
Vehicle Gel BID
n=29 Participants
Vehicle Gel: Applied topically twice daily
|
SB204 2% BID
n=53 Participants
SB204 2%: Applied topically twice daily
|
SB204 4% QD
n=52 Participants
SB204 4%: Applied topically once daily
|
SB204 4% BID
n=51 Participants
SB204 4%: Applied topically twice daily
|
Total
n=212 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
SB204
|
—
|
—
|
20.1 years
STANDARD_DEVIATION 6.81 • n=53 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
18.8 years
STANDARD_DEVIATION 5.00 • n=52 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
20.1 years
STANDARD_DEVIATION 6.94 • n=51 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
19.6 years
STANDARD_DEVIATION 6.30 • n=156 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
|
Age, Continuous
Vehicle
|
16.7 years
STANDARD_DEVIATION 4.84 • n=27 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
19.7 years
STANDARD_DEVIATION 6.33 • n=29 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
—
|
—
|
—
|
18.2 years
STANDARD_DEVIATION 5.81 • n=56 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
|
Sex: Female, Male
SB204 · Female
|
—
|
—
|
26 Participants
n=53 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
29 Participants
n=52 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
29 Participants
n=51 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
84 Participants
n=156 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
|
Sex: Female, Male
SB204 · Male
|
—
|
—
|
27 Participants
n=53 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
23 Participants
n=52 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
22 Participants
n=51 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
72 Participants
n=156 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
|
Sex: Female, Male
Vehicle · Female
|
11 Participants
n=27 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
16 Participants
n=29 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
—
|
—
|
—
|
27 Participants
n=56 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
|
Sex: Female, Male
Vehicle · Male
|
16 Participants
n=27 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
13 Participants
n=29 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
—
|
—
|
—
|
29 Participants
n=56 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
|
Ethnicity (NIH/OMB)
SB204 · Hispanic or Latino
|
—
|
—
|
13 Participants
n=53 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
10 Participants
n=52 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
9 Participants
n=51 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
32 Participants
n=156 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
|
Ethnicity (NIH/OMB)
SB204 · Not Hispanic or Latino
|
—
|
—
|
40 Participants
n=53 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
42 Participants
n=52 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
42 Participants
n=51 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
124 Participants
n=156 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
|
Ethnicity (NIH/OMB)
SB204 · Unknown or Not Reported
|
—
|
—
|
0 Participants
n=53 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
0 Participants
n=52 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
0 Participants
n=51 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
0 Participants
n=156 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
|
Ethnicity (NIH/OMB)
Vehicle · Hispanic or Latino
|
4 Participants
n=27 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
4 Participants
n=29 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
—
|
—
|
—
|
8 Participants
n=56 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
|
Ethnicity (NIH/OMB)
Vehicle · Not Hispanic or Latino
|
23 Participants
n=27 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
25 Participants
n=29 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
—
|
—
|
—
|
48 Participants
n=56 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
|
Ethnicity (NIH/OMB)
Vehicle · Unknown or Not Reported
|
0 Participants
n=27 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
0 Participants
n=29 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
—
|
—
|
—
|
0 Participants
n=56 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
|
Race (NIH/OMB)
SB204 · American Indian or Alaska Native
|
—
|
—
|
0 Participants
n=53 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
0 Participants
n=52 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
0 Participants
n=51 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
0 Participants
n=156 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
|
Race (NIH/OMB)
SB204 · Asian
|
—
|
—
|
2 Participants
n=53 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
3 Participants
n=52 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
3 Participants
n=51 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
8 Participants
n=156 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
|
Race (NIH/OMB)
SB204 · Native Hawaiian or Other Pacific Islander
|
—
|
—
|
1 Participants
n=53 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
2 Participants
n=52 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
0 Participants
n=51 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
3 Participants
n=156 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
|
Race (NIH/OMB)
SB204 · Black or African American
|
—
|
—
|
9 Participants
n=53 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
6 Participants
n=52 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
10 Participants
n=51 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
25 Participants
n=156 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
|
Race (NIH/OMB)
SB204 · White
|
—
|
—
|
41 Participants
n=53 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
36 Participants
n=52 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
36 Participants
n=51 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
113 Participants
n=156 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
|
Race (NIH/OMB)
SB204 · More than one race
|
—
|
—
|
0 Participants
n=53 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
5 Participants
n=52 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
2 Participants
n=51 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
7 Participants
n=156 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
|
Race (NIH/OMB)
SB204 · Unknown or Not Reported
|
—
|
—
|
0 Participants
n=53 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
0 Participants
n=52 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
0 Participants
n=51 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
0 Participants
n=156 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
|
Race (NIH/OMB)
Vehicle · American Indian or Alaska Native
|
0 Participants
n=27 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
0 Participants
n=29 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
—
|
—
|
—
|
0 Participants
n=56 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
|
Race (NIH/OMB)
Vehicle · Asian
|
0 Participants
n=27 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
0 Participants
n=29 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
—
|
—
|
—
|
0 Participants
n=56 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
|
Race (NIH/OMB)
Vehicle · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=27 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
0 Participants
n=29 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
—
|
—
|
—
|
0 Participants
n=56 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
|
Race (NIH/OMB)
Vehicle · Black or African American
|
4 Participants
n=27 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
5 Participants
n=29 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
—
|
—
|
—
|
9 Participants
n=56 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
|
Race (NIH/OMB)
Vehicle · White
|
23 Participants
n=27 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
21 Participants
n=29 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
—
|
—
|
—
|
44 Participants
n=56 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
|
Race (NIH/OMB)
Vehicle · More than one race
|
0 Participants
n=27 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
3 Participants
n=29 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
—
|
—
|
—
|
3 Participants
n=56 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
|
Race (NIH/OMB)
Vehicle · Unknown or Not Reported
|
0 Participants
n=27 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
0 Participants
n=29 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
—
|
—
|
—
|
0 Participants
n=56 Participants • The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
|
Region of Enrollment
United States · SB204
|
0 Participants
n=27 Participants • The SAP specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. The SB204 cohorts are presented in Row 1--columns 3, 4, and 5 represent the individual SB204 cohorts, while column 6 represents the combined SB204 cohort. The vehicle gel cohorts are presented in Row 2. The individual vehicle cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
0 Participants
n=29 Participants • The SAP specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. The SB204 cohorts are presented in Row 1--columns 3, 4, and 5 represent the individual SB204 cohorts, while column 6 represents the combined SB204 cohort. The vehicle gel cohorts are presented in Row 2. The individual vehicle cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
53 Participants
n=53 Participants • The SAP specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. The SB204 cohorts are presented in Row 1--columns 3, 4, and 5 represent the individual SB204 cohorts, while column 6 represents the combined SB204 cohort. The vehicle gel cohorts are presented in Row 2. The individual vehicle cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
52 Participants
n=52 Participants • The SAP specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. The SB204 cohorts are presented in Row 1--columns 3, 4, and 5 represent the individual SB204 cohorts, while column 6 represents the combined SB204 cohort. The vehicle gel cohorts are presented in Row 2. The individual vehicle cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
51 Participants
n=51 Participants • The SAP specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. The SB204 cohorts are presented in Row 1--columns 3, 4, and 5 represent the individual SB204 cohorts, while column 6 represents the combined SB204 cohort. The vehicle gel cohorts are presented in Row 2. The individual vehicle cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
156 Participants
n=212 Participants • The SAP specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. The SB204 cohorts are presented in Row 1--columns 3, 4, and 5 represent the individual SB204 cohorts, while column 6 represents the combined SB204 cohort. The vehicle gel cohorts are presented in Row 2. The individual vehicle cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
|
Region of Enrollment
United States · Vehicle
|
27 Participants
n=27 Participants • The SAP specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. The SB204 cohorts are presented in Row 1--columns 3, 4, and 5 represent the individual SB204 cohorts, while column 6 represents the combined SB204 cohort. The vehicle gel cohorts are presented in Row 2. The individual vehicle cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
29 Participants
n=29 Participants • The SAP specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. The SB204 cohorts are presented in Row 1--columns 3, 4, and 5 represent the individual SB204 cohorts, while column 6 represents the combined SB204 cohort. The vehicle gel cohorts are presented in Row 2. The individual vehicle cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
0 Participants
n=53 Participants • The SAP specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. The SB204 cohorts are presented in Row 1--columns 3, 4, and 5 represent the individual SB204 cohorts, while column 6 represents the combined SB204 cohort. The vehicle gel cohorts are presented in Row 2. The individual vehicle cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
0 Participants
n=52 Participants • The SAP specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. The SB204 cohorts are presented in Row 1--columns 3, 4, and 5 represent the individual SB204 cohorts, while column 6 represents the combined SB204 cohort. The vehicle gel cohorts are presented in Row 2. The individual vehicle cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
0 Participants
n=51 Participants • The SAP specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. The SB204 cohorts are presented in Row 1--columns 3, 4, and 5 represent the individual SB204 cohorts, while column 6 represents the combined SB204 cohort. The vehicle gel cohorts are presented in Row 2. The individual vehicle cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
56 Participants
n=212 Participants • The SAP specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. The SB204 cohorts are presented in Row 1--columns 3, 4, and 5 represent the individual SB204 cohorts, while column 6 represents the combined SB204 cohort. The vehicle gel cohorts are presented in Row 2. The individual vehicle cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent to treat population (ITT)
Change in inflammatory lesion count from Baseline to Week 12
Outcome measures
| Measure |
Vehicle Gel QD
n=27 Participants
Vehicle Gel: Applied topically once daily
|
Vehicle Gel BID
n=29 Participants
Vehicle Gel: Applied topically twice daily
|
SB204 2% BID
n=53 Participants
SB204 2%: Applied topically twice daily
|
SB204 4% QD
n=52 Participants
SB204 4%: Applied topically once daily
|
SB204 4% BID
n=51 Participants
SB204 4%: Applied topically twice daily
|
|---|---|---|---|---|---|
|
Absolute Change in Inflammatory Lesion Counts
|
-7.7 inflammatory acne lesions
Standard Deviation 10.51
|
-4.1 inflammatory acne lesions
Standard Deviation 12.77
|
-11.2 inflammatory acne lesions
Standard Deviation 9.48
|
-11.3 inflammatory acne lesions
Standard Deviation 9.66
|
-10.4 inflammatory acne lesions
Standard Deviation 9.65
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent to treat (ITT) population
Absolute Change in non-inflammatory lesion count from Baseline to Week 12
Outcome measures
| Measure |
Vehicle Gel QD
n=27 Participants
Vehicle Gel: Applied topically once daily
|
Vehicle Gel BID
n=29 Participants
Vehicle Gel: Applied topically twice daily
|
SB204 2% BID
n=53 Participants
SB204 2%: Applied topically twice daily
|
SB204 4% QD
n=52 Participants
SB204 4%: Applied topically once daily
|
SB204 4% BID
n=51 Participants
SB204 4%: Applied topically twice daily
|
|---|---|---|---|---|---|
|
Absolute Change in Non-inflammatory Lesion Counts
|
-8.4 non-inflammatory acne lesions
Standard Deviation 16.16
|
-6.9 non-inflammatory acne lesions
Standard Deviation 18.16
|
-12.3 non-inflammatory acne lesions
Standard Deviation 14.91
|
-14.1 non-inflammatory acne lesions
Standard Deviation 15.13
|
-11.1 non-inflammatory acne lesions
Standard Deviation 17.65
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent to treat (ITT) population. Count of participants = number of participants achieving success on the Investigator's Global Assessment at Week 12: a score of clear (0) or almost clear (1) and at least 2 grades less than Baseline.
Proportion of subjects at end of treatment achieving IGA of 'clear' or 'almost clear' and a change of at least 2 in the IGA from baseline. The IGA was a static assessment. The assessment was made with the evaluator approximately 3 feet away from the subject; the IGA assessment was to be done prior to the lesion counts. A lower grade is considered to be a better outcome. Grade 0 = clear (clear skin with no inflammatory or non-inflammatory lesions) Grade 1 = almost clear (few non-inflammatory lesions with no more than rare papules (papules may be resolving and hyperpigmented, though not pink-red) Grade 2 = mild (some non-inflammatory lesions with no more than a few inflammatory lesions) Grade 3 = moderate (up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 nodular lesion) Grade 4= severe (up to many non-inflammatory and inflammatory lesions, including nodular lesions)
Outcome measures
| Measure |
Vehicle Gel QD
n=27 Participants
Vehicle Gel: Applied topically once daily
|
Vehicle Gel BID
n=29 Participants
Vehicle Gel: Applied topically twice daily
|
SB204 2% BID
n=53 Participants
SB204 2%: Applied topically twice daily
|
SB204 4% QD
n=52 Participants
SB204 4%: Applied topically once daily
|
SB204 4% BID
n=51 Participants
SB204 4%: Applied topically twice daily
|
|---|---|---|---|---|---|
|
Proportion of Success According to the Dichotomized Investigator Global Assessment [IGA] at End of Treatment
|
2 Participants
|
2 Participants
|
8 Participants
|
6 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Intent to treat (ITT) population
The percent change in inflammatory lesion count from Baseline to Week 12
Outcome measures
| Measure |
Vehicle Gel QD
n=27 Participants
Vehicle Gel: Applied topically once daily
|
Vehicle Gel BID
n=29 Participants
Vehicle Gel: Applied topically twice daily
|
SB204 2% BID
n=53 Participants
SB204 2%: Applied topically twice daily
|
SB204 4% QD
n=52 Participants
SB204 4%: Applied topically once daily
|
SB204 4% BID
n=51 Participants
SB204 4%: Applied topically twice daily
|
|---|---|---|---|---|---|
|
Percent Change in Inflammatory Lesion Count From Baseline to Week 12
|
-26.2 Percentage change from baseline
Standard Deviation 34.78
|
-12.5 Percentage change from baseline
Standard Deviation 48.25
|
-41.9 Percentage change from baseline
Standard Deviation 31.35
|
-41.6 Percentage change from baseline
Standard Deviation 36.6
|
-42.1 Percentage change from baseline
Standard Deviation 35.12
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Intent to treat (ITT) population
The percent change in non-inflammatory lesion count from Baseline to Week 12
Outcome measures
| Measure |
Vehicle Gel QD
n=27 Participants
Vehicle Gel: Applied topically once daily
|
Vehicle Gel BID
n=29 Participants
Vehicle Gel: Applied topically twice daily
|
SB204 2% BID
n=53 Participants
SB204 2%: Applied topically twice daily
|
SB204 4% QD
n=52 Participants
SB204 4%: Applied topically once daily
|
SB204 4% BID
n=51 Participants
SB204 4%: Applied topically twice daily
|
|---|---|---|---|---|---|
|
Percent Change in Non-inflammatory Lesion Count From Baseline to Week 12
|
-20.2 Percentage change from baseline
Standard Deviation 42.54
|
-14.3 Percentage change from baseline
Standard Deviation 54.10
|
-33.8 Percentage change from baseline
Standard Deviation 33.91
|
-36.8 Percentage change from baseline
Standard Deviation 35.54
|
-33.0 Percentage change from baseline
Standard Deviation 40.16
|
SECONDARY outcome
Timeframe: Baseline through Week 12Population: Intent to treat (ITT) population. The vehicle QD and vehicle BID arms were combined per the study Statistical Analysis Plan: "Median time to improvement will be calculated using the Kaplan-Meier method, and the Kaplan-Meier curves will be presented for each active treatment group and the combined Vehicle group."
Median time to a 35% improvement in inflammatory lesion counts (Kaplan-Meier estimate). The full range values presented below are estimates made from the Kaplan-Meier figure.
Outcome measures
| Measure |
Vehicle Gel QD
n=56 Participants
Vehicle Gel: Applied topically once daily
|
Vehicle Gel BID
n=53 Participants
Vehicle Gel: Applied topically twice daily
|
SB204 2% BID
n=52 Participants
SB204 2%: Applied topically twice daily
|
SB204 4% QD
n=51 Participants
SB204 4%: Applied topically once daily
|
SB204 4% BID
SB204 4%: Applied topically twice daily
|
|---|---|---|---|---|---|
|
Median Time to Improvement
|
11.6 Weeks
Interval 1.4 to 12.1
|
2.0 Weeks
Interval 2.0 to 14.0
|
4.1 Weeks
Interval 1.7 to 12.3
|
4.0 Weeks
Interval 1.6 to 12.0
|
—
|
Adverse Events
Vehicle Gel QD
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Vehicle Gel BID
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
SB204 2% BID
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
SB204 4% QD
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
SB204 4% BID
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vehicle Gel QD
n=26 participants at risk
Vehicle Gel: Applied topically once daily
|
Vehicle Gel BID
n=29 participants at risk
Vehicle Gel: Applied topically twice daily
|
SB204 2% BID
n=53 participants at risk
SB204 2%: Applied topically twice daily
|
SB204 4% QD
n=52 participants at risk
SB204 4%: Applied topically once daily
|
SB204 4% BID
n=51 participants at risk
SB204 4%: Applied topically twice daily
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.00%
0/26 • Adverse events (AEs) were collected from the time the subject signed the Informed Consent Form until the final study visit; an average of 12 weeks. Treatment emergent adverse events were those with an onset on or after the date of the first application of study medication. Adverse events noted prior to the first study drug administration that worsened after Baseline were also reported as AEs.
|
0.00%
0/29 • Adverse events (AEs) were collected from the time the subject signed the Informed Consent Form until the final study visit; an average of 12 weeks. Treatment emergent adverse events were those with an onset on or after the date of the first application of study medication. Adverse events noted prior to the first study drug administration that worsened after Baseline were also reported as AEs.
|
0.00%
0/53 • Adverse events (AEs) were collected from the time the subject signed the Informed Consent Form until the final study visit; an average of 12 weeks. Treatment emergent adverse events were those with an onset on or after the date of the first application of study medication. Adverse events noted prior to the first study drug administration that worsened after Baseline were also reported as AEs.
|
1.9%
1/52 • Number of events 1 • Adverse events (AEs) were collected from the time the subject signed the Informed Consent Form until the final study visit; an average of 12 weeks. Treatment emergent adverse events were those with an onset on or after the date of the first application of study medication. Adverse events noted prior to the first study drug administration that worsened after Baseline were also reported as AEs.
|
0.00%
0/51 • Adverse events (AEs) were collected from the time the subject signed the Informed Consent Form until the final study visit; an average of 12 weeks. Treatment emergent adverse events were those with an onset on or after the date of the first application of study medication. Adverse events noted prior to the first study drug administration that worsened after Baseline were also reported as AEs.
|
Other adverse events
| Measure |
Vehicle Gel QD
n=26 participants at risk
Vehicle Gel: Applied topically once daily
|
Vehicle Gel BID
n=29 participants at risk
Vehicle Gel: Applied topically twice daily
|
SB204 2% BID
n=53 participants at risk
SB204 2%: Applied topically twice daily
|
SB204 4% QD
n=52 participants at risk
SB204 4%: Applied topically once daily
|
SB204 4% BID
n=51 participants at risk
SB204 4%: Applied topically twice daily
|
|---|---|---|---|---|---|
|
General disorders
Application site dryness
|
0.00%
0/26 • Adverse events (AEs) were collected from the time the subject signed the Informed Consent Form until the final study visit; an average of 12 weeks. Treatment emergent adverse events were those with an onset on or after the date of the first application of study medication. Adverse events noted prior to the first study drug administration that worsened after Baseline were also reported as AEs.
|
0.00%
0/29 • Adverse events (AEs) were collected from the time the subject signed the Informed Consent Form until the final study visit; an average of 12 weeks. Treatment emergent adverse events were those with an onset on or after the date of the first application of study medication. Adverse events noted prior to the first study drug administration that worsened after Baseline were also reported as AEs.
|
0.00%
0/53 • Adverse events (AEs) were collected from the time the subject signed the Informed Consent Form until the final study visit; an average of 12 weeks. Treatment emergent adverse events were those with an onset on or after the date of the first application of study medication. Adverse events noted prior to the first study drug administration that worsened after Baseline were also reported as AEs.
|
5.8%
3/52 • Adverse events (AEs) were collected from the time the subject signed the Informed Consent Form until the final study visit; an average of 12 weeks. Treatment emergent adverse events were those with an onset on or after the date of the first application of study medication. Adverse events noted prior to the first study drug administration that worsened after Baseline were also reported as AEs.
|
2.0%
1/51 • Adverse events (AEs) were collected from the time the subject signed the Informed Consent Form until the final study visit; an average of 12 weeks. Treatment emergent adverse events were those with an onset on or after the date of the first application of study medication. Adverse events noted prior to the first study drug administration that worsened after Baseline were also reported as AEs.
|
|
Infections and infestations
Nasopharyngitis
|
3.8%
1/26 • Adverse events (AEs) were collected from the time the subject signed the Informed Consent Form until the final study visit; an average of 12 weeks. Treatment emergent adverse events were those with an onset on or after the date of the first application of study medication. Adverse events noted prior to the first study drug administration that worsened after Baseline were also reported as AEs.
|
6.9%
2/29 • Adverse events (AEs) were collected from the time the subject signed the Informed Consent Form until the final study visit; an average of 12 weeks. Treatment emergent adverse events were those with an onset on or after the date of the first application of study medication. Adverse events noted prior to the first study drug administration that worsened after Baseline were also reported as AEs.
|
5.7%
3/53 • Adverse events (AEs) were collected from the time the subject signed the Informed Consent Form until the final study visit; an average of 12 weeks. Treatment emergent adverse events were those with an onset on or after the date of the first application of study medication. Adverse events noted prior to the first study drug administration that worsened after Baseline were also reported as AEs.
|
3.8%
2/52 • Adverse events (AEs) were collected from the time the subject signed the Informed Consent Form until the final study visit; an average of 12 weeks. Treatment emergent adverse events were those with an onset on or after the date of the first application of study medication. Adverse events noted prior to the first study drug administration that worsened after Baseline were also reported as AEs.
|
2.0%
1/51 • Adverse events (AEs) were collected from the time the subject signed the Informed Consent Form until the final study visit; an average of 12 weeks. Treatment emergent adverse events were those with an onset on or after the date of the first application of study medication. Adverse events noted prior to the first study drug administration that worsened after Baseline were also reported as AEs.
|
|
Nervous system disorders
Headache
|
0.00%
0/26 • Adverse events (AEs) were collected from the time the subject signed the Informed Consent Form until the final study visit; an average of 12 weeks. Treatment emergent adverse events were those with an onset on or after the date of the first application of study medication. Adverse events noted prior to the first study drug administration that worsened after Baseline were also reported as AEs.
|
6.9%
2/29 • Adverse events (AEs) were collected from the time the subject signed the Informed Consent Form until the final study visit; an average of 12 weeks. Treatment emergent adverse events were those with an onset on or after the date of the first application of study medication. Adverse events noted prior to the first study drug administration that worsened after Baseline were also reported as AEs.
|
1.9%
1/53 • Adverse events (AEs) were collected from the time the subject signed the Informed Consent Form until the final study visit; an average of 12 weeks. Treatment emergent adverse events were those with an onset on or after the date of the first application of study medication. Adverse events noted prior to the first study drug administration that worsened after Baseline were also reported as AEs.
|
0.00%
0/52 • Adverse events (AEs) were collected from the time the subject signed the Informed Consent Form until the final study visit; an average of 12 weeks. Treatment emergent adverse events were those with an onset on or after the date of the first application of study medication. Adverse events noted prior to the first study drug administration that worsened after Baseline were also reported as AEs.
|
2.0%
1/51 • Adverse events (AEs) were collected from the time the subject signed the Informed Consent Form until the final study visit; an average of 12 weeks. Treatment emergent adverse events were those with an onset on or after the date of the first application of study medication. Adverse events noted prior to the first study drug administration that worsened after Baseline were also reported as AEs.
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Additional Information
Cathy White, Vice President, Drug Development Operations
Novan, Inc.
Phone: 919-485-8080
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place