Trial · NCT02667444

P3 Study Comparing Once Daily SB204 and Vehicle Gel in Acne

NCT02667444, Phase 3, Completed, Novan, Inc.; results first posted 2023-07-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. P3 Study Comparing Once Daily SB204 and Vehicle Gel in Acne. Trials, record NCT02667444. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02667444

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Trial

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

Title: P3 Study Comparing Once Daily SB204 and Vehicle Gel in Acne
NCT number: NCT02667444
Status: Completed
Phases: Phase 3
Enrollment: 1,330 participants, actual
Lead sponsor: Novan, Inc.
Conditions: Acne Vulgaris
Interventions: SB204 4%, Vehicle Gel
First posted: 2016-01-29
Last updated: 2023-07-24
Results first posted: 2023-07-24

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Absolute Change From Baseline in Inflammatory Lesion Counts	Baseline and Week 12	The absolute change from Baseline in inflammatory lesion counts was to be assessed on the face only (forehead, right and left cheeks, chin, and nose). Inflammatory lesions included papules, pustules, nodules, and cysts.
Primary	Absolute Change From Baseline in Non-inflammatory Lesion Counts	Baseline and Week 12	The absolute change from Baseline in non-inflammatory lesion counts was to be assessed on the face only (forehead, right and left cheeks, chin, and nose). Non-inflammatory lesions included open comedones (blackheads) and closed comedones (whiteheads).
Primary	Proportion of Subjects With Investigator Global Assessment (IGA) Success at Week 12	Week 12	Proportion of subjects with Investigator Global Assessment (IGA) Success at Week 12 is defined as an IGA score of 0 or 1 (Clear/Almost Clear) and at least a 2 grade improvement from Baseline. The IGA scale is as follows: Grade Description 0 Clear: Clear skin with no inflammatory or non-inflammatory lesions. 1. Almost clear: Rare non-inflammatory lesions with rare papules (papules may be resolving and hyperpigmented, though not pink-red). 2. Mild: Some non-inflammatory lesions with no more than a few inflammatory lesions. 3. Moderate: Up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than one nodulocystic lesion. 4. Severe: Up to many non-inflammatory and inflammatory lesions, but no more than a few nodulocystic lesions
Secondary	Percent Change in Inflammatory Lesion Count	Baseline and Week 12	The percent change from baseline in inflammatory lesion count
Secondary	Percent Change in Non-inflammatory Lesion Count	Baseline and Week 12	The percent change from baseline in non-inflammatory lesion count
Secondary	Time to Reduction in Inflammatory Lesion Count	Week 12	Median time to a 35% reduction (improvement) in inflammatory lesion count (Kaplan-Meier analysis)
Secondary	Time to Improvement in IGA	Week 12	Median time to a 2 or more grade improvement in IGA (Kaplan-Meier analysis)

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Absolute Change From Baseline in Inflammatory Lesion Counts	Baseline and Week 12	Intent to treat (ITT) population	inflammatory acne lesions	MEAN
PRIMARY	Absolute Change From Baseline in Non-inflammatory Lesion Counts	Baseline and Week 12	Intent to treat (ITT) population	non-inflammatory acne lesions	MEAN
PRIMARY	Proportion of Subjects With Investigator Global Assessment (IGA) Success at Week 12	Week 12	Intent to treat (ITT) population; subjects who had Week 12 (study completion) visits.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Percent Change in Inflammatory Lesion Count	Baseline and Week 12	Intent to treat (ITT) population	Percentage change from baseline	MEAN
SECONDARY	Percent Change in Non-inflammatory Lesion Count	Baseline and Week 12	Intent to treat (ITT) population	Percentage change from baseline	MEAN
SECONDARY	Time to Reduction in Inflammatory Lesion Count	Week 12	Intent to treat (ITT) population	Days	MEDIAN
SECONDARY	Time to Improvement in IGA	Week 12	Intent to treat (ITT) population--Overall number of participants analyzed = number of participants who achieved a 2 or more grade improvement in their IGA score. This was a Kaplan-Meier analysis; for both the SB204 4% and Vehicle Gel treatment groups, the median was not estimable due to \< 50% of subjects achieving a 2 or more grade improvement in their IGA score.	Days	NUMBER

Source ClinicalTrials.gov

Results by group18

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

Outcome	Group	Value	Spread	Units
Absolute Change From Baseline in Inflammatory Lesion Counts	SB204 4%	-13.1	Standard Deviation 10.27	inflammatory acne lesions
Absolute Change From Baseline in Inflammatory Lesion Counts	Vehicle Gel	-10.9	Standard Deviation 10.81	inflammatory acne lesions
Absolute Change From Baseline in Non-inflammatory Lesion Counts	SB204 4%	-15.3	Standard Deviation 14.30	non-inflammatory acne lesions
Absolute Change From Baseline in Non-inflammatory Lesion Counts	Vehicle Gel	-12.7	Standard Deviation 16.01	non-inflammatory acne lesions
Proportion of Subjects With Investigator Global Assessment (IGA) Success at Week 12	SB204 4%	120		Participants
Proportion of Subjects With Investigator Global Assessment (IGA) Success at Week 12	Vehicle Gel	89		Participants
Percent Change in Inflammatory Lesion Count	SB204 4%	-48.5	Standard Deviation 36.36	Percentage change from baseline
Percent Change in Inflammatory Lesion Count	Vehicle Gel	-39.2	Standard Deviation 38.20	Percentage change from baseline
Percent Change in Non-inflammatory Lesion Count	SB204 4%	-40.5	Standard Deviation 36.35	Percentage change from baseline
Percent Change in Non-inflammatory Lesion Count	Vehicle Gel	-33.1	Standard Deviation 39.59	Percentage change from baseline

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	SB204 4%	664
Overall Study	STARTED	Vehicle Gel	666
Overall Study	COMPLETED	SB204 4%	576
Overall Study	COMPLETED	Vehicle Gel	574
Overall Study	NOT COMPLETED	SB204 4%	88
Overall Study	NOT COMPLETED	Vehicle Gel	92

Source ClinicalTrials.gov

Adverse events20

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	SB204 4%	14	666
other	Application site pain	General disorders	Vehicle Gel	4	661
other	Application site erythema	General disorders	SB204 4%	10	666
other	Application site erythema	General disorders	Vehicle Gel	2	661
other	Nasopharyngitis	Infections and infestations	SB204 4%	15	666
other	Nasopharyngitis	Infections and infestations	Vehicle Gel	18	661
other	Headache	Nervous system disorders	SB204 4%	10	666
other	Headache	Nervous system disorders	Vehicle Gel	1	661
serious	Brain neoplasm benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	SB204 4%	1	666	1
serious	Brain neoplasm benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Vehicle Gel	0	661	0

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	SB204 4%	0	666
Total, all-cause mortality	Vehicle Gel	0	661
Total, other adverse events	SB204 4%	49	666
Total, other adverse events	Vehicle Gel	25	661
Total, serious adverse events	SB204 4%	1	666
Total, serious adverse events	Vehicle Gel	3	661

Source ClinicalTrials.gov

Papers0

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 comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
SB204 4% vs Vehicle Gel: Proportion of Subjects With Investigator Global Assessment (IGA) Success at Week 12	Trial comparisons
SB204 4% vs Vehicle Gel: deaths from any cause	Trial comparisons
SB204 4% vs Vehicle Gel: 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/NCT02667444

GET https://conductscience.org/api/trials/v1/NCT02667444/registered

API reference For AI assistants