This study is designed to evaluate the efficacy and safety of Prurisol using three different oral daily dose regimens administered to subjects with active mild to moderate chronic plaque psoriasis.
The total duration of study participation for an individual subject is approximately 112 days (16 weeks) consisting of a Screening visit, followed within 21 days by Randomization and a Treatment Period of 84 days, and a Follow-up Period of 28 days after the last day of study drug treatment. A window of ± 3 days will be considered acceptable for conduct of each scheduled visit following the first visit. This study will require eight (8) scheduled subject visits: x Visit 1: Screening (Up to Day 21) x Visit 2: Baseline (Day 0) x Visit 3: Day 14 Interim (± 3 days) x Visit 4: Day 28 Interim (± 3 days) x Visit 5: Day 42 Interim (± 3 days) x Visit 6: Day 56 Interim (± 3 days) x Visit 7: Day 84 End of Treatment/Unscheduled/ET (± 3 days) x Visit 8: Day 112 Follow-up (± 3 days)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
115
Cellceutix Study Center
Huntsville, Alabama, United States
Cellceutix Study Center
Encino, California, United States
Cellceutix Study Center
Coral Gables, Florida, United States
Cellceutix Study Center
Hialeah, Florida, United States
The primary efficacy endpoint will be the percentage of subjects with ≥ 2 point improvement in IGA rating as defined by visual inspections of patient lesions
Time frame: 84 days
The Secondary efficacy endpoints are the percentage of subjects in each treatment group with:≥ 2 point improvement in IGA at 28 days
Time frame: 28 days
The Secondary efficacy endpoints are the percentage of subjects in each treatment group with: ≥ 2 point improvement in IGA at 56 days
Time frame: 56 Days
The Secondary efficacy endpoints are the percentage of subjects in each treatment group with: ≥1 point improvement in Scaling Score of Target Lesion at 28 days
Time frame: 28 Days
The Secondary efficacy endpoints are the percentage of subjects in each treatment group with: ≥1 point improvement in Scaling Score of Target Lesion at 56 days
Time frame: 56 Days
The Secondary efficacy endpoints are the percentage of subjects in each treatment group with: ≥1 point improvement in Scaling Score of Target Lesion at 84 days
Time frame: 84 Days
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Cellceutix Study Center
Kissimmee, Florida, United States
Cellceutix Study Center
Miami, Florida, United States
Cellceutix Study Center
Miami, Florida, United States
Cellceutix Study Center
Pembroke Pines, Florida, United States
Cellceutix Study Center
Las Vegas, Nevada, United States