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NCT05343455 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea (MVOR-2)
A Phase 3 study of Papulopustular Rosacea, sponsored by Journey Medical Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 330
- Enrollment target
- 20
- Study locations
NCT05343455: Completed Phase 3 study of Papulopustular Rosacea, sponsored by Journey Medical Corporation.
NCT05343455 is a Phase 3 study of Papulopustular Rosacea that has completed, run by Journey Medical Corporation. The registered enrollment target is 330 participants, above the 249-participant average among 11 other Papulopustular Rosacea trials with a reported enrollment target (33% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05343455, a Phase 3 study of Papulopustular Rosacea, has completed, sponsored by Journey Medical Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 330 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Proportion of subjects with IGA (modified scale without erythema) 'treatment success' - Grade 0 or 1 at Week 16 with at least 2 grade reduction from Baseline to Week 16, in the DFD-29 group compared to Placebo. The modified IGA scale is a 5-point scale from Grade 0 to Grade 4, wherein Grade 0 is Clear, Grade 1 is Near Clear, Grade 2 is Mild, Grade 3 is Moderate and Grade 4 is Severe Rosacea. A lowering of the score with treatment indicates an improvement in the disease condition and a beneficia
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Doxycycline
- DRUG DFD-29
Study Locations (20)
Other
- Clinical Trial Site 17 - Bad Bentheim
- Clinical Trial Site 24 - Berlin
- Clinical Trial Site 22 - Bochum
- Clinical Trial Site 20 - Darmstadt
- Clinical Trial Site 25 - Dülmen
Florida
- Clinical Trial Site 01 - Doral
- Clinical Trial Site 02 - Miami
- Clinical Trial Site 14 - Miami
- Clinical Trial Site 05 - Miramar
Texas
- Clinical Trial Site 12 - Austin
- Clinical Trial Site 03 - Houston
- Clinical Trial Site 07 - Pflugerville
Indiana
- Clinical Trial Site 08 - Clarksville
- Clinical Trial Site 16 - Plainfield
Ohio
- Clinical Trial Site 09 - Cincinnati
- Clinical Trial Site 04 - Dublin
California
- Clinical Trial Site 15 - Santa Monica
Kentucky
- Clinical Trial Site 10 - Louisville
Missouri
- Clinical Trial Site 11 - Saint Joseph
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 330 participants |
| Start Date | 2022-03-29 |
| Est. Completion | 2023-06-30 |
| Phase | Phase 3 |
What the finished NCT05343455 record still lists
NCT05343455 is an interventional study that assigns participants to a tested intervention. The registered 330 participants enrollment target is mid-sized for trials with a published cap, above the 249-participant average among 11 other Papulopustular Rosacea trials with a reported enrollment target (33% higher).
The record links to 1 condition, with Papulopustular Rosacea appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT05343455 names 20 study sites across 9 states, led by Other, Florida, Texas.
Frequently Asked Questions
What is clinical trial NCT05343455 about?
NCT05343455 is a clinical study titled "A Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea (MVOR-2)". 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 ...
What is the current status of trial NCT05343455?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 330 participants. The study started on 2022-03-29. Estimated completion is 2023-06-30.
What conditions does trial NCT05343455 study?
This clinical trial studies the following conditions: Papulopustular Rosacea.
What interventions are being tested in trial NCT05343455?
The interventions under investigation include: Placebo (DRUG), Doxycycline (DRUG), DFD-29 (DRUG).
Who is sponsoring clinical trial NCT05343455?
This trial is sponsored by Journey Medical Corporation, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05343455 being conducted?
This trial has 20 study locations across California, Florida, Indiana, Kentucky, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05343455's enrollment target sits among peer trials
330 3rd of 11 higher than 9 of 11 other Papulopustular Rosacea trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Papulopustular Rosacea 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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