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NCT02798120 · ClinicalTrials.gov registry record · Phase 3
P3 Long Term Safety Study of Once Daily SB204 in Acne
A Phase 3 study of Acne Vulgaris, sponsored by Novan.
- Completed
- Registry status
- Phase 3
- Development phase
- 601
- Enrollment target
- 20
- Study locations
NCT02798120: Completed Phase 3 study of Acne Vulgaris, sponsored by Novan.
NCT02798120 is a Phase 3 study of Acne Vulgaris that has completed, run by Novan. The registered enrollment target is 601 participants, above the 266-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (126% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02798120, a Phase 3 study of Acne Vulgaris, has completed, sponsored by Novan.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 601 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multi-center, open label long-term safety (LTS) study to be conducted in approximately 600 subjects with acne vulgaris.
Primary Outcome
This outcome measure shows the number of subjects with at least one ongoing adverse event from the pivotal studies (NI-AC301 and NI-AC302) at the time they rolled over into this study (NI-AC303). The final study visit (Week 12) for the pivotal studies served as the Baseline visit for this study. Subjects who were assigned to SB204 in the pivotal studies are denoted as SB204 Experienced and subjects who were assigned to Vehicle Gel on the pivotal studies are denoted as SB204 Naive.
Conditions Studied
Interventions
- DRUG SB204 4%
Study Locations (20)
California
- CIL #146 - Anaheim
- CIL #139 - Cerritos
- CIL #216 - Chula Vista
- CIL #186 - Fresno
- CIL #210 - Fresno
- CIL #174 - Huntington Beach
- CIL #213 - La Mesa
- CIL #209 - Oceanside
- CIL #190 - Sacramento
- CIL #161 - San Diego
- CIL #113 - San Diego
- CIL #195 - Santa Ana
- CIL #119 - Santa Monica
- CIL #199 - Santa Rosa
Florida
- CIL #103 - Boca Raton
- CIL #208 - Hialeah
- CIL #212 - Homestead
Alabama
- CIL #138 - Birmingham
- CIL #218 - Mobile
Arizona
- CIL #189 - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 601 participants |
| Start Date | 2016-05-12 |
| Est. Completion | 2017-04-27 |
| Phase | Phase 3 |
What the finished NCT02798120 record still lists
NCT02798120 is an interventional study that assigns participants to a tested intervention. The registered 601 participants enrollment target is mid-sized for trials with a published cap, above the 266-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (126% higher).
The record links to 1 condition, with Acne Vulgaris appearing as the primary indexed condition, and to 1 intervention - of which SB204 4% is the first listed.
NCT02798120 names 20 study sites across 4 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT02798120 about?
NCT02798120 is a clinical study titled "P3 Long Term Safety Study of Once Daily SB204 in Acne". This is a multi-center, open label long-term safety (LTS) study to be conducted in approximately 600 subjects with acne vulgaris.
What is the current status of trial NCT02798120?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 601 participants. The study started on 2016-05-12. Estimated completion is 2017-04-27.
What conditions does trial NCT02798120 study?
This clinical trial studies the following conditions: Acne Vulgaris.
What interventions are being tested in trial NCT02798120?
The interventions under investigation include: SB204 4% (DRUG).
Who is sponsoring clinical trial NCT02798120?
This trial is sponsored by Novan, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02798120 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02798120's enrollment target sits among peer trials
601 13th of 67 higher than 55 of 67 other Acne Vulgaris trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acne Vulgaris trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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