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A Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea (MVOR-2) (MVOR-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05343455
Recruitment Status : Completed
First Posted : April 25, 2022
Last Update Posted : August 2, 2023
Sponsor:
Collaborator:
Dr. Reddy's Laboratories Limited
Information provided by (Responsible Party):
Journey Medical Corporation

Tracking Information
First Submitted Date  ICMJE April 18, 2022
First Posted Date  ICMJE April 25, 2022
Last Update Posted Date August 2, 2023
Actual Study Start Date  ICMJE March 29, 2022
Actual Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2022)
  • 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. The IGA is a 5-point scale ranging from '0'-Clear to '4' Severe, in which lower scores indicate a better outcome.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 18, 2022)
  • 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.
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2022)
  • 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.
  • 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. The IGA is a 5-point scale ranging from '0'-Clear to '4' Severe, in which lower scores indicate a better outcome.
  • 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.
  • Clinician's Erythema Assessment (CEA) Change 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. The CEA is a 5-point scale ranging from '0' - No Redness to '4' - Fiery Redness, in which lower scores indicate a better outcome.
  • 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. The DLQI is a questionnaire with 10 questions. Each question is scored from 0 to 3. The total score can range from 0 to 30, where 0 means no impact of the disease on quality of life and 30 means maximum impact. Lower scores indicate better outcomes.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2022)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea (MVOR-2)
Official Title  ICMJE 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
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. Of the 320 subjects, approximately 160 subjects are planned to be enrolled at 15 sites in the US, while the remaining subjects are to be enrolled at 14 sites in the EU.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
A multinational, multicenter, randomized, parallel-group, double-blind, controlled study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Papulopustular Rosacea
Intervention  ICMJE
  • Drug: DFD-29
    DFD-29 (40 mg) extended release capsules
  • Drug: Doxycycline
    Doxycycline 40 mg capsules
  • Drug: Placebo
    Placebo capsules
Study Arms  ICMJE
  • Experimental: DFD-29
    DFD-29 (40 mg) extended release capsules
    Intervention: Drug: DFD-29
  • Active Comparator: Doxycycline 40 mg
    Doxycycline 40 mg modified release capsules
    Intervention: Drug: Doxycycline
  • Placebo Comparator: Placebo
    Placebo capsules matching DFD-29
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 16, 2023)		 330
Original Estimated Enrollment  ICMJE
 (submitted: April 18, 2022)		 320
Actual Study Completion Date  ICMJE June 30, 2023
Actual Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05343455
Other Study ID Numbers  ICMJE DFD-29-CD-005
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Journey Medical Corporation
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Journey Medical Corporation
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Dr. Reddy's Laboratories Limited
Investigators  ICMJE
Study Director: Srinivas R Sidgiddi, M.D. Journey Medical Corporation
PRS Account Journey Medical Corporation
Verification Date August 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP