Trial Outcomes & Findings for A Phase 3 Efficacy & Safety of SB206 & Vehicle Gel for the Treatment of MC (NCT NCT03927703)
NCT ID: NCT03927703
Last Updated: 2023-03-23
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
355 participants
Primary outcome timeframe
12 Weeks
Results posted on
2023-03-23
Participant Flow
The recruitment period began June 13, 2019 and ended on August 12, 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 Comparator
Placebo topically once daily
Placebo: Topically once daily
|
|---|---|---|
|
Overall Study
STARTED
|
237
|
118
|
|
Overall Study
COMPLETED
|
192
|
102
|
|
Overall Study
NOT COMPLETED
|
45
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 3 Efficacy & Safety of SB206 & Vehicle Gel for the Treatment of MC
Baseline characteristics by cohort
| Measure |
SB206 12%
n=237 Participants
SB206 12% topically once daily
SB206 12%: Topically once daily
|
Placebo Comparator
n=118 Participants
Placebo topically once daily
Placebo: Topically once daily
|
Total
n=355 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<1 year old
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
355 participants
n=5 Participants
|
|
Age, Customized
1 to 2 years old
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Age, Customized
2 years old to 6 years old
|
116 participants
n=5 Participants
|
60 participants
n=7 Participants
|
176 participants
n=5 Participants
|
|
Age, Customized
6 years old to 12 years old
|
108 participants
n=5 Participants
|
46 participants
n=7 Participants
|
154 participants
n=5 Participants
|
|
Age, Customized
12 years old to 18 years old
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Age, Customized
18 years old
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
110 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
127 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
183 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
32 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
202 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
298 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
221 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
325 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than One Race
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
237 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
354 Participants
n=5 Participants
|
|
Baseline number of Molluscum lesions
|
18.9 Molluscum lesions
STANDARD_DEVIATION 14.46 • n=5 Participants
|
17.1 Molluscum lesions
STANDARD_DEVIATION 12.82 • n=7 Participants
|
18.3 Molluscum lesions
STANDARD_DEVIATION 13.95 • 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=237 Participants
SB206 applied every day for 12 weeks.
|
Placebo
n=118 Participants
Placebo gel applied every day for 12 weeks.
|
|---|---|---|
|
Complete Clearance of All Treatable MC at Week 12
|
71 Participants
|
24 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=237 Participants
SB206 applied every day for 12 weeks.
|
Placebo
n=118 Participants
Placebo gel applied every day for 12 weeks.
|
|---|---|---|
|
Complete Clearance of All Treatable MC at Week 8
|
33 Participants
|
7 Participants
|
Adverse Events
SB206 12%
Serious events: 1 serious events
Other events: 63 other events
Deaths: 0 deaths
Placebo Comparator
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SB206 12%
n=237 participants at risk
SB206 12%: Topically once daily
|
Placebo Comparator
n=117 participants at risk
Placebo: Topically once daily
|
|---|---|---|
|
Infections and infestations
Cellulitis
|
0.42%
1/237 • Number of events 1 • Baseline visit to end of study visit, 84 days.
Only TEAEs were to be considered. Adverse Events were reported for the Safety Population, which consisted of all subjects who received at least 1 application of study medication. There were 237 subjects in the SB206 QD group and 117 subjects in the Placebo group in the Safety Population.
|
0.85%
1/117 • Number of events 3 • Baseline visit to end of study visit, 84 days.
Only TEAEs were to be considered. Adverse Events were reported for the Safety Population, which consisted of all subjects who received at least 1 application of study medication. There were 237 subjects in the SB206 QD group and 117 subjects in the Placebo group in the Safety Population.
|
Other adverse events
| Measure |
SB206 12%
n=237 participants at risk
SB206 12%: Topically once daily
|
Placebo Comparator
n=117 participants at risk
Placebo: Topically once daily
|
|---|---|---|
|
General disorders
Application Site Pain
|
15.6%
37/237 • Baseline visit to end of study visit, 84 days.
Only TEAEs were to be considered. Adverse Events were reported for the Safety Population, which consisted of all subjects who received at least 1 application of study medication. There were 237 subjects in the SB206 QD group and 117 subjects in the Placebo group in the Safety Population.
|
0.00%
0/117 • Baseline visit to end of study visit, 84 days.
Only TEAEs were to be considered. Adverse Events were reported for the Safety Population, which consisted of all subjects who received at least 1 application of study medication. There were 237 subjects in the SB206 QD group and 117 subjects in the Placebo group in the Safety Population.
|
|
General disorders
Application site erythema
|
11.0%
26/237 • Baseline visit to end of study visit, 84 days.
Only TEAEs were to be considered. Adverse Events were reported for the Safety Population, which consisted of all subjects who received at least 1 application of study medication. There were 237 subjects in the SB206 QD group and 117 subjects in the Placebo group in the Safety Population.
|
0.00%
0/117 • Baseline visit to end of study visit, 84 days.
Only TEAEs were to be considered. Adverse Events were reported for the Safety Population, which consisted of all subjects who received at least 1 application of study medication. There were 237 subjects in the SB206 QD group and 117 subjects in the Placebo group in the Safety Population.
|
|
General disorders
Application site scar
|
0.00%
0/237 • Baseline visit to end of study visit, 84 days.
Only TEAEs were to be considered. Adverse Events were reported for the Safety Population, which consisted of all subjects who received at least 1 application of study medication. There were 237 subjects in the SB206 QD group and 117 subjects in the Placebo group in the Safety Population.
|
8.5%
10/117 • Baseline visit to end of study visit, 84 days.
Only TEAEs were to be considered. Adverse Events were reported for the Safety Population, which consisted of all subjects who received at least 1 application of study medication. There were 237 subjects in the SB206 QD group and 117 subjects in the Placebo group in the Safety Population.
|
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