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NCT03287791 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Safety and Equivalence of Generic Azelaic Acid Foam and Finacea® Foam in Participants With Rosacea
A Phase 3 study, sponsored by Actavis.
- Completed
- Registry status
- Phase 3
- Development phase
- 924
- Enrollment target
NCT03287791: Completed Phase 3 study, sponsored by Actavis.
NCT03287791 is a Phase 3 study that has completed, run by Actavis. The registered enrollment target is 924 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03287791, a Phase 3 study, has completed, sponsored by Actavis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 924 participants
- Enrollment target
Study Summary
The objectives of this study were to compare the safety and efficacy profiles of a generic Azelaic Acid Foam, 15% to the reference listed Finacea® (azelaic acid) Foam, 15% and to demonstrate therapeutic equivalence and safety of the two active foams in the treatment of moderate facial rosacea, and to demonstrate superiority of the Reference and Test products over the Vehicle.
Primary Outcome
All facial papules, pustules, and nodules, located above the jaw line and extending to the hairline, were counted. When counting facial lesions, lesions present on the nose were included. The total count for each lesion type was recorded and the total number of inflammatory lesions (papules and pustules) were calculated. A papule with a pustule on its apex was counted as a pustule. Counts of nodules and cysts were reported separately and not included in the inflammatory counts. Papule defined as
Interventions
- OTHER Sunscreen
- DRUG Vehicle Foam
- OTHER Cleanser
- DRUG Generic Azelaic Acid Foam
- DRUG Finacea® (Azelaic Acid) Foam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 924 participants |
| Start Date | 2016-07-19 |
| Est. Completion | 2017-06-22 |
| Phase | Phase 3 |
What the finished NCT03287791 record still lists
NCT03287791 is an interventional study that assigns participants to a tested intervention. The registered 924 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (20% higher).
The record links to 0 conditions, and to 5 interventions - of which Sunscreen is the first listed.
NCT03287791 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03287791 about?
NCT03287791 is a clinical study titled "A Study to Evaluate Safety and Equivalence of Generic Azelaic Acid Foam and Finacea® Foam in Participants With Rosacea". The objectives of this study were to compare the safety and efficacy profiles of a generic Azelaic Acid Foam, 15% to the reference listed Finacea® (azelaic acid) Foam, 15% and to demonstrate therapeutic equivalence and safety of the two active foams in the treatment of moderate facial rosacea, and t...
What is the current status of trial NCT03287791?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 924 participants. The study started on 2016-07-19. Estimated completion is 2017-06-22.
What interventions are being tested in trial NCT03287791?
The interventions under investigation include: Sunscreen (OTHER), Vehicle Foam (DRUG), Cleanser (OTHER), Generic Azelaic Acid Foam (DRUG), Finacea® (Azelaic Acid) Foam (DRUG).
Who is sponsoring clinical trial NCT03287791?
This trial is sponsored by Actavis, which has 79 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03287791's enrollment target sits among peer trials
924 342nd of 2000 higher than 1,658 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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