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DFD-29 for Papulopustular Rosacea (MVOR-2 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-2 Trial Summary

This trial will compare the effectiveness of two different medications for treating rosacea, a skin condition that causes redness and bumps.

Eligible Conditions
  • Papulopustular Rosacea

MVOR-2 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) Change Compared to Placebo.
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-2 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
2,043 Total Patients Enrolled
Dr. Reddy's Laboratories LimitedIndustry Sponsor
234 Previous Clinical Trials
22,899 Total Patients Enrolled
Srinivas R Sidgiddi, M.D.Study DirectorJourney Medical Corporation
2 Previous Clinical Trials
347 Total Patients Enrolled

Frequently Asked Questions

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

What is the current FDA status of DFD-29?

"DFD-29 is deemed safe by our team at Power, who gave it a score of 3. This is because DFD-29 is a Phase 3 trial, meaning that there is already some evidence of its efficacy, and that there is also multiple rounds of data supporting its safety."

Answered by AI

Are there several study sites in North America?

"Currently, 16 different medical centres are running this clinical trial including the Clinical Science Institute in Santa Monica, Clinical Trial Site 15 in Doral, and Clinical Trial Site 01 in Miami."

Answered by AI

Are we looking for more test subjects for this experiment?

"The clinical trial is currently recruiting patients, as of the latest update on clinicaltrials.gov from 2022-08-27. This study was initially posted on 2022-03-29 and is looking for 320 participants from 16 different locations."

Answered by AI

What aim does this experiment hope to achieve?

"The primary outcome for this study, which will be measured over a 16-week period, is the Investigator's Global Assessment (IGA) Treatment Success Compared to Placebo. Additionally, this trial will assess secondary outcomes including IGA Treatment Success Compared to Doxycycline, Clinician's Erythema Assessment (CEA) Compared to Placebo, and Change in Dermatology Life Quality Index (DLQI) Score Compared to Placebo."

Answered by AI

Who else is applying?

What state do they live in?
Texas
California
Ohio
How old are they?
18 - 65
What site did they apply to?
Clinical Science Institute
Clinical Trial Site 04
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

~110 spots leftby Apr 2025