A Phase 2 study evaluating safety, tolerability, and efficacy of SNA-120 ointment when administered topically with calcipotriene ointment for the treatment of pruritus and psoriasis.
All subjects are required to meet eligibility requirements and undergo a calcipotriene run-in period (Part A) prior to qualifying and randomizing into the study to receive either SNA-120 or Placebo ointment in combination with calcipotriene ointment (Part B). Combination therapy (SNA-120 ointment + calcipotriene ointment or Placebo ointment + calcipotriene ointment) is to continue over an 8 week period to evaluate safety, tolerability and the efficacy of treatment on both persistent pruritus and the visible signs and symptoms of psoriasis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
73
SNA-120 (0.5%) active ointment
Vehicle Ointment
Calcipotriene ointment (0.005%)
Sienna 018
Anniston, Alabama, United States
Sienna 009
Mobile, Alabama, United States
Change in Itch Numeric Rating Scale scores (I-NRS) from baseline
11-point NRS scale used to assess pruritus severity, ranging from 0 (no itching at all) to 10 (worst possible itching)
Time frame: week 8
Change in Investigator Global Assessment (IGA) from baseline
5-point scale used to assess the overall severity of psoriasis by evaluting induration, erythema and desquamation (0=clear to 4=severe)
Time frame: week 8
Change in Psoriasis Area Severity Index (PASI) from baseline
A quantitative rating score for measuring the severity of psoriatic lesions based on area coverage and plaque appearance (0 = no disease to 72 = maximum disease)
Time frame: week 8
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Sienna 019
Fountain Valley, California, United States
Sienna 007
Los Angeles, California, United States
Site 016
Sherman Oaks, California, United States
Site 013
Coral Gables, Florida, United States
Site 015
Sanford, Florida, United States
Site 012
Indianapolis, Indiana, United States
Sienna 011
Warren, Michigan, United States
Sienna 005
Berlin, New Jersey, United States
...and 10 more locations