Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of SB206 in Subjects With Molluscum Contagiosum (NCT NCT03436615)
NCT ID: NCT03436615
Last Updated: 2023-05-06
Results Overview
Percent (proportion) of subjects with complete clearance of all treatable MC at Week 12. This was measured by dividing the number of subjects who showed complete clearance by the number in that treatment group (this represents our primary outcome variable).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
256 participants
Primary outcome timeframe
12 weeks
Results posted on
2023-05-06
Participant Flow
Participant milestones
| Measure |
Cohort 1: SB206 4% BID
SB206 4% topically twice daily
|
Cohort 2: SB206 8% BID
SB206 8% topically twice daily
|
Cohort 3: SB206 12% BID
SB206 12% topically twice daily
|
Cohort 4: SB206 12% QD
SB206 12% topically once daily
|
Placebo (Vehicle Gel)
Vehicle Gel topically once or twice daily
Placebo: Once or twice daily
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
47
|
48
|
47
|
48
|
66
|
|
Overall Study
COMPLETED
|
38
|
40
|
39
|
43
|
61
|
|
Overall Study
NOT COMPLETED
|
9
|
8
|
8
|
5
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
It was pre-planned to analyze the SB206 Arms/Groups and the Placebo Arm/Group separately.
Baseline characteristics by cohort
| Measure |
Cohort 1: SB206 4% BID
n=47 Participants
SB206 4% topically twice daily
|
Cohort 2: SB206 8% BID
n=48 Participants
SB206 8% topically twice daily
|
Cohort 3: SB206 12% BID
n=47 Participants
SB206 12% topically twice daily
|
Cohort 4: SB206 12% QD
n=48 Participants
SB206 12% topically once daily
|
Placebo (Vehicle Gel)
n=66 Participants
Vehicle Gel topically once or twice daily
|
Total
n=256 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
≥2 years of age
|
47 Participants
n=47 Participants
|
48 Participants
n=48 Participants
|
47 Participants
n=47 Participants
|
48 Participants
n=48 Participants
|
66 Participants
n=66 Participants
|
256 Participants
n=256 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=47 Participants
|
27 Participants
n=48 Participants
|
22 Participants
n=47 Participants
|
25 Participants
n=48 Participants
|
27 Participants
n=66 Participants
|
123 Participants
n=256 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=47 Participants
|
21 Participants
n=48 Participants
|
25 Participants
n=47 Participants
|
23 Participants
n=48 Participants
|
39 Participants
n=66 Participants
|
133 Participants
n=256 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=47 Participants
|
11 Participants
n=48 Participants
|
16 Participants
n=47 Participants
|
8 Participants
n=48 Participants
|
15 Participants
n=66 Participants
|
56 Participants
n=256 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=47 Participants
|
37 Participants
n=48 Participants
|
31 Participants
n=47 Participants
|
40 Participants
n=48 Participants
|
51 Participants
n=66 Participants
|
200 Participants
n=256 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=47 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=47 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=66 Participants
|
0 Participants
n=256 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=47 Participants
|
1 Participants
n=48 Participants
|
0 Participants
n=47 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=66 Participants
|
2 Participants
n=256 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=47 Participants
|
1 Participants
n=48 Participants
|
1 Participants
n=47 Participants
|
0 Participants
n=48 Participants
|
1 Participants
n=66 Participants
|
5 Participants
n=256 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=47 Participants
|
0 Participants
n=48 Participants
|
1 Participants
n=47 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=66 Participants
|
1 Participants
n=256 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=47 Participants
|
3 Participants
n=48 Participants
|
0 Participants
n=47 Participants
|
2 Participants
n=48 Participants
|
1 Participants
n=66 Participants
|
7 Participants
n=256 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=47 Participants
|
42 Participants
n=48 Participants
|
44 Participants
n=47 Participants
|
44 Participants
n=48 Participants
|
58 Participants
n=66 Participants
|
228 Participants
n=256 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=47 Participants
|
1 Participants
n=48 Participants
|
0 Participants
n=47 Participants
|
1 Participants
n=48 Participants
|
3 Participants
n=66 Participants
|
8 Participants
n=256 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=47 Participants
|
0 Participants
n=48 Participants
|
1 Participants
n=47 Participants
|
1 Participants
n=48 Participants
|
3 Participants
n=66 Participants
|
5 Participants
n=256 Participants
|
|
Region of Enrollment
United States
|
47 Participants
n=47 Participants
|
48 Participants
n=48 Participants
|
47 Participants
n=47 Participants
|
48 Participants
n=48 Participants
|
66 Participants
n=66 Participants
|
256 Participants
n=256 Participants
|
|
Baseline number of Molluscum lesions
SB206
|
21.7 Molluscum lesions
STANDARD_DEVIATION 17.23 • n=47 Participants • It was pre-planned to analyze the SB206 Arms/Groups and the Placebo Arm/Group separately.
|
19.0 Molluscum lesions
STANDARD_DEVIATION 14.37 • n=48 Participants • It was pre-planned to analyze the SB206 Arms/Groups and the Placebo Arm/Group separately.
|
18.8 Molluscum lesions
STANDARD_DEVIATION 16.15 • n=47 Participants • It was pre-planned to analyze the SB206 Arms/Groups and the Placebo Arm/Group separately.
|
17.6 Molluscum lesions
STANDARD_DEVIATION 16.55 • n=48 Participants • It was pre-planned to analyze the SB206 Arms/Groups and the Placebo Arm/Group separately.
|
—
|
19.3 Molluscum lesions
STANDARD_DEVIATION 16.05 • n=190 Participants • It was pre-planned to analyze the SB206 Arms/Groups and the Placebo Arm/Group separately.
|
|
Baseline number of Molluscum lesions
Placebo (vehicle gel)
|
—
|
—
|
—
|
—
|
18.3 Molluscum lesions
STANDARD_DEVIATION 14.47 • n=66 Participants • It was pre-planned to analyze the SB206 Arms/Groups and the Placebo Arm/Group separately.
|
18.3 Molluscum lesions
STANDARD_DEVIATION 14.47 • n=66 Participants • It was pre-planned to analyze the SB206 Arms/Groups and the Placebo Arm/Group separately.
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: mITT Population
Percent (proportion) of subjects with complete clearance of all treatable MC at Week 12. This was measured by dividing the number of subjects who showed complete clearance by the number in that treatment group (this represents our primary outcome variable).
Outcome measures
| Measure |
Cohort 1: SB206 4% BID
n=38 Participants
SB206 4% topically twice daily
|
Cohort 2: SB206 8% BID
n=39 Participants
SB206 8% topically twice daily
|
Cohort 3: SB206 12% BID
n=37 Participants
SB206 12% topically twice daily
|
Cohort 4: SB206 12% QD
n=43 Participants
SB206 12% topically once daily.
|
Placebo (Vehicle Gel)
n=60 Participants
Vehicle Gel topically once or twice daily
|
|---|---|---|---|---|---|
|
Proportion of Subjects Achieving Complete Clearance at Week 12
|
5 Participants
|
16 Participants
|
13 Participants
|
18 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Week 1; Week 2; Week 4; Week 8; Week 12Population: mITT population
Proportion of subjects achieving complete clearance of all treated molluscum contagiosum lesions at each visit.
Outcome measures
| Measure |
Cohort 1: SB206 4% BID
n=38 Participants
SB206 4% topically twice daily
|
Cohort 2: SB206 8% BID
n=39 Participants
SB206 8% topically twice daily
|
Cohort 3: SB206 12% BID
n=37 Participants
SB206 12% topically twice daily
|
Cohort 4: SB206 12% QD
n=43 Participants
SB206 12% topically once daily.
|
Placebo (Vehicle Gel)
n=60 Participants
Vehicle Gel topically once or twice daily
|
|---|---|---|---|---|---|
|
Proportion of Subjects Achieving Complete Clearance at Each Visit
Week 2 proportion of subjects achieving complete clearance.
|
1 participants
|
1 participants
|
1 participants
|
3 participants
|
1 participants
|
|
Proportion of Subjects Achieving Complete Clearance at Each Visit
Week 1 proportion of subjects achieving complete clearance.
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Proportion of Subjects Achieving Complete Clearance at Each Visit
Week 4 proportion of subjects achieving complete clearance.
|
1 participants
|
3 participants
|
3 participants
|
5 participants
|
2 participants
|
|
Proportion of Subjects Achieving Complete Clearance at Each Visit
Week 8 proportion of subjects achieving complete clearance.
|
3 participants
|
7 participants
|
10 participants
|
11 participants
|
6 participants
|
|
Proportion of Subjects Achieving Complete Clearance at Each Visit
Week 12 proportion of subjects achieving complete clearance.
|
5 participants
|
16 participants
|
13 participants
|
18 participants
|
12 participants
|
SECONDARY outcome
Timeframe: Week 12Population: mITT
Median time to reach first complete clearance of all molluscum contagiosum lesions (Kaplan-Meier estimate)
Outcome measures
| Measure |
Cohort 1: SB206 4% BID
n=38 Participants
SB206 4% topically twice daily
|
Cohort 2: SB206 8% BID
n=39 Participants
SB206 8% topically twice daily
|
Cohort 3: SB206 12% BID
n=37 Participants
SB206 12% topically twice daily
|
Cohort 4: SB206 12% QD
n=43 Participants
SB206 12% topically once daily.
|
Placebo (Vehicle Gel)
n=60 Participants
Vehicle Gel topically once or twice daily
|
|---|---|---|---|---|---|
|
Time to First Complete Clearance
|
NA Days
Interval 13.0 to 85.0
This was a Kaplan-Meier estimate and the median wasn't reached in the SB206 4% BID cohort due to insufficient numbers of participants achieving complete clearance.
|
100.0 Days
Interval 11.0 to 100.0
|
91.0 Days
Interval 16.0 to 91.0
|
85.0 Days
Interval 8.0 to 86.0
|
93.0 Days
Interval 17.0 to 93.0
|
SECONDARY outcome
Timeframe: Week 1, Week 2, Week 4, Week 8, Week 12Population: mITT population.
Proportion of subjects achieving 75% reduction from baseline in number of molluscum contagiosum at each visit
Outcome measures
| Measure |
Cohort 1: SB206 4% BID
n=38 Participants
SB206 4% topically twice daily
|
Cohort 2: SB206 8% BID
n=39 Participants
SB206 8% topically twice daily
|
Cohort 3: SB206 12% BID
n=37 Participants
SB206 12% topically twice daily
|
Cohort 4: SB206 12% QD
n=43 Participants
SB206 12% topically once daily.
|
Placebo (Vehicle Gel)
n=60 Participants
Vehicle Gel topically once or twice daily
|
|---|---|---|---|---|---|
|
Proportion of Subjects Achieving 75% Reduction at Each Visit
Week 1 proportion of subjects achieving complete clearance.
|
1 participants
|
1 participants
|
3 participants
|
3 participants
|
1 participants
|
|
Proportion of Subjects Achieving 75% Reduction at Each Visit
Week 2 proportion of subjects achieving complete clearance.
|
4 participants
|
1 participants
|
3 participants
|
8 participants
|
3 participants
|
|
Proportion of Subjects Achieving 75% Reduction at Each Visit
Week 4 proportion of subjects achieving complete clearance.
|
4 participants
|
6 participants
|
9 participants
|
9 participants
|
5 participants
|
|
Proportion of Subjects Achieving 75% Reduction at Each Visit
Week 8 proportion of subjects achieving complete clearance.
|
8 participants
|
14 participants
|
18 participants
|
20 participants
|
11 participants
|
|
Proportion of Subjects Achieving 75% Reduction at Each Visit
Week 12 proportion of subjects achieving complete clearance.
|
10 participants
|
20 participants
|
20 participants
|
22 participants
|
18 participants
|
SECONDARY outcome
Timeframe: Week 1, Week 2, Week 4, Week 8, Week 12Population: mITT population
Mean change from baseline in number of molluscum contagiosum lesions at each visit
Outcome measures
| Measure |
Cohort 1: SB206 4% BID
n=38 Participants
SB206 4% topically twice daily
|
Cohort 2: SB206 8% BID
n=39 Participants
SB206 8% topically twice daily
|
Cohort 3: SB206 12% BID
n=37 Participants
SB206 12% topically twice daily
|
Cohort 4: SB206 12% QD
n=43 Participants
SB206 12% topically once daily.
|
Placebo (Vehicle Gel)
n=60 Participants
Vehicle Gel topically once or twice daily
|
|---|---|---|---|---|---|
|
Mean Change in Molluscum Contagiosum at Each Visit
Week 1
|
-1.5 Molluscum lesion counts
Standard Error 1.43
|
0 Molluscum lesion counts
Standard Error 1.33
|
-2.5 Molluscum lesion counts
Standard Error 1.44
|
-4.0 Molluscum lesion counts
Standard Error 1.27
|
0.7 Molluscum lesion counts
Standard Error 1.13
|
|
Mean Change in Molluscum Contagiosum at Each Visit
Week 2
|
-1.9 Molluscum lesion counts
Standard Error 1.53
|
-1.7 Molluscum lesion counts
Standard Error 1.45
|
-1.8 Molluscum lesion counts
Standard Error 1.57
|
-7.1 Molluscum lesion counts
Standard Error 1.41
|
-1.2 Molluscum lesion counts
Standard Error 1.23
|
|
Mean Change in Molluscum Contagiosum at Each Visit
Week 4
|
-1.8 Molluscum lesion counts
Standard Error 1.80
|
-6.0 Molluscum lesion counts
Standard Error 1.71
|
-6.2 Molluscum lesion counts
Standard Error 1.82
|
-8.7 Molluscum lesion counts
Standard Error 1.66
|
-0.9 Molluscum lesion counts
Standard Error 1.43
|
|
Mean Change in Molluscum Contagiosum at Each Visit
Week 8
|
-5.6 Molluscum lesion counts
Standard Error 2.08
|
-10.3 Molluscum lesion counts
Standard Error 2.00
|
-7.6 Molluscum lesion counts
Standard Error 2.10
|
-12.3 Molluscum lesion counts
Standard Error 1.92
|
-4.9 Molluscum lesion counts
Standard Error 1.65
|
|
Mean Change in Molluscum Contagiosum at Each Visit
Week 12
|
-7.2 Molluscum lesion counts
Standard Error 2.43
|
-12.0 Molluscum lesion counts
Standard Error 2.31
|
-9.9 Molluscum lesion counts
Standard Error 2.42
|
-12.9 Molluscum lesion counts
Standard Error 2.21
|
-8.6 Molluscum lesion counts
Standard Error 1.90
|
SECONDARY outcome
Timeframe: Week 1, Week 2, Week 4, Week 8, Week 12Population: mITT population
Percent change from baseline in number of molluscum contagiosum lesions at each visit
Outcome measures
| Measure |
Cohort 1: SB206 4% BID
n=38 Participants
SB206 4% topically twice daily
|
Cohort 2: SB206 8% BID
n=39 Participants
SB206 8% topically twice daily
|
Cohort 3: SB206 12% BID
n=37 Participants
SB206 12% topically twice daily
|
Cohort 4: SB206 12% QD
n=43 Participants
SB206 12% topically once daily.
|
Placebo (Vehicle Gel)
n=60 Participants
Vehicle Gel topically once or twice daily
|
|---|---|---|---|---|---|
|
Percent Change in Molluscum Contagiosum at Each Visit
Week 2
|
-4.4 Percentage change from baseline
Standard Error 8.44
|
5.8 Percentage change from baseline
Standard Error 8.07
|
-5.9 Percentage change from baseline
Standard Error 8.64
|
-29.2 Percentage change from baseline
Standard Error 7.81
|
-4.1 Percentage change from baseline
Standard Error 6.77
|
|
Percent Change in Molluscum Contagiosum at Each Visit
Week 12
|
-25.3 Percentage change from baseline
Standard Error 9.65
|
-64.3 Percentage change from baseline
Standard Error 9.07
|
-56.1 Percentage change from baseline
Standard Error 9.61
|
-54.6 Percentage change from baseline
Standard Error 8.70
|
-37.8 Percentage change from baseline
Standard Error 7.54
|
|
Percent Change in Molluscum Contagiosum at Each Visit
Week 1
|
0.0 Percentage change from baseline
Standard Error 7.82
|
10.1 Percentage change from baseline
Standard Error 7.33
|
-4.7 Percentage change from baseline
Standard Error 7.84
|
-11.1 Percentage change from baseline
Standard Error 6.96
|
8.7 Percentage change from baseline
Standard Error 6.16
|
|
Percent Change in Molluscum Contagiosum at Each Visit
Week 4
|
-3.6 Percentage change from baseline
Standard Error 8.19
|
-30.4 Percentage change from baseline
Standard Error 7.75
|
-29.2 Percentage change from baseline
Standard Error 8.32
|
-37.3 Percentage change from baseline
Standard Error 7.54
|
-6.6 Percentage change from baseline
Standard Error 6.51
|
|
Percent Change in Molluscum Contagiosum at Each Visit
Week 8
|
-19.2 Percentage change from baseline
Standard Error 9.54
|
-47.5 Percentage change from baseline
Standard Error 9.17
|
-38.7 Percentage change from baseline
Standard Error 9.64
|
-56.3 Percentage change from baseline
Standard Error 8.79
|
-17.2 Percentage change from baseline
Standard Error 7.58
|
Adverse Events
Cohort 1: SB206 4% BID
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 2: SB206 8% BID
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Cohort 3: SB206 12% BID
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Cohort 4: SB206 12% QD
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Placebo (Vehicle Gel)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1: SB206 4% BID
n=46 participants at risk
SB206 4% topically twice daily
|
Cohort 2: SB206 8% BID
n=48 participants at risk
SB206 8% topically twice daily
|
Cohort 3: SB206 12% BID
n=47 participants at risk
SB206 12%: topically twice daily
|
Cohort 4: SB206 12% QD
n=47 participants at risk
SB206 12% topically once daily
|
Placebo (Vehicle Gel)
n=66 participants at risk
Vehicle Gel topically once or twice daily
|
|---|---|---|---|---|---|
|
General disorders
Application site erythema
|
6.5%
3/46 • Baseline visit to end of study visit, 85 days.
The at risk population is based on the Safety Population. Only TEAEs were to be considered.
|
12.5%
6/48 • Baseline visit to end of study visit, 85 days.
The at risk population is based on the Safety Population. Only TEAEs were to be considered.
|
12.8%
6/47 • Baseline visit to end of study visit, 85 days.
The at risk population is based on the Safety Population. Only TEAEs were to be considered.
|
10.6%
5/47 • Baseline visit to end of study visit, 85 days.
The at risk population is based on the Safety Population. Only TEAEs were to be considered.
|
0.00%
0/66 • Baseline visit to end of study visit, 85 days.
The at risk population is based on the Safety Population. Only TEAEs were to be considered.
|
|
General disorders
Application site pain
|
4.3%
2/46 • Baseline visit to end of study visit, 85 days.
The at risk population is based on the Safety Population. Only TEAEs were to be considered.
|
6.2%
3/48 • Baseline visit to end of study visit, 85 days.
The at risk population is based on the Safety Population. Only TEAEs were to be considered.
|
6.4%
3/47 • Baseline visit to end of study visit, 85 days.
The at risk population is based on the Safety Population. Only TEAEs were to be considered.
|
8.5%
4/47 • Baseline visit to end of study visit, 85 days.
The at risk population is based on the Safety Population. Only TEAEs were to be considered.
|
0.00%
0/66 • Baseline visit to end of study visit, 85 days.
The at risk population is based on the Safety Population. Only TEAEs were to be considered.
|
|
General disorders
Pyrexia
|
2.2%
1/46 • Baseline visit to end of study visit, 85 days.
The at risk population is based on the Safety Population. Only TEAEs were to be considered.
|
10.4%
5/48 • Baseline visit to end of study visit, 85 days.
The at risk population is based on the Safety Population. Only TEAEs were to be considered.
|
2.1%
1/47 • Baseline visit to end of study visit, 85 days.
The at risk population is based on the Safety Population. Only TEAEs were to be considered.
|
2.1%
1/47 • Baseline visit to end of study visit, 85 days.
The at risk population is based on the Safety Population. Only TEAEs were to be considered.
|
3.0%
2/66 • Baseline visit to end of study visit, 85 days.
The at risk population is based on the Safety Population. Only TEAEs were to be considered.
|
|
General disorders
Application site exfoliation
|
0.00%
0/46 • Baseline visit to end of study visit, 85 days.
The at risk population is based on the Safety Population. Only TEAEs were to be considered.
|
2.1%
1/48 • Baseline visit to end of study visit, 85 days.
The at risk population is based on the Safety Population. Only TEAEs were to be considered.
|
6.4%
3/47 • Baseline visit to end of study visit, 85 days.
The at risk population is based on the Safety Population. Only TEAEs were to be considered.
|
8.5%
4/47 • Baseline visit to end of study visit, 85 days.
The at risk population is based on the Safety Population. Only TEAEs were to be considered.
|
0.00%
0/66 • Baseline visit to end of study visit, 85 days.
The at risk population is based on the Safety Population. Only TEAEs were to be considered.
|
|
General disorders
Application site pruritus
|
2.2%
1/46 • Baseline visit to end of study visit, 85 days.
The at risk population is based on the Safety Population. Only TEAEs were to be considered.
|
2.1%
1/48 • Baseline visit to end of study visit, 85 days.
The at risk population is based on the Safety Population. Only TEAEs were to be considered.
|
8.5%
4/47 • Baseline visit to end of study visit, 85 days.
The at risk population is based on the Safety Population. Only TEAEs were to be considered.
|
4.3%
2/47 • Baseline visit to end of study visit, 85 days.
The at risk population is based on the Safety Population. Only TEAEs were to be considered.
|
0.00%
0/66 • Baseline visit to end of study visit, 85 days.
The at risk population is based on the Safety Population. Only TEAEs were to be considered.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/46 • Baseline visit to end of study visit, 85 days.
The at risk population is based on the Safety Population. Only TEAEs were to be considered.
|
6.2%
3/48 • Baseline visit to end of study visit, 85 days.
The at risk population is based on the Safety Population. Only TEAEs were to be considered.
|
0.00%
0/47 • Baseline visit to end of study visit, 85 days.
The at risk population is based on the Safety Population. Only TEAEs were to be considered.
|
2.1%
1/47 • Baseline visit to end of study visit, 85 days.
The at risk population is based on the Safety Population. Only TEAEs were to be considered.
|
1.5%
1/66 • Baseline visit to end of study visit, 85 days.
The at risk population is based on the Safety Population. Only TEAEs were to be considered.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/46 • Baseline visit to end of study visit, 85 days.
The at risk population is based on the Safety Population. Only TEAEs were to be considered.
|
6.2%
3/48 • Baseline visit to end of study visit, 85 days.
The at risk population is based on the Safety Population. Only TEAEs were to be considered.
|
2.1%
1/47 • Baseline visit to end of study visit, 85 days.
The at risk population is based on the Safety Population. Only TEAEs were to be considered.
|
4.3%
2/47 • Baseline visit to end of study visit, 85 days.
The at risk population is based on the Safety Population. Only TEAEs were to be considered.
|
1.5%
1/66 • Baseline visit to end of study visit, 85 days.
The at risk population is based on the Safety Population. Only TEAEs were to be considered.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/46 • Baseline visit to end of study visit, 85 days.
The at risk population is based on the Safety Population. Only TEAEs were to be considered.
|
6.2%
3/48 • Baseline visit to end of study visit, 85 days.
The at risk population is based on the Safety Population. Only TEAEs were to be considered.
|
0.00%
0/47 • Baseline visit to end of study visit, 85 days.
The at risk population is based on the Safety Population. Only TEAEs were to be considered.
|
0.00%
0/47 • Baseline visit to end of study visit, 85 days.
The at risk population is based on the Safety Population. Only TEAEs were to be considered.
|
3.0%
2/66 • Baseline visit to end of study visit, 85 days.
The at risk population is based on the Safety Population. Only TEAEs were to be considered.
|
Additional Information
Cathy White, Vice President, Drug Development Operations
Novan
Phone: 9194858080
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The PI must wait 18 months after the closeout of the trial at all Study sites or until the publication of the multi-site Sponsor results. The only restriction on PI publication after that time is that the sponsor can review results communications prior to public release and can request confidential or proprietary information be removed or can embargo communications regarding trial results for a period that is more than 90 days but less than 120 days.
- Publication restrictions are in place
Restriction type: OTHER