Trial Outcomes & Findings for A Phase 3 Randomized Parallel Group Study Comparing the Efficacy & Safety of SB206 & Vehicle Gel in the Treatment of MC (B-SIMPLE1) (NCT NCT03927716)
NCT ID: NCT03927716
Last Updated: 2022-12-27
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
PHASE3
Target enrollment
352 participants
Primary outcome timeframe
12 Weeks
Results posted on
2022-12-27
Participant Flow
The recruitment period began June 3, 2019 and ended on August 2, 2019.
Subjects receiving current treatment for MC at the time of the Screening Visit will enter a wash out period of up to 14 days prior to randomization.
Participant milestones
| Measure |
SB206 12%
SB206 12% topically once daily
SB206 12%: Topically once daily
|
Placebo
Placebo topically once daily
Placebo: Topically once daily
|
|---|---|---|
|
Overall Study
STARTED
|
236
|
116
|
|
Overall Study
COMPLETED
|
192
|
106
|
|
Overall Study
NOT COMPLETED
|
44
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 3 Randomized Parallel Group Study Comparing the Efficacy & Safety of SB206 & Vehicle Gel in the Treatment of MC (B-SIMPLE1)
Baseline characteristics by cohort
| Measure |
SB206 12%
n=235 Participants
SB206 12% topically once daily
SB206 12%: Topically once daily
|
Placebo
n=116 Participants
Placebo topically once daily
Placebo: Topically once daily
|
Total
n=351 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<1 year old
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Age, Customized
1 to 2 years old
|
8 participants
n=5 Participants
|
1 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Age, Customized
2 years old to 6 years old
|
99 participants
n=5 Participants
|
59 participants
n=7 Participants
|
158 participants
n=5 Participants
|
|
Age, Customized
6 years old to 12 years old
|
105 participants
n=5 Participants
|
47 participants
n=7 Participants
|
152 participants
n=5 Participants
|
|
Age, Customized
12 years old to 18 years old
|
17 participants
n=5 Participants
|
7 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Age, Customized
18 years old
|
6 participants
n=5 Participants
|
2 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
119 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
168 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
116 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
183 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
69 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
166 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
249 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
206 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
306 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
235 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
351 Participants
n=5 Participants
|
|
Baseline number of Molluscum lesions
|
17.8 Molluscum lesions
STANDARD_DEVIATION 13.87 • n=5 Participants
|
18.6 Molluscum lesions
STANDARD_DEVIATION 15.41 • n=7 Participants
|
18.1 Molluscum lesions
STANDARD_DEVIATION 14.38 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 WeeksPopulation: ITT
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 |
SB206
n=236 Participants
SB206 gel applied topically, once a day for 12 weeks.
|
Placebo
n=116 Participants
Placebo gel applied topically, once a day for 12 weeks.
|
|---|---|---|
|
Complete Clearance of All Treatable MC at Week 12
|
61 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: 8 WeeksPopulation: ITT
Percent (proportion) of subjects with complete clearance of all treatable MC at Week 8. This was measured by dividing the number of subjects who showed complete clearance at week 8 by the number in that treatment group (this represents our secondary outcome variable).
Outcome measures
| Measure |
SB206
n=236 Participants
SB206 gel applied topically, once a day for 12 weeks.
|
Placebo
n=116 Participants
Placebo gel applied topically, once a day for 12 weeks.
|
|---|---|---|
|
Complete Clearance of All Treatable MC at Week 8
|
36 Participants
|
12 Participants
|
Adverse Events
SB206
Serious events: 0 serious events
Other events: 86 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SB206
n=235 participants at risk
SB206 gel applied every day for 12 weeks.
|
Placebo
n=116 participants at risk
Placebo gel applied every day for 12 weeks.
|
|---|---|---|
|
General disorders
General disorders and administration site conditions
|
36.6%
86/235 • Number of events 113 • Baseline visit to end of study visit, 84 days.
Only TEAE were to be considered.
|
17.2%
20/116 • Number of events 21 • Baseline visit to end of study visit, 84 days.
Only TEAE were to be considered.
|
|
General disorders
Application site pain
|
21.7%
51/235 • Number of events 66 • Baseline visit to end of study visit, 84 days.
Only TEAE were to be considered.
|
6.9%
8/116 • Number of events 9 • Baseline visit to end of study visit, 84 days.
Only TEAE were to be considered.
|
|
General disorders
Application site erythema
|
12.3%
29/235 • Number of events 41 • Baseline visit to end of study visit, 84 days.
Only TEAE were to be considered.
|
2.6%
3/116 • Number of events 3 • Baseline visit to end of study visit, 84 days.
Only TEAE were to be considered.
|
|
General disorders
Application site scar
|
2.6%
6/235 • Number of events 6 • Baseline visit to end of study visit, 84 days.
Only TEAE were to be considered.
|
7.8%
9/116 • Number of events 9 • Baseline visit to end of study visit, 84 days.
Only TEAE were to be considered.
|
Additional Information
Cathy White, Vice President, Drug Development Operations
Novan
Phone: 919-485-8080
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