This is a double-blind, multicenter, vehicle-controlled, parallel group comparison study to determine and compare the efficacy and safety of HBP Lotion 0.05% and Vehicle Lotion applied twice daily for two weeks in subjects with moderate to severe plaque psoriasis. Eligible subjects will be randomized (1:1) to one of two treatment groups - HBP Lotion 0.05% or Vehicle Lotion. The maximum amount of test article to be applied per week should not exceed 50 grams.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
Apply twice daily for 1-2 weeks, not to exceed 50 grams per week
Therapeutics Clinical Research
San Diego, California, United States
Minnesota Clinical Study Center
Fridley, Minnesota, United States
DermResearch, Inc.
Austin, Texas, United States
Overall Disease Severity Score (Success)
Overall disease severity (ODS) will be recorded at baseline, Day 8, and Day 15 on a 0 (clear) to 4 (severe/very severe) point scale. The primary efficacy endpoint was the percentage of subjects with ODS treatment "success" at end of treatment (Day 15). Success was defined as a grade of 0 or 1 on the ODS scale.
Time frame: Day 15
Percent Body Surface Area
Changes in percent BSA with active psoriasis in the Treatment Area
Time frame: Baseline, Days 8 and 15
Clinical Signs and Symptoms of Psoriasis
The proportion of subjects rated a "treatment success" for each of the clinical signs and symptoms of psoriasis: scaling, erythema, plaque elevation and pruritis. "Treatment success" is defined as a score of 0 or 1 on a five-point scale ranging from 0 = clear to 4 = severe/very severe.
Time frame: Days 8 and 15
Overall Disease Severity Score (Improvement)
The proportion of subjects rated a "improved" for ODS at Day 8 and Day 15. "Improvement" is defined as at least a two (2) grade decrease in severity score relative to baseline using a five-point scale ranging from 0 = clear to 4 = severe/very severe.
Time frame: Days 8 and 15
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.