A Study to Evaluate Safety and Equivalence of Generic Azelaic Acid Foam and Finacea® Foam in Participants With Rosacea
Public ClinicalTrials.gov record NCT03287791. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Double-Blind, Randomized, Parallel-Group, Vehicle-Controlled Study to Evaluate Safety and Clinical Equivalence of a Generic Azelaic Acid Foam, 15% and the Reference Listed Finacea® (Azelaic Acid) Foam,15% in Patients With Moderate Facial Rosacea
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03287791
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 924 participants
Conditions and interventions
Conditions
Interventions
- Generic Azelaic Acid Foam Drug
- Finacea® (Azelaic Acid) Foam Drug
- Vehicle Foam Drug
- Cleanser Other
- Sunscreen Other
- Towel Other
- Moisturizing Lotion Other
Drug · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 19, 2016 (Actual)
- Primary completion
- Jun 22, 2017 (Actual)
- Completion
- Jun 22, 2017 (Actual)
- Last update posted
- Jul 31, 2019
2016 – 2017
United States locations
- U.S. sites
- 26
- U.S. states
- 13
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigative Site 2 | Encino | California | — | — |
| Investigative Site 10 | La Mesa | California | — | — |
| Investigative Site 19 | Brandon | Florida | — | — |
| Investigative Site 1 | Hialeah | Florida | — | — |
| Investigative Site 9 | Hialeah | Florida | — | — |
| Investigative Site 23 | Lauderdale Lakes | Florida | — | — |
| Investigative Site 11 | Miami | Florida | — | — |
| Investigative Site 15 | Miami | Florida | — | — |
| Investigative Site 20 | Miami | Florida | — | — |
| Investigative Site 12 | Miramar | Florida | — | — |
| Investigative Site 25 | Ocala | Florida | — | — |
| Investigative Site 22 | Pembroke Pines | Florida | — | — |
| Investigative Site 18 | Tampa | Florida | — | — |
| Investigative Site 16 | Savannah | Georgia | — | — |
| Investigative Site 14 | Plainfield | Indiana | — | — |
| Investigative Site 13 | Wichita | Kansas | — | — |
| Investigative Site 6 | New Orleans | Louisiana | — | — |
| Investigative Site 17 | Omaha | Nebraska | — | — |
| Investigative Site 8 | High Point | North Carolina | — | — |
| Investigative Site 3 | Cincinnati | Ohio | — | — |
| Investigative Site 21 | Philadelphia | Pennsylvania | — | — |
| Investigative Site 4 | Dallas | Texas | — | — |
| Investigative Site 26 | El Paso | Texas | — | — |
| Investigative Site 7 | New Braunfels | Texas | — | — |
| Investigative Site 5 | Norfolk | Virginia | — | — |
| Investigative Site 24 | Spokane | Washington | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03287791, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 31, 2019 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03287791 live on ClinicalTrials.gov.