Study Design
ZORYVE pivotal trials were designed with clearance in mind
Study Design1
DERMIS-1 and DERMIS-2 were identical Phase 3 randomized, parallel, double-blind, vehicle-controlled, multicenter studies that evaluated ZORYVE over 8 weeks as a once-daily, topical treatment for plaque psoriasis.
- Diagnosis of mild, moderate, or severe plaque psoriasis
- 2%–20% BSA
BSA = Body Surface Area.
Primary Endpoint
Key Secondary Endpoints
IGA Success at WEEK 8
Achievement of an IGA score of clear/almost clear and a ≥2-grade improvement from baseline
IGA = Investigator Global Assessment.
I-IGA Success at WEEK 8
Achievement of an I-IGA score of clear/almost clear and a ≥2-grade improvement from baseline
WI-NRS Success at WEEKS 8, 4, and 2
Achievement of a ≥4-point reduction among subjects with a WI-NRS score ≥4 at baseline
I-IGA = Intertriginous Investigator Global Assessment.
WI-NRS = Worst Itch Numeric Rating Scale.
DERMIS-1 and DERMIS-2 study participants reflected everyday patients
Participants presented with multiple affected body areas
(N=881)3
27%
face
21%
intertriginous areas
72%
elbows
16%
genitalia
58%
knees
Studied across all disease severities (IGA score at baseline)1
7% MEAN BSA
involvement (range: 2%–20%)1,3
77% REPORTED ITCH
with a baseline WI-NRS ≥4 (mean = 7.0)1,3
BSA = Body Surface Area.
WI-NRS = Worst Itch Numeric Rating Scale.