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NCT02413346 · ClinicalTrials.gov registry record · Phase 3
A Multi-Center Open-Label Evaluation of the Safety of Sarecycline Tablets in the Treatment of Acne Vulgaris
A Phase 3 study of Acne Vulgaris, sponsored by Almirall, S.A..
- Completed
- Registry status
- Phase 3
- Development phase
- 490
- Enrollment target
- 20
- Study locations
NCT02413346: Completed Phase 3 study of Acne Vulgaris, sponsored by Almirall, S.A..
NCT02413346 is a Phase 3 study of Acne Vulgaris that has completed, run by Almirall, S.A.. The registered enrollment target is 490 participants, above the 268-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (83% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02413346, a Phase 3 study of Acne Vulgaris, has completed, sponsored by Almirall, S.A..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 490 participants
- Enrollment target
- 20
- Study locations
Study Summary
Open-label study will evaluate the safety of an approximate 1.5 mg/kg/day dose of oral sarecycline in the long-term treatment of participants with moderate to severe facial acne vulgaris.
Primary Outcome
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. A TEAE is an AE that occurs after the first dose of study drug.
Conditions Studied
Interventions
- DRUG Sarecycline
Study Locations (20)
Florida
- Actavis Investigational Study Site #226 - Clearwater
- Actavis Investigational Study Site #238 - Jupiter
- Actavis Investigational Study Site #249 - Miami
- Actavis Investigational Study Site #145 - Miami
- Actavis Investigational Study Site #211 - Miramar
- Actavis Investigation Study Site # 140 - North Miami Beach
- Actavis Investigational Study Site #151 - Orange
- Actavis Investigational Study Site #203 - Tampa
California
- Actavis Investigational Study Site #245 - Carlsbad
- Actavis Investigational Study Site #129 - Encino
- Actavis Investigational Study Site #209 - Fremont
- Actavis Investigational Study Site #147 - Sacramento
- Actavis Investigational Study Site #150 - San Diego
- Actavis Investigational Study Site #125 - San Diego
- Actavis Investigational Study Site #204 - San Diego
Colorado
- Actavis Investigational Study Site #222 - Denver
- Actavis Investigational Study Site #148 - Wheat Ridge
Alabama
- Actavis Investigational Study Site #206 - Mobile
Arkansas
- Actavis Investigational Study Site #236 - Hot Springs
Georgia
- Actavis Investigational Study Site #242 - Snellville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 490 participants |
| Start Date | 2015-03-20 |
| Est. Completion | 2016-08-26 |
| Phase | Phase 3 |
What the finished NCT02413346 record still lists
NCT02413346 is an interventional study that assigns participants to a tested intervention. The registered 490 participants enrollment target is mid-sized for trials with a published cap, above the 268-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (83% higher).
The record links to 1 condition, with Acne Vulgaris appearing as the primary indexed condition, and to 1 intervention - of which Sarecycline is the first listed.
NCT02413346 names 20 study sites across 6 states, led by Florida, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT02413346 about?
NCT02413346 is a clinical study titled "A Multi-Center Open-Label Evaluation of the Safety of Sarecycline Tablets in the Treatment of Acne Vulgaris". Open-label study will evaluate the safety of an approximate 1.5 mg/kg/day dose of oral sarecycline in the long-term treatment of participants with moderate to severe facial acne vulgaris.
What is the current status of trial NCT02413346?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 490 participants. The study started on 2015-03-20. Estimated completion is 2016-08-26.
What conditions does trial NCT02413346 study?
This clinical trial studies the following conditions: Acne Vulgaris.
What interventions are being tested in trial NCT02413346?
The interventions under investigation include: Sarecycline (DRUG).
Who is sponsoring clinical trial NCT02413346?
This trial is sponsored by Almirall, S.A., which has 19 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02413346 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02413346's enrollment target sits among peer trials
490 17th of 67 higher than 51 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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