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NCT02682264 · ClinicalTrials.gov registry record · Phase 3
An Open-Label, Long-Term Extension Study to Evaluate the Safety of CB-03-01 Cream, 1% in Participants With Acne Vulgaris
A Phase 3 study of Acne Vulgaris, sponsored by Cassiopea SpA.
- Completed
- Registry status
- Phase 3
- Development phase
- 609
- Enrollment target
- 20
- Study locations
NCT02682264: Completed Phase 3 study of Acne Vulgaris, sponsored by Cassiopea SpA.
NCT02682264 is a Phase 3 study of Acne Vulgaris that has completed, run by Cassiopea SpA. The registered enrollment target is 609 participants, above the 266-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (129% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02682264, a Phase 3 study of Acne Vulgaris, has completed, sponsored by Cassiopea SpA.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 609 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of this study is to determine the long-term safety of CB-03-01 cream, 1% applied twice daily for an additional nine months in study participants with acne vulgaris that participated in the Phase 3 pivotal studies for a total treatment of up to 12 months.
Primary Outcome
Number of participants with any local and systemic treatment emergent AEs (TEAEs)
Conditions Studied
Interventions
- DRUG CB-03-01 cream, 1%
Study Locations (20)
California
- Center for Dermatology and Laser Surgery - Sacramento
- Rady Childrens Hospital, Pediatric and Adolescent Dermatology - San Diego
- Southern California Dermatology - Santa Ana
- Clinical Science Institute - Santa Monica
- Memorial Research Medical Clinic dba / Orange County Research Center - Tustin
Florida
- Study Protocol, Inc. - Boynton Beach
- Tory Sullivan, M.D., P.A. - North Miami Beach
- Belleair Research Center - Pinellas Park
- Meridien Research - St. Petersburg
- MOORE Clinical Research, Inc. - Tampa
Arkansas
- Johnson Dermatology - Fort Smith
- Gary M. Petrus, MD PA - Little Rock
Indiana
- Shideler Clinical Research Center - Carmel
- The Indiana Clinical Trials Center - Plainfield
Colorado
- Horizons Clinical Research Center, LLC - Denver
Georgia
- MedaPhase, Inc. - Newnan
Illinois
- Arlington Dermatology - Arlington Heights
Kansas
- Kansas City Dermatology, PA - Overland Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 609 participants |
| Start Date | 2016-03-09 |
| Est. Completion | 2018-08-31 |
| Phase | Phase 3 |
What the finished NCT02682264 record still lists
NCT02682264 is an interventional study that assigns participants to a tested intervention. The registered 609 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 (129% higher).
The record links to 1 condition, with Acne Vulgaris appearing as the primary indexed condition, and to 1 intervention - of which CB-03-01 cream, 1% is the first listed.
NCT02682264 names 20 study sites across 10 states, led by California, Florida, Arkansas.
Frequently Asked Questions
What is clinical trial NCT02682264 about?
NCT02682264 is a clinical study titled "An Open-Label, Long-Term Extension Study to Evaluate the Safety of CB-03-01 Cream, 1% in Participants With Acne Vulgaris". The primary objective of this study is to determine the long-term safety of CB-03-01 cream, 1% applied twice daily for an additional nine months in study participants with acne vulgaris that participated in the Phase 3 pivotal studies for a total treatment of up to 12 months.
What is the current status of trial NCT02682264?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 609 participants. The study started on 2016-03-09. Estimated completion is 2018-08-31.
What conditions does trial NCT02682264 study?
This clinical trial studies the following conditions: Acne Vulgaris.
What interventions are being tested in trial NCT02682264?
The interventions under investigation include: CB-03-01 cream, 1% (DRUG).
Who is sponsoring clinical trial NCT02682264?
This trial is sponsored by Cassiopea SpA, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02682264 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02682264's enrollment target sits among peer trials
609 12th of 67 higher than 56 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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