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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.

Vehicle QD(N=305)8 weeksZORYVE (roflumilast) cream 0.3% QD(N=576)N=881Randomized2:1
See eligibility criteria

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

Body areas figure

27%

face

21%

intertriginous areas

72%

elbows

16%

genitalia

58%

knees

Studied across all disease severities (IGA score at baseline)1

MILD16%
MODERATE76%
SEVERE8%

7% MEAN BSA
involvement (range: 2%–20%)1,3

77% REPORTED ITCH
with a baseline WI-NRS ≥4 (mean = 7.0)1,3

*Scalp excluded. Treatment of palms and soles excluded from efficacy analysis.

BSA = Body Surface Area.

WI-NRS = Worst Itch Numeric Rating Scale.