Phase III Efficacy and Safety Study of RSS0393 Ointment in Plaque Psoriasis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
600
RSS0393 ointment 0.03%
RSS0393 ointment placebo
Peking Union Medical College Hospital (PUMCH)
Beijing, Beijing Municipality, China
Achieving a Physician's Global Assessment (PGA) response at Week 8
Time frame: week8
The proportion of participants achieving at least a 75% improvement frombaseline in the Psoriasis Area and Severity Index (PASI) score (PASI 75).
Time frame: week54
The proportion of participants with a baseline Itch Numerical Rating Scale (Itch-NRS) score ≥4 who achieved an Itch-NRS response (defined as a reduction of ≥4 points from baseline).
Time frame: week54
Achieving an Intertriginous Physician's Global Assessment (I-PGA) response in participants with baseline involvement of intertriginous areas and a baseline I-PGA score ≥ 2.
Time frame: week54
The proportion of participants achieving a Physician's Global Assessment (PGA) response (score of "clear" or "almost clear") at each of the other scheduled visits.
Time frame: week 54
Change from baseline in Psoriasis Area and Severity Index (PASI) score (absolute and percentage) at each visit.
Time frame: week 54
The proportion of participants achieving PASI 50, PASI 90, or PASI 100 at each visit.
Time frame: week 54
Change from baseline in the Itch Numerical Rating Scale (Itch-NRS) score (absolute and percentage) at each visit.
Time frame: week 54
Change from baseline in Body Surface Area (BSA) involvement (absolute and percentage) at each visit.
Time frame: week 54
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Change from baseline in the Dermatology Life Quality Index (DLQI) at each visit.
Time frame: week 54
Adverse Event (AE)
Time frame: week 54
Local Tolerability Score
Time frame: week 54