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

Sponsor
Journey Medical Corporation (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05296629
Collaborator
Dr. Reddy's Laboratories Limited (Industry)
320
Enrollment
27
Locations
3
Arms
9.6
Anticipated Duration (Months)
11.9
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
320 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A multicenter, randomized, parallel-group, double-blind, controlled study.A multicenter, randomized, parallel-group, double-blind, controlled study.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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.
Actual Study Start Date :
Mar 14, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Investigator's Global Assessment (IGA) Treatment Success Compared to Placebo. [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.

  2. Total Inflammatory Lesion Count Reduction Compared to Placebo. [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.

Secondary Outcome Measures

  1. Percentage Change in Total Inflammatory Lesion Count Compared to Placebo. [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.

  2. IGA Treatment Success Compared to Doxycycline. [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.

  3. Total Inflammatory Lesion Count Reduction Compared to Doxycycline. [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.

  4. Clinician's Erythema Assessment (CEA) Compared to Placebo. [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.

  5. Change in Dermatology Life Quality Index (DLQI) Score Compared to Placebo. [Baseline to Week 16.]

    Change in DLQI score from Baseline to Week 16 in the DFD-29 group compared to Placebo.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • Journey Medical Corporation
  • Dr. Reddy's Laboratories Limited

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Journey Medical Corporation
ClinicalTrials.gov Identifier:
NCT05296629
Other Study ID Numbers:
  • DFD-29-CD-004
First Posted:
Mar 25, 2022
Last Update Posted:
May 10, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Rosacea
Doxycycline

Study Results

No Results Posted as of May 10, 2022