Phase 2
N=213
P2 Multi-center Study of SB204 Gel in the Treatment of Acne Vulgaris
Acne Vulgaris
Bottom Line
View on ClinicalTrials.gov: NCT02242760 ↗Enrolled (actual)
213
Serious AEs
0.5%
Results posted
May 2023
Primary outcome: Primary: Absolute Change in Inflammatory Lesion Counts — -7.7; -4.1; -11.2; -11.3 inflammatory acne lesions
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SB204 2% (Drug); SB204 4% (Drug); Vehicle Gel (Drug)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- Novan, Inc.
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change in Inflammatory Lesion Counts |
-7.7; -4.1; -11.2; -11.3; -10.4 | — |
| PRIMARY Absolute Change in Non-inflammatory Lesion Counts |
-8.4; -6.9; -12.3; -14.1; -11.1 | — |
| PRIMARY Proportion of Success According to the Dichotomized Investigator Global Assessment [IGA] at End of Treatment |
2; 2; 8; 6; 7 | — |
| SECONDARY Percent Change in Inflammatory Lesion Count From Baseline to Week 12 |
-26.2; -12.5; -41.9; -41.6; -42.1 | — |
| SECONDARY Percent Change in Non-inflammatory Lesion Count From Baseline to Week 12 |
-20.2; -14.3; -33.8; -36.8; -33.0 | — |
| SECONDARY Median Time to Improvement |
11.6; 2.0; 4.1; 4.0 | — |
Summary
This is a randomized, multi-center, double-blinded study in subjects with moderate to severe acne vulgaris. Subjects eligible to enroll will be treated once or twice daily with 2 concentrations of a topical drug in development or a vehicle. Subjects will be treated for up to 12 weeks.
Eligibility Criteria
Inclusion Criteria
- Moderate to severe acne
- 25-70 non-inflammatory lesions at Baseline
- 20-40 inflammatory lesions at Baseline
Exclusion Criteria
- Subjects with known allergy to any component of the test material or vehicle
- Women who are pregnant or nursing
Data sourced from ClinicalTrials.gov (NCT02242760). 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.