Phase 3
N=601
P3 Long Term Safety Study of Once Daily SB204 in Acne
Acne Vulgaris
Bottom Line
View on ClinicalTrials.gov: NCT02798120 ↗Enrolled (actual)
601
Serious AEs
1.0%
Results posted
May 2023
Primary outcome: Primary: Number of Subjects With Adverse Events Ongoing From Parent Study at Start of Study NI-AC303) — 59; 62 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- SB204 4% (Drug)
- Age
- Pediatric, Adult, Older Adult · 9+ yrs
- Sex
- All
- Sponsor
- Novan, Inc.
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Adverse Events Ongoing From Parent Study at Start of Study NI-AC303) |
59; 62 | — |
| PRIMARY Number of Subjects With Treatment Emergent Adverse Events |
54; 58 | — |
| SECONDARY Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment) |
493; 80; 16; 0; 461; 109 | — |
| SECONDARY Inflammatory Lesion Counts by Study Visit |
13.2; 15.3; 12.2; 14.3; 10.8; 13.1 | — |
| SECONDARY Non-Inflammatory Lesion Counts by Study Visit |
23.6; 25.5; 21.9; 23.0; 19.7; 21.5 | — |
Summary
This is a multi-center, open label long-term safety (LTS) study to be conducted in approximately 600 subjects with acne vulgaris.
Eligibility Criteria
Inclusion Criteria
- Have completed 12 weeks of treatment in NI-AC301 or NI-AC302
Exclusion Criteria
- Terminated early from an SB204 Phase 3 pivotal study for any reason
- Have an on-going adverse event at Week 12 visit for NI-AC301 or NI-AC302 that warrants stopping study drug application
- Have used medications or vitamins during the 12 weeks immediately preceding this study which were reported to exacerbate acne.
Data sourced from ClinicalTrials.gov (NCT02798120). 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.