Trial · NCT04535531

A Phase 3 Molluscum Contagiosum Efficacy and Safety Study

NCT04535531, Phase 3, Completed, Novan, Inc.; results first posted 2023-01-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Phase 3 Molluscum Contagiosum Efficacy and Safety Study. Trials, record NCT04535531. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04535531

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Phase 3 Molluscum Contagiosum Efficacy and Safety Study
NCT number: NCT04535531
Status: Completed
Phases: Phase 3
Enrollment: 891 participants, actual
Lead sponsor: Novan, Inc.
Conditions: Molluscum Contagiosum
Interventions: SB206 10.3% berdazimer, vehicle gel
First posted: 2020-09-02
Last updated: 2023-01-26
Results first posted: 2023-01-26

Source ClinicalTrials.gov

Registered outcomes5

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	A Lesion Count of 0 or 1 of All Treatable MC at Week 12	12 Weeks	Percent (proportion) of subjects achieving a lesion count of 0 or 1 of all treatable MC at Week 12.
Secondary	90% Reduction From Baseline in the Number of All Treatable MC at Week 12	12 Weeks	Percent (proportion) of subjects achieving at least a 90% reduction from Baseline in the number of all treatable MC at Week 12
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).
Secondary	Change From Baseline in the Number of All Treatable MC at Week 4	4 Weeks	Percent change from Baseline in the number of all treatable MC at Week 4

Source ClinicalTrials.gov

Outcomes5

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	A Lesion Count of 0 or 1 of All Treatable MC at Week 12	12 Weeks	ITT	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	90% Reduction From Baseline in the Number 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
SECONDARY	Change From Baseline in the Number of All Treatable MC at Week 4	4 Weeks	ITT	percentage of change from baseline	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Complete Clearance of All Treatable MC at Week 12	SB206	144		Participants
Complete Clearance of All Treatable MC at Week 12	Placebo	88		Participants
A Lesion Count of 0 or 1 of All Treatable MC at Week 12	SB206	193		Participants
A Lesion Count of 0 or 1 of All Treatable MC at Week 12	Placebo	110		Participants
90% Reduction From Baseline in the Number of All Treatable MC at Week 12	SB206	191		Participants
90% Reduction From Baseline in the Number of All Treatable MC at Week 12	Placebo	107		Participants
Complete Clearance of All Treatable MC at Week 8	SB206	87		Participants
Complete Clearance of All Treatable MC at Week 8	Placebo	52		Participants
Change From Baseline in the Number of All Treatable MC at Week 4	SB206	-25.5	Standard Error 2.86	percentage of change from baseline
Change From Baseline in the Number of All Treatable MC at Week 4	Placebo	-9.2	Standard Error 2.86	percentage of change from baseline

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	SB206 10.3% Berdazimer	444
Overall Study	STARTED	Vehicle Gel	447
Overall Study	COMPLETED	SB206 10.3% Berdazimer	363
Overall Study	COMPLETED	Vehicle Gel	390
Overall Study	NOT COMPLETED	SB206 10.3% Berdazimer	81
Overall Study	NOT COMPLETED	Vehicle Gel	57

Source ClinicalTrials.gov

Adverse events12

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 pain	General disorders	SB206	83	444	113
other	Application site pain	General disorders	Placebo	23	447	26
other	Application site erythema	General disorders	SB206	52	444	66
other	Application site erythema	General disorders	Placebo	6	447	7
other	Application site pruritus	General disorders	SB206	33	444	38
other	Application site pruritus	General disorders	Placebo	5	447	5
other	Application site exfoliation	General disorders	SB206	27	444	45
other	Application site exfoliation	General disorders	Placebo	0	447	0
other	Application site dermatitis	General disorders	SB206	26	444	28
other	Application site dermatitis	General disorders	Placebo	3	447	3

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	SB206	0	444
Total, all-cause mortality	Placebo	0	447
Total, other adverse events	SB206	221	444
Total, other adverse events	Placebo	37	447
Total, serious adverse events	SB206	0	444
Total, serious adverse events	Placebo	1	447

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
35830173	DERIVED	PubMed
36287306	DERIVED	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 comparisons6

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: A Lesion Count of 0 or 1 of All Treatable MC at Week 12	Trial comparisons
SB206 vs Placebo: 90% Reduction From Baseline in the Number of All Treatable MC at Week 12	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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT04535531

GET https://conductscience.org/api/trials/v1/NCT04535531/registered

API reference For AI assistants