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A Randomized, Double-Blind Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of 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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 16.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 16.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Total Inflammatory Lesion Count Compared to Placebo.
Investigator's Global Assessment (IGA) Treatment Success Compared to Placebo.
Secondary study objectives
Change in Total Inflammatory Lesion Count Compared to Doxycycline.
Clinician's Erythema Assessment (CEA) Compared to Placebo.
IGA Treatment Success Compared to Doxycycline.
Side effects data
From 2023 Phase 3 trial • 323 Patients • NCT052966293%
COVID-19
3%
Nasopharyngitis
2%
Vulvovaginal mycotic infections
2%
Diarrhea
2%
Headache
1%
Dry Skin
1%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
DFD-29
Placebo
Doxycycline 40 mg
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