A Randomized, Double-Blind Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea. (MVOR-1)

August 1, 2023 updated by: Journey Medical Corporation

A Multicenter, Randomized, Double-Blind, Parallel-Group, Active and Placebo Controlled Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Extended Release Capsules for the Treatment of Inflammatory Lesions of Rosacea Over 16 Weeks.

This is a 16-week, multicenter, randomized, parallel-group, double-blind, controlled study. After assessing eligibility during a screening period of up to 30 days, approximately 320 subjects at least 18 years old who are diagnosed with moderate to severe papulopustular rosacea will be randomized in a 3:3:2 ratio to DFD-29 (40 mg), Doxycycline capsules 40 mg, or Placebo once daily for 16 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a 16-week, multicenter, randomized, parallel-group, double-blind, controlled study. After assessing eligibility during a screening period of up to 30 days, approximately 320 subjects at least 18 years old who are diagnosed with moderate to severe papulopustular rosacea will be randomized in a 3:3:2 ratio to DFD-29 (40 mg), Doxycycline capsules 40 mg, or Placebo once daily for 16 weeks.

Subject visits are scheduled at Screening, Baseline (Day 1), and Weeks 2, 4, 8, 12, and 16. Clinical assessments of efficacy will be conducted based on Investigator's Global Assessment modified scale without erythema (IGA), Clinician's Erythema Assessment (CEA), and total inflammatory lesion count at Weeks 2, 4, 8, 12, and 16 compared to Baseline.

Laboratory assessments of blood (hematology and biochemistry) and urine (routine tests) will be conducted at Screening and Week 16 (end of study [EOS] or early termination) to assess for any changes in the safety parameters. Other safety assessments include vital signs, physical examination, urine pregnancy tests (for females of childbearing potential), and collection of AE data.

The impact of the treatment on the quality of life (QoL) of the subjects will be assessed using the rosacea-specific tool RosaQoL in addition to the Dermatology Life Quality Index (DLQI) at Baseline and Weeks 2, 4, 8, 12, and 16.

Study Type

Interventional

Enrollment (Actual)

323

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Rogers, Arkansas, United States, 72758
        • Clinical Trial Site 05
    • California
      • Cerritos, California, United States, 90703
        • Clinical Trial Site 10
      • Fremont, California, United States, 94538
        • Clinical Trial Site 03
      • San Diego, California, United States, 92123
        • Clinical Trial Site 25
      • San Diego, California, United States, 92123
        • Clinical Trial Site 29
    • Florida
      • Clearwater, Florida, United States, 33761
        • Clinical Trial Site 11
      • Coral Gables, Florida, United States, 33134
        • Clinical Trial Site 08
      • Coral Gables, Florida, United States, 33134
        • Clinical Trial Site 22
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Clinical Trial Site 02
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Clinical Trial Site 27
    • Massachusetts
      • Brighton, Massachusetts, United States, 02135
        • Clinical Trial Site 09
    • Michigan
      • Ann Arbor, Michigan, United States, 48103
        • Clinical Trial Site 18
      • Warren, Michigan, United States, 48088
        • Clinical Trial Site 28
    • Minnesota
      • New Brighton, Minnesota, United States, 55112
        • Clinical Trial Site 21
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Clinical Trial Site 15
    • New York
      • New York, New York, United States, 10019
        • Clinical Trial Site 24
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Clinical Trial Site 17
      • Wilmington, North Carolina, United States, 28405
        • Clinical Trial Site 04
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Clinical Trial Site 06
    • Pennsylvania
      • Sugarloaf, Pennsylvania, United States, 18249
        • Clinical Trial Site 01
    • Rhode Island
      • East Greenwich, Rhode Island, United States, 02818
        • Clinical Trial Site 19
    • Tennessee
      • Nashville, Tennessee, United States, 37215
        • Clinical Trial Site 23
    • Texas
      • College Station, Texas, United States, 77845
        • Clinical Trial Site 20
      • Houston, Texas, United States, 77055
        • Clinical Trial Site 13
      • Plano, Texas, United States, 75093
        • Clinical Trial Site 07
      • San Antonio, Texas, United States, 78213
        • Clinical Trial Site 26
      • San Antonio, Texas, United States, 78229
        • Clinical Trial Site 12

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Male and female subjects aged 18 years and above.
  • Subjects must be in good general health as determined by the investigator and supported by the medical history.
  • Subjects must have a clinical diagnosis of papulopustular rosacea with IGA grade 3 (moderate) or IGA grade 4 (severe) at Baseline.
  • Subjects must have 15 to 60 (both inclusive) inflammatory lesions (papules and pustules) of rosacea over the face at Baseline.
  • Subjects must have not more than 2 nodules or cysts at Baseline.

Key Exclusion Criteria:

  • Female subjects who are pregnant or nursing or planning to become pregnant during the study.
  • Male subjects whose female partner is planning to conceive a child.
  • Clinically significant abnormal laboratory test results that, in the opinion of the investigator, would compromise the subject's safety or ability to participate in the trial.
  • History of organ transplant requiring immunosuppression, HIV, or other immune compromised state.
  • History of lupus-like syndrome, autoimmune hepatitis, vasculitis, or serum sickness.
  • Any clinically significant condition or situation other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DFD-29
DFD-29 (40 mg) extended release capsules
Drug: DFD-29
DFD-29 (40 mg) extended release capsules
Active Comparator: Doxycycline 40 mg
Doxycycline 40 mg modified release capsules
Drug: Doxycycline
Doxycycline 40 mg capsules
Placebo Comparator: Placebo
Placebo capsules matching DFD-29
Drug: Placebo
Placebo capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Inflammatory Lesion Count Reduction Compared to Placebo.
Time Frame: Baseline to Week 16.
Total inflammatory lesion count (sum of papules, pustules, and nodules) reduction from Baseline to Week 16, in the DFD-29 group compared to Placebo.
Baseline to Week 16.
Investigator's Global Assessment (IGA) Treatment Success Compared to Placebo.
Time Frame: Baseline to Week 16.
Proportion of subjects with IGA (modified scale without erythema) 'treatment success' - Grade 0 or 1 at Week 16 with at least 2 grade reduction from Baseline to Week 16, in the DFD-29 group compared to Placebo.
Baseline to Week 16.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage Change in Total Inflammatory Lesion Count Compared to Placebo.
Time Frame: Baseline to Week 16.
Percentage Change in Total inflammatory lesion count (sum of papules, pustules, and nodules) from Baseline to Week 16, in the DFD-29 group compared to Placebo.
Baseline to Week 16.
Total Inflammatory Lesion Count Reduction Compared to Doxycycline.
Time Frame: Baseline to Week 16.
Total inflammatory lesion count reduction from Baseline to week 16 in the DFD-29 group compared to Doxycycline capsules 40 mg.
Baseline to Week 16.
IGA Treatment Success Compared to Doxycycline.
Time Frame: Baseline to Week 16.
Proportion of subjects with IGA treatment success at week 16 in the DFD-29 group compared to Doxycycline capsules 40 mg.
Baseline to Week 16.
Clinician's Erythema Assessment (CEA) Compared to Placebo.
Time Frame: Baseline to Week 16.
Proportion of subjects with at least 2-grade reduction in CEA score from Baseline to Week 16 in the DFD-29 group compared to Placebo.
Baseline to Week 16.
Change in Dermatology Life Quality Index (DLQI) Score Compared to Placebo.
Time Frame: Baseline to Week 16.
Change in DLQI score from Baseline to Week 16 in the DFD-29 group compared to Placebo.
Baseline to Week 16.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Journey Medical Corporation

Collaborators

Dr. Reddy's Laboratories Limited

Investigators

  • Study Director: Srinivas R Sidgiddi, M.D., Journey Medical Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2022

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

March 17, 2022

First Submitted That Met QC Criteria

March 17, 2022

First Posted (Actual)

March 25, 2022

Study Record Updates

Last Update Posted (Actual)

August 2, 2023

Last Update Submitted That Met QC Criteria

August 1, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DFD-29-CD-004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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