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COMPLETED Phase 3

A Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea (MVOR-2)

NCT05343455 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 330 participants
Start Date 2022-03-29
Est. Completion 2023-06-30
Phase Phase 3

Sponsor

Journey Medical Corporation

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05343455

The ClinicalTrials.gov registry entry for NCT05343455 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 330 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Journey Medical Corporation, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05343455 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Other, Florida, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05343455?

The interventions under investigation include: Placebo (DRUG), Doxycycline (DRUG), DFD-29 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05343455?

This trial is sponsored by Journey Medical Corporation, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial