Status:
COMPLETED
A Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea (MVOR-2)
Lead Sponsor:
Journey Medical Corporation
Collaborating Sponsors:
Dr. Reddy's Laboratories Limited
Conditions:
Papulopustular Rosacea
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
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 ...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
March 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT05343455
Start Date
March 29 2022
End Date
June 30 2023
Last Update
December 3 2024
Active Locations (24)
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1
Clinical Trial Site 15
Santa Monica, California, United States, 90404
2
Clinical Trial Site 01
Doral, Florida, United States, 33178
3
Clinical Trial Site 02
Miami, Florida, United States, 33173
4
Clinical Trial Site 14
Miami, Florida, United States, 33175