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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

MVOR-1 Trial Summary

This trial will compare the efficacy of DFD-29 to doxycycline and placebo in subjects with moderate to severe papulopustular rosacea.

Eligible Conditions
  • Papulopustular Rosacea

MVOR-1 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Investigator's Global Assessment (IGA) Treatment Success Compared to Placebo.
Total Inflammatory Lesion Count Reduction Compared to Placebo.
Secondary outcome measures
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

Side effects data

From 2018 Phase 4 trial • 273 Patients • NCT03075891
4%
Nasopharyngitis
2%
Headache
1%
Spinal pain
1%
Upper respiratory tract infection
1%
Rhinorrhoea
1%
Rosacea
1%
Multilevel discopathy in the cervical spine
1%
Diarrhoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules
Ivermectin 1% Cream + Oral Placebo Capsules

MVOR-1 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
234 Previous Clinical Trials
22,906 Total Patients Enrolled
Srinivas R Sidgiddi, M.D.Study DirectorJourney Medical Corporation
2 Previous Clinical Trials
354 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many hospitals are included in this clinical trial?

"28 patients have already enrolled at locations like Derm Dox Center for Dermatology in Sugarloaf, Clinical Trial Site 05 in Rogers, and Clinical Trial Site 10 in Cerritos, with 28 other enrollees at other locations."

Answered by AI

Are people with the specified medical condition able to enroll in the trial at this time?

"The trial you are inquiring about is still recruiting patients, as of today. The original posting date for this clinical trial was March 14th, 2022 with the most recent edit occurring on May 8th, 2022."

Answered by AI

What are the most common adverse effects of DFD-29?

"DFD-29 is considered safe according to our team's 3-point scale. This is because DFD-29 is in Phase 3 of clinical trials, meaning that there is not only some data supporting its efficacy, but also multiple rounds of data supporting its safety."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Tennessee
How old are they?
18 - 65
What site did they apply to?
Clinical Trial Site 23
Clinical Trial Site 07
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I have rosacea and would like treatment.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Randomized, Double-Blind Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea.
2022. "A Randomized, Double-Blind Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05296629.
~105 spots leftby Apr 2025
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