Trial Outcomes & Findings for A Phase 3 Molluscum Contagiosum Efficacy and Safety Study (NCT NCT04535531)
NCT ID: NCT04535531
Last Updated: 2023-01-26
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
891 participants
Primary outcome timeframe
12 Weeks
Results posted on
2023-01-26
Participant Flow
Subjects receiving current treatment for MC at the time of the Screening Visit entered a wash out period of up to 14 days prior to randomization.
Participant milestones
| Measure |
SB206 10.3% Berdazimer
SB206 10.3% berdazimer topically once daily
SB206 10.3% berdazimer: Topically once daily
|
Vehicle Gel
Vehicle gel topically once daily
vehicle gel: Topically once daily
|
|---|---|---|
|
Overall Study
STARTED
|
444
|
447
|
|
Overall Study
COMPLETED
|
363
|
390
|
|
Overall Study
NOT COMPLETED
|
81
|
57
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 3 Molluscum Contagiosum Efficacy and Safety Study
Baseline characteristics by cohort
| Measure |
SB206 10.3% Berdazimer
n=444 Participants
SB206 10.3% berdazimer topically once daily
SB206 10.3% berdazimer: Topically once daily
|
Vehicle Gel
n=447 Participants
Vehicle gel topically once daily
vehicle gel: Topically once daily
|
Total
n=891 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<1 year old
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
891 participants
n=5 Participants
|
|
Age, Customized
1 to <2 years old
|
15 participants
n=5 Participants
|
12 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Age, Customized
2 years old to <6 years old
|
220 participants
n=5 Participants
|
213 participants
n=7 Participants
|
433 participants
n=5 Participants
|
|
Age, Customized
6 years old to <12 years old
|
178 participants
n=5 Participants
|
201 participants
n=7 Participants
|
379 participants
n=5 Participants
|
|
Age, Customized
12 years old to <18 years old
|
24 participants
n=5 Participants
|
15 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Age, Customized
18 years old
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
216 Participants
n=5 Participants
|
234 Participants
n=7 Participants
|
450 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
228 Participants
n=5 Participants
|
213 Participants
n=7 Participants
|
441 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
94 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
345 Participants
n=5 Participants
|
357 Participants
n=7 Participants
|
702 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity Not Reported
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
21 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
387 Participants
n=5 Participants
|
382 Participants
n=7 Participants
|
769 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than One Race
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race Not Reported
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
444 participants
n=5 Participants
|
447 participants
n=7 Participants
|
891 participants
n=5 Participants
|
|
Baseline number of Molluscum lesions
|
23.1 Molluscum lesions
STANDARD_DEVIATION 17.60 • n=5 Participants
|
20.5 Molluscum lesions
STANDARD_DEVIATION 16.18 • n=7 Participants
|
21.8 Molluscum lesions
STANDARD_DEVIATION 16.94 • 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=444 Participants
SB206 gel applied topically, once daily for 12 weeks.
|
Placebo
n=447 Participants
Placebo gel applied topically, once daily for 12 weeks.
|
|---|---|---|
|
Complete Clearance of All Treatable MC at Week 12
|
144 Participants
|
88 Participants
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: ITT
Percent (proportion) of subjects achieving a lesion count of 0 or 1 of all treatable MC at Week 12.
Outcome measures
| Measure |
SB206
n=444 Participants
SB206 gel applied topically, once daily for 12 weeks.
|
Placebo
n=447 Participants
Placebo gel applied topically, once daily for 12 weeks.
|
|---|---|---|
|
A Lesion Count of 0 or 1 of All Treatable MC at Week 12
|
193 Participants
|
110 Participants
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: ITT
Percent (proportion) of subjects achieving at least a 90% reduction from Baseline in the number of all treatable MC at Week 12
Outcome measures
| Measure |
SB206
n=444 Participants
SB206 gel applied topically, once daily for 12 weeks.
|
Placebo
n=447 Participants
Placebo gel applied topically, once daily for 12 weeks.
|
|---|---|---|
|
90% Reduction From Baseline in the Number of All Treatable MC at Week 12
|
191 Participants
|
107 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=444 Participants
SB206 gel applied topically, once daily for 12 weeks.
|
Placebo
n=447 Participants
Placebo gel applied topically, once daily for 12 weeks.
|
|---|---|---|
|
Complete Clearance of All Treatable MC at Week 8
|
87 Participants
|
52 Participants
|
SECONDARY outcome
Timeframe: 4 WeeksPopulation: ITT
Percent change from Baseline in the number of all treatable MC at Week 4
Outcome measures
| Measure |
SB206
n=444 Participants
SB206 gel applied topically, once daily for 12 weeks.
|
Placebo
n=447 Participants
Placebo gel applied topically, once daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in the Number of All Treatable MC at Week 4
|
-25.5 percentage of change from baseline
Standard Error 2.86
|
-9.2 percentage of change from baseline
Standard Error 2.86
|
Adverse Events
SB206
Serious events: 0 serious events
Other events: 221 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SB206
n=444 participants at risk
SB206 gel applied topically, once daily for 12 weeks.
|
Placebo
n=447 participants at risk
Placebo gel applied topically, once daily for 12 weeks.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Supracondylar Fracture of right humerus, closed reduction
|
0.00%
0/444 • Baseline visit to end of study visit, 84 days.
Only TEAE were to be considered.
|
0.22%
1/447 • Number of events 1 • Baseline visit to end of study visit, 84 days.
Only TEAE were to be considered.
|
Other adverse events
| Measure |
SB206
n=444 participants at risk
SB206 gel applied topically, once daily for 12 weeks.
|
Placebo
n=447 participants at risk
Placebo gel applied topically, once daily for 12 weeks.
|
|---|---|---|
|
General disorders
Application site pain
|
18.7%
83/444 • Number of events 113 • Baseline visit to end of study visit, 84 days.
Only TEAE were to be considered.
|
5.1%
23/447 • Number of events 26 • Baseline visit to end of study visit, 84 days.
Only TEAE were to be considered.
|
|
General disorders
Application site erythema
|
11.7%
52/444 • Number of events 66 • Baseline visit to end of study visit, 84 days.
Only TEAE were to be considered.
|
1.3%
6/447 • Number of events 7 • Baseline visit to end of study visit, 84 days.
Only TEAE were to be considered.
|
|
General disorders
Application site pruritus
|
7.4%
33/444 • Number of events 38 • Baseline visit to end of study visit, 84 days.
Only TEAE were to be considered.
|
1.1%
5/447 • Number of events 5 • Baseline visit to end of study visit, 84 days.
Only TEAE were to be considered.
|
|
General disorders
Application site exfoliation
|
6.1%
27/444 • Number of events 45 • Baseline visit to end of study visit, 84 days.
Only TEAE were to be considered.
|
0.00%
0/447 • Baseline visit to end of study visit, 84 days.
Only TEAE were to be considered.
|
|
General disorders
Application site dermatitis
|
5.9%
26/444 • Number of events 28 • Baseline visit to end of study visit, 84 days.
Only TEAE were to be considered.
|
0.67%
3/447 • Number of events 3 • 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