Phase 3
N=1,330
P3 Study Comparing Once Daily SB204 and Vehicle Gel in Acne
Acne Vulgaris
Bottom Line
View on ClinicalTrials.gov: NCT02667444 ↗Enrolled (actual)
1,330
Serious AEs
0.3%
Results posted
Jul 2023
Primary outcome: Primary: Absolute Change From Baseline in Inflammatory Lesion Counts — -13.1; -10.9 inflammatory acne lesions
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- SB204 4% (Drug); Vehicle Gel (Drug)
- Age
- Pediatric, Adult, Older Adult · 9+ yrs
- Sex
- All
- Sponsor
- Novan, Inc.
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change From Baseline in Inflammatory Lesion Counts |
-13.1; -10.9 | — |
| PRIMARY Absolute Change From Baseline in Non-inflammatory Lesion Counts |
-15.3; -12.7 | — |
| PRIMARY Proportion of Subjects With Investigator Global Assessment (IGA) Success at Week 12 |
120; 89 | — |
| SECONDARY Percent Change in Inflammatory Lesion Count |
-48.5; -39.2 | — |
| SECONDARY Percent Change in Non-inflammatory Lesion Count |
-40.5; -33.1 | — |
| SECONDARY Time to Reduction in Inflammatory Lesion Count |
38.0; 56.0 | — |
| SECONDARY Time to Improvement in IGA |
85.0; 87.0; NA; NA; NA; NA | — |
Summary
This is a 12 week, multi-center, double-blinded, randomized, vehicle-controlled, parallel group, study to be conducted in approximately 1300 subjects with acne vulgaris in the US.
Eligibility Criteria
Inclusion Criteria
- Moderate to severe acne
- Minimum of 25 and no more than 70 non-inflammatory lesions (open and closed comedones) on the face
- Minimum of 20 and no more than 40 inflammatory lesions (papules and pustules)
Exclusion Criteria
- Women of child-bearing potential who are pregnant, nursing, considering becoming pregnant
- Any dermatologic condition that could interfere with clinical evaluations including severe, recalcitrant cystic acne
Data sourced from ClinicalTrials.gov (NCT02667444). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.