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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 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
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 moreSide effects data
From 2018 Phase 4 trial • 273 Patients • NCT030758914%
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
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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
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