Corticosteroids are one of the mainstays of treatment for subjects with corticosteroid-responsive dermatoses such as psoriasis. This study has been designed to determine and compare the efficacy and safety of a formulation of 122-0551 versus the corresponding Vehicle in subjects with stable plaque psoriasis after twice daily dosing for 14 consecutive days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
44
Therapeutics Clinical Research
San Diego, California, United States
DermResearch, Inc.
Austin, Texas, United States
Change in Overall Disease Severity (ODS) Score
The percentage of subjects with ODS "treatment success" at EOS where EOS is the subject's last completed visit. "Treatment success" is defined as an ODS of 0 or 1. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe.
Time frame: baseline and Day 15 (End of Study - EOS)
ODS "Treatment Success" at Day 8 and Day 15
The percentage of subjects with ODS "treatment success" at Day 8 and Day 15. "Treatment success" is defined as an ODS of 0 or 1. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe.
Time frame: baseline, Day 8, and Day 15
ODS "Improved" at Day 8 and Day 15
The percentage of subjects rated "improved" with respect to ODS at Days 8 and 15. "Improved" is defined as at least a 2 grade decrease in ODS score relative to baseline. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe.
Time frame: baseline, Day 8, and Day 15
"Treatment Success" for Clinical Signs and Symptoms of Psoriasis
The percentage of subjects rated "treatment success" for each of the clinical signs and symptoms of psoriasis (scaling, erythema, plaque elevation) at Days 8 and 15. "Treatment success" is defined as a score of 0 or 1 based on a 5-point ordinal scale where 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe.
Time frame: baseline, Day 8 and Day 15
"Improved" for Clinical Signs and Symptoms of Psoriasis
The percentage of subjects rated "improved" for each of the clinical signs and symptoms of psoriasis (scaling, erythema, plaque elevation, pruritus) at Days 8 and 15. "Improved" is defined as at least a 2 grade decrease in score based on a 5-point ordinal scale where 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe.
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Time frame: baseline, Day 8 and Day 15
Change in % Body Surface Area (BSA) With Psoriasis
Changes in % BSA with active psoriasis in the Treatment Area at Days 8 and 15.
Time frame: baseline, Day 8 and Day 15