Trial · NCT03927716
A Phase 3 Randomized Parallel Group Study Comparing the Efficacy & Safety of SB206 & Vehicle Gel in the Treatment of MC (B-SIMPLE1)
NCT03927716, Phase 3, Completed, Novan, Inc.; results first posted 2022-12-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 3 Randomized Parallel Group Study Comparing the Efficacy & Safety of SB206 & Vehicle Gel in the Treatment of MC (B-SIMPLE1). Trials, record NCT03927716. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03927716
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 3 Randomized Parallel Group Study Comparing the Efficacy & Safety of SB206 & Vehicle Gel in the Treatment of MC (B-SIMPLE1)
- NCT number
- NCT03927716
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 352 participants, actual
- Lead sponsor
- Novan, Inc.
- Conditions
- Molluscum Contagiosum
- Interventions
- SB206 12%, Placebo
- First posted
- 2019-04-25
- Last updated
- 2022-12-27
- Results first posted
- 2022-12-27
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Clearance of All Treatable MC 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 | Complete Clearance of All Treatable MC at Week 8 | 8 Weeks | 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). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Complete Clearance of All Treatable MC at Week 12 | 12 Weeks | ITT | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Complete Clearance of All Treatable MC at Week 8 | 8 Weeks | ITT | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Clearance of All Treatable MC at Week 12 | SB206 | 61 | Participants | ||
| Complete Clearance of All Treatable MC at Week 12 | Placebo | 25 | Participants | ||
| Complete Clearance of All Treatable MC at Week 8 | SB206 | 36 | Participants | ||
| Complete Clearance of All Treatable MC at Week 8 | Placebo | 12 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SB206 12% | 236 | |
| Overall Study | STARTED | Placebo | 116 | |
| Overall Study | COMPLETED | SB206 12% | 192 | |
| Overall Study | COMPLETED | Placebo | 106 | |
| Overall Study | NOT COMPLETED | SB206 12% | 44 | |
| Overall Study | NOT COMPLETED | Placebo | 10 |
Source ClinicalTrials.gov
Adverse events8
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 | General disorders and administration site conditions | General disorders | SB206 | 86 | 235 | 113 |
| other | General disorders and administration site conditions | General disorders | Placebo | 20 | 116 | 21 |
| other | Application site pain | General disorders | SB206 | 51 | 235 | 66 |
| other | Application site pain | General disorders | Placebo | 8 | 116 | 9 |
| other | Application site erythema | General disorders | SB206 | 29 | 235 | 41 |
| other | Application site erythema | General disorders | Placebo | 3 | 116 | 3 |
| other | Application site scar | General disorders | SB206 | 6 | 235 | 6 |
| other | Application site scar | General disorders | Placebo | 9 | 116 | 9 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SB206 | 0 | 235 |
| Total, all-cause mortality | Placebo | 0 | 116 |
| Total, other adverse events | SB206 | 86 | 235 |
| Total, other adverse events | Placebo | 20 | 116 |
| Total, serious adverse events | SB206 | 0 | 235 |
| Total, serious adverse events | Placebo | 0 | 116 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34909721 | DERIVED |
Source PubMed
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| SB206 vs Placebo: Complete Clearance of All Treatable MC at Week 8 | Trial comparisons |
| SB206 vs Placebo: Complete Clearance of All Treatable MC at Week 12 | Trial comparisons |
| SB206 vs Placebo: deaths from any cause | Trial comparisons |
| SB206 vs Placebo: serious adverse events | Trial comparisons |
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/NCT03927716
GET https://conductscience.org/api/trials/v1/NCT03927716/registered