To characterize the efficacy, safety and tolerability of SNA-120 at 2 doses versus placebo when administered topically for the treatment of pruritus associated with psoriasis vulgaris (PV) and PV itself.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
208
Change in Itch Numeric Rating Scale scores (I-NRS)
The I-NRS is a 11 point scale, where "0" represents no itch and "10" represents worst possible itching
Time frame: week 1
Change in Itch Numeric Rating Scale scores (I-NRS)
The I-NRS is a 11 point scale, where "0" represents no itch and "10" represents worst possible itching
Time frame: week 2
Change in Itch Numeric Rating Scale scores (I-NRS)
The I-NRS is a 11 point scale, where "0" represents no itch and "10" represents worst possible itching
Time frame: week 4
Change in Itch Numeric Rating Scale scores (I-NRS)
The I-NRS is a 11 point scale, where "0" represents no itch and "10" represents worst possible itching
Time frame: week 6
Change in Itch Numeric Rating Scale scores (I-NRS)
The I-NRS is a 11 point scale, where "0" represents no itch and "10" represents worst possible itching
Time frame: week 8
Proportion of subjects (≥ 1 grade change) on IGA scale
Investigator Global Assessment
Time frame: week 12
Proportion of subjects (≥ 2 grade change) on IGA scale
Investigator Global Assessment
Time frame: week 12
Proportion of subjects categorized as a "0" or "1" on IGA scale and minimum improvement of 2 categories
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Site 025
Scottsdale, Arizona, United States
Sienna 022
Fort Smith, Arkansas, United States
Site 028
Fountain Valley, California, United States
Sienna 009
Fremont, California, United States
Sienna 008
San Diego, California, United States
Sienna 020
Santa Monica, California, United States
Sienna 015
Denver, Colorado, United States
Sienna 005
Farmington, Connecticut, United States
Site 030
Shelton, Connecticut, United States
Site 026
Doral, Florida, United States
...and 28 more locations
Investigator Global Assessment
Time frame: baseline and week 12
Change in PASI-50
Percentage of subjects with 50% reductions in Psoriasis Area and Severity Index
Time frame: baseline and week 12