Papulopustular Rosacea Clinical Trial
— MVOR-1Official 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.
Verified date | August 2023 |
Source | Journey Medical Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 323 |
Est. completion date | June 30, 2023 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Clinical Trial Site 18 | Ann Arbor | Michigan |
United States | Clinical Trial Site 06 | Beachwood | Ohio |
United States | Clinical Trial Site 09 | Brighton | Massachusetts |
United States | Clinical Trial Site 10 | Cerritos | California |
United States | Clinical Trial Site 11 | Clearwater | Florida |
United States | Clinical Trial Site 20 | College Station | Texas |
United States | Clinical Trial Site 08 | Coral Gables | Florida |
United States | Clinical Trial Site 22 | Coral Gables | Florida |
United States | Clinical Trial Site 19 | East Greenwich | Rhode Island |
United States | Clinical Trial Site 03 | Fremont | California |
United States | Clinical Trial Site 17 | High Point | North Carolina |
United States | Clinical Trial Site 13 | Houston | Texas |
United States | Clinical Trial Site 02 | Indianapolis | Indiana |
United States | Clinical Trial Site 15 | Las Vegas | Nevada |
United States | Clinical Trial Site 23 | Nashville | Tennessee |
United States | Clinical Trial Site 21 | New Brighton | Minnesota |
United States | Clinical Trial Site 24 | New York | New York |
United States | Clinical Trial Site 27 | Overland Park | Kansas |
United States | Clinical Trial Site 07 | Plano | Texas |
United States | Clinical Trial Site 05 | Rogers | Arkansas |
United States | Clinical Trial Site 12 | San Antonio | Texas |
United States | Clinical Trial Site 26 | San Antonio | Texas |
United States | Clinical Trial Site 25 | San Diego | California |
United States | Clinical Trial Site 29 | San Diego | California |
United States | Clinical Trial Site 01 | Sugarloaf | Pennsylvania |
United States | Clinical Trial Site 28 | Warren | Michigan |
United States | Clinical Trial Site 04 | Wilmington | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Journey Medical Corporation | Dr. Reddy's Laboratories Limited |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Investigator's Global Assessment (IGA) Treatment Success Compared to Placebo. | 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. | |
Primary | Total Inflammatory Lesion Count Reduction Compared to Placebo. | 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. | |
Secondary | Percentage Change in Total Inflammatory Lesion Count Compared to Placebo. | 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. | |
Secondary | IGA Treatment Success Compared to Doxycycline. | 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. | |
Secondary | Total Inflammatory Lesion Count Reduction Compared to Doxycycline. | 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. | |
Secondary | Clinician's Erythema Assessment (CEA) Compared to Placebo. | 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. | |
Secondary | Change in Dermatology Life Quality Index (DLQI) Score Compared to Placebo. | Change in DLQI score from Baseline to Week 16 in the DFD-29 group compared to Placebo. | Baseline to Week 16. |
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