Abstract
Psoriasis Area and Severity Index (PASI), a gold standard measure in psoriasis clinical trials, lacks sensitivity in affected areas <10%; it does not distinguish disease regardless of severity in cases of low Body Surface Area (BSA). PASI-HD was developed to obtain higher discrimination in low BSA using the actual percentage of involvement of each anatomical area. PASI and PASI-HD were assessed in a randomized, vehicle-controlled, phase 2b, 12-week study of once-daily roflumilast cream. Patients with chronic plaque psoriasis were randomized to roflumilast 0.3% (n = 109), roflumilast 0.15% (n = 113), or vehicle (n = 109).
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