A Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea (MVOR-2)
Completed · Phase 3 · Has a placebo group
Conditions studied: Papulopustular Rosacea
In brief
This is a 16-week, multicenter, randomized, parallel-group, double-blind, controlled study. After assessing eligibility during a screening period of up to 30 days, approximately 320 subjects at least 18 years old who are diagnosed with moderate to severe papulopustular rosacea will be randomized in a 3:3:2 ratio to DFD-29 (40 mg), Doxycycline capsules 40 mg, or Placebo once daily for 16 weeks. Of the 320 subjects, approximately 160 subjects are planned to be enrolled at 15 sites in the US, while the remaining subjects are to be enrolled at 14 sites in the EU.
Key facts
- Study ID
- NCT05343455
- Run by
- Journey Medical Corporation
- People needed
- 330
- Starts
- 2022-03-29
- Expected to finish
- 2023-06-30
- Last updated by the study team
- 2024-12-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Clinical Trial Site 15 — Santa Monica, California, United States
- Clinical Trial Site 01 — Doral, Florida, United States
- Clinical Trial Site 02 — Miami, Florida, United States
- Clinical Trial Site 14 — Miami, Florida, United States
- Clinical Trial Site 05 — Miramar, Florida, United States
- Clinical Trial Site 08 — Clarksville, Indiana, United States
- Clinical Trial Site 16 — Plainfield, Indiana, United States
- Clinical Trial Site 10 — Louisville, Kentucky, United States
- Clinical Trial Site 11 — Saint Joseph, Missouri, United States
- Clinical Trial Site 09 — Cincinnati, Ohio, United States
- Clinical Trial Site 04 — Dublin, Ohio, United States
- Clinical Trial Site 06 — Anderson, South Carolina, United States
- Clinical Trial Site 12 — Austin, Texas, United States
- Clinical Trial Site 03 — Houston, Texas, United States
- Clinical Trial Site 07 — Pflugerville, Texas, United States
- Clinical Trial Site 17 — Bad Bentheim, Germany
- Clinical Trial Site 24 — Berlin, Germany
- Clinical Trial Site 22 — Bochum, Germany
- Clinical Trial Site 20 — Darmstadt, Germany
- Clinical Trial Site 25 — Dülmen, Germany
- Clinical Trial Site 19 — Hamburg, Germany
- Clinical Trial Site 21 — Langenau, Germany
- Clinical Trial Site 23 — Merzig, Germany
- Clinical Trial Site 18 — Wuppertal, Germany
Full record on ClinicalTrials.gov
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