Trial · NCT03436615
A Study to Evaluate the Safety and Efficacy of SB206 in Subjects With Molluscum Contagiosum
NCT03436615, Phase 2, Completed, Novan, Inc.; results first posted 2023-05-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate the Safety and Efficacy of SB206 in Subjects With Molluscum Contagiosum. Trials, record NCT03436615. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03436615
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Safety and Efficacy of SB206 in Subjects With Molluscum Contagiosum
- NCT number
- NCT03436615
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 256 participants, actual
- Lead sponsor
- Novan, Inc.
- Conditions
- Molluscum Contagiosum
- Interventions
- SB206 4%, SB206 8%, SB206 12%, Placebo
- First posted
- 2018-02-19
- Last updated
- 2023-05-06
- Results first posted
- 2023-05-06
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Subjects Achieving Complete Clearance at Week 12 | 12 weeks | 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). |
| Secondary | Proportion of Subjects Achieving Complete Clearance at Each Visit | Week 1; Week 2; Week 4; Week 8; Week 12 | Proportion of subjects achieving complete clearance of all treated molluscum contagiosum lesions at each visit. |
| Secondary | Time to First Complete Clearance | Week 12 | Median time to reach first complete clearance of all molluscum contagiosum lesions (Kaplan-Meier estimate) |
| Secondary | Proportion of Subjects Achieving 75% Reduction at Each Visit | Week 1, Week 2, Week 4, Week 8, Week 12 | Proportion of subjects achieving 75% reduction from baseline in number of molluscum contagiosum at each visit |
| Secondary | Mean Change in Molluscum Contagiosum at Each Visit | Week 1, Week 2, Week 4, Week 8, Week 12 | Mean change from baseline in number of molluscum contagiosum lesions at each visit |
| Secondary | Percent Change in Molluscum Contagiosum at Each Visit | Week 1, Week 2, Week 4, Week 8, Week 12 | Percent change from baseline in number of molluscum contagiosum lesions at each visit |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Subjects Achieving Complete Clearance at Week 12 | 12 weeks | mITT Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Subjects Achieving Complete Clearance at Each Visit | Week 1; Week 2; Week 4; Week 8; Week 12 | mITT population | participants | NUMBER |
| SECONDARY | Time to First Complete Clearance | Week 12 | mITT | Days | MEDIAN |
| SECONDARY | Proportion of Subjects Achieving 75% Reduction at Each Visit | Week 1, Week 2, Week 4, Week 8, Week 12 | mITT population. | participants | NUMBER |
| SECONDARY | Mean Change in Molluscum Contagiosum at Each Visit | Week 1, Week 2, Week 4, Week 8, Week 12 | mITT population | Molluscum lesion counts | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change in Molluscum Contagiosum at Each Visit | Week 1, Week 2, Week 4, Week 8, Week 12 | mITT population | Percentage change from baseline | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group110
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Subjects Achieving Complete Clearance at Week 12 | Cohort 1: SB206 4% BID | 5 | Participants | ||
| Proportion of Subjects Achieving Complete Clearance at Week 12 | Cohort 2: SB206 8% BID | 16 | Participants | ||
| Proportion of Subjects Achieving Complete Clearance at Week 12 | Cohort 3: SB206 12% BID | 13 | Participants | ||
| Proportion of Subjects Achieving Complete Clearance at Week 12 | Cohort 4: SB206 12% QD | 18 | Participants | ||
| Proportion of Subjects Achieving Complete Clearance at Week 12 | Placebo (Vehicle Gel) | 12 | Participants | ||
| Proportion of Subjects Achieving Complete Clearance at Each Visit | Cohort 1: SB206 4% BID | Week 1 proportion of subjects achieving complete clearance. | 0 | participants | |
| Proportion of Subjects Achieving Complete Clearance at Each Visit | Cohort 2: SB206 8% BID | Week 1 proportion of subjects achieving complete clearance. | 1 | participants | |
| Proportion of Subjects Achieving Complete Clearance at Each Visit | Cohort 3: SB206 12% BID | Week 1 proportion of subjects achieving complete clearance. | 0 | participants | |
| Proportion of Subjects Achieving Complete Clearance at Each Visit | Cohort 4: SB206 12% QD | Week 1 proportion of subjects achieving complete clearance. | 1 | participants | |
| Proportion of Subjects Achieving Complete Clearance at Each Visit | Placebo (Vehicle Gel) | Week 1 proportion of subjects achieving complete clearance. | 0 | participants |
1 to 10 of 110Source ClinicalTrials.gov
See all 110 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1: SB206 4% BID | 47 | |
| Overall Study | STARTED | Cohort 2: SB206 8% BID | 48 | |
| Overall Study | STARTED | Cohort 3: SB206 12% BID | 47 | |
| Overall Study | STARTED | Cohort 4: SB206 12% QD | 48 | |
| Overall Study | STARTED | Placebo (Vehicle Gel) | 66 | |
| Overall Study | COMPLETED | Cohort 1: SB206 4% BID | 38 | |
| Overall Study | COMPLETED | Cohort 2: SB206 8% BID | 40 | |
| Overall Study | COMPLETED | Cohort 3: SB206 12% BID | 39 | |
| Overall Study | COMPLETED | Cohort 4: SB206 12% QD | 43 | |
| Overall Study | COMPLETED | Placebo (Vehicle Gel) | 61 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events40
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Application site erythema | General disorders | Cohort 1: SB206 4% BID | 3 | 46 | |
| other | Application site erythema | General disorders | Cohort 2: SB206 8% BID | 6 | 48 | |
| other | Application site erythema | General disorders | Cohort 3: SB206 12% BID | 6 | 47 | |
| other | Application site erythema | General disorders | Cohort 4: SB206 12% QD | 5 | 47 | |
| other | Application site erythema | General disorders | Placebo (Vehicle Gel) | 0 | 66 | |
| other | Application site pain | General disorders | Cohort 1: SB206 4% BID | 2 | 46 | |
| other | Application site pain | General disorders | Cohort 2: SB206 8% BID | 3 | 48 | |
| other | Application site pain | General disorders | Cohort 3: SB206 12% BID | 3 | 47 | |
| other | Application site pain | General disorders | Cohort 4: SB206 12% QD | 4 | 47 | |
| other | Application site pain | General disorders | Placebo (Vehicle Gel) | 0 | 66 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1: SB206 4% BID | 0 | 46 |
| Total, all-cause mortality | Cohort 2: SB206 8% BID | 0 | 48 |
| Total, all-cause mortality | Cohort 3: SB206 12% BID | 0 | 47 |
| Total, all-cause mortality | Cohort 4: SB206 12% QD | 0 | 47 |
| Total, all-cause mortality | Placebo (Vehicle Gel) | 0 | 66 |
| Total, other adverse events | Cohort 1: SB206 4% BID | 7 | 46 |
| Total, other adverse events | Cohort 2: SB206 8% BID | 24 | 48 |
| Total, other adverse events | Cohort 3: SB206 12% BID | 18 | 47 |
| Total, other adverse events | Cohort 4: SB206 12% QD | 19 | 47 |
| Total, other adverse events | Placebo (Vehicle Gel) | 6 | 66 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03436615
GET https://conductscience.org/api/trials/v1/NCT03436615/results?page=2