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NCT05296629 · ClinicalTrials.gov registry record · Phase 3
A Randomized, Double-Blind Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea.
A Phase 3 study of Papulopustular Rosacea, sponsored by Journey Medical Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 323
- Enrollment target
- 20
- Study locations
NCT05296629: Completed Phase 3 study of Papulopustular Rosacea, sponsored by Journey Medical Corporation.
NCT05296629 is a Phase 3 study of Papulopustular Rosacea that has completed, run by Journey Medical Corporation. The registered enrollment target is 323 participants, above the 250-participant average among 11 other Papulopustular Rosacea trials with a reported enrollment target (29% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05296629, a Phase 3 study of Papulopustular Rosacea, has completed, sponsored by Journey Medical Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 323 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.
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)
California
- Clinical Trial Site 10 - Cerritos
- Clinical Trial Site 03 - Fremont
- Clinical Trial Site 25 - San Diego
- Clinical Trial Site 29 - San Diego
Florida
- Clinical Trial Site 11 - Clearwater
- Clinical Trial Site 08 - Coral Gables
- Clinical Trial Site 22 - Coral Gables
Michigan
- Clinical Trial Site 18 - Ann Arbor
- Clinical Trial Site 28 - Warren
North Carolina
- Clinical Trial Site 17 - High Point
- Clinical Trial Site 04 - Wilmington
Arkansas
- Clinical Trial Site 05 - Rogers
Indiana
- Clinical Trial Site 02 - Indianapolis
Kansas
- Clinical Trial Site 27 - Overland Park
Massachusetts
- Clinical Trial Site 09 - Brighton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 323 participants |
| Start Date | 2022-03-14 |
| Est. Completion | 2023-06-30 |
| Phase | Phase 3 |
What the finished NCT05296629 record still lists
NCT05296629 is an interventional study that assigns participants to a tested intervention. The registered 323 participants enrollment target is mid-sized for trials with a published cap, above the 250-participant average among 11 other Papulopustular Rosacea trials with a reported enrollment target (29% 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.
NCT05296629 names 20 study sites across 13 states, led by California, Florida, Michigan.
Frequently Asked Questions
What is clinical trial NCT05296629 about?
NCT05296629 is a clinical study titled "A Randomized, Double-Blind Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea.". 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 NCT05296629?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 323 participants. The study started on 2022-03-14. Estimated completion is 2023-06-30.
What conditions does trial NCT05296629 study?
This clinical trial studies the following conditions: Papulopustular Rosacea.
What interventions are being tested in trial NCT05296629?
The interventions under investigation include: Placebo (DRUG), Doxycycline (DRUG), DFD-29 (DRUG).
Who is sponsoring clinical trial NCT05296629?
This trial is sponsored by Journey Medical Corporation, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05296629 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Indiana, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05296629's enrollment target sits among peer trials
323 4th of 11 higher than 8 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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