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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 is a Phase 3 study that has completed, run by Actavis. The registered enrollment target is 924 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03287791
The ClinicalTrials.gov registry entry for NCT03287791 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 924 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Actavis, which has 79 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Sunscreen is the first listed.
NCT03287791 reports 0 study locations.
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.
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