Hand holding tube of ZORYVE cream

Actor portrayal

Hand holding tube of ZORYVE cream

Actor portrayal

 Study Design

STUDIED ACROSS MULTIPLE CLINICAL PRESENTATIONS

 

DERMIS-1 and DERMIS-2 study design:

Two Phase 3 randomized, parallel, double-blind, vehicle-controlled, multicenter studies

881 participants with plaque psoriasis  – ZORYVE = 576, vehicle = 305

Once daily for 8 weeks

7% mean BSA involvement (range: 2%-20%)1,7

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

No concomitant therapies or other moisturizers/emollients were allowed on treated areas7

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 reduction of at least 4 points in subjects with a WI-NRS score of 4 or higher 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)7

Elbows: 72% of participants

ELBOWS
72%

Knees: 58% of participants

KNEES
58%

Face: 27% of participants

FACIAL
27%

Intertriginous Areas: 21% of participants

INTERTRIGINOUS
AREAS 21%

Actual clinical trial patients

 

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

MILD16%
MODERATE76%
SEVERE8%

77% reported itch

with a baseline WI-NRS ≥4 (mean = 7.0)1,7

77% REPORTED ITCH with a baseline WI-NRS ≥4 (mean = 7.0)1,7

BSA = Body Surface Area.

WI-NRS = Worst Itch Numeric Rating Scale.