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DFD-29 for Papulopustular Rosacea (MVOR-1 Trial)

Phase 3
Waitlist Available
Research Sponsored by Journey Medical Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 16.
Awards & highlights
Pivotal Trial

Summary

This trial tests two medications for treating moderate to severe rosacea in adults. The medications work by reducing skin inflammation and bacteria, aiming to find better treatment options for this condition. Topical metronidazole has been well studied as a treatment for rosacea, often used alone or in combination with oral antibiotics.

Eligible Conditions
  • Papulopustular Rosacea

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 16.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 16. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Investigator's Global Assessment (IGA) Treatment Success Compared to Placebo.
Total Inflammatory Lesion Count Reduction Compared to Placebo.
Secondary study objectives
Change in Dermatology Life Quality Index (DLQI) Score Compared to Placebo.
Clinician's Erythema Assessment (CEA) Compared to Placebo.
IGA Treatment Success Compared to Doxycycline.
+2 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: DFD-29Experimental Treatment1 Intervention
DFD-29 (40 mg) extended release capsules
Group II: Doxycycline 40 mgActive Control1 Intervention
Doxycycline 40 mg modified release capsules
Group III: PlaceboPlacebo Group1 Intervention
Placebo capsules matching DFD-29
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DFD-29
2022
Completed Phase 3
~660

Find a Location

Who is running the clinical trial?

Journey Medical CorporationLead Sponsor
9 Previous Clinical Trials
2,050 Total Patients Enrolled
Dr. Reddy's Laboratories LimitedIndustry Sponsor
235 Previous Clinical Trials
47,164 Total Patients Enrolled
Srinivas R Sidgiddi, M.D.Study DirectorJourney Medical Corporation
2 Previous Clinical Trials
354 Total Patients Enrolled
~90 spots leftby Nov 2025
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