ZORYVE (roflumilast) topical cream 0.15%

For age 6+

Not a steroid. No boxed warning

Study Design

STUDIED IN A PATIENT POPULATION THAT LOOKS LIKE YOUR PRACTICE

One cream. Once a day. Anywhere.1

INTEGUMENT-1 and INTEGUMENT-2 pivotal study designs1:

  • Two Phase 3, multicenter, randomized, double-blind, vehicle-controlled studies (INTEGUMENT-1 and -2)
  • 1337 participants with mild to moderate atopic dermatitis ages 6 years and older
    • ZORYVE = 884, vehicle = 453
  • Once daily for 4 weeks

QD = Once daily.

See Eligibility Criteria

No concomitant therapies or other moisturizers/emollients were allowed on treated areas3

Primary Endpoint

Key Secondary
Endpoints

vIGA-AD Success at Week 4

  • Achievement of vIGA-AD score of Clear (0) or Almost Clear (1) and ≥2-grade improvement from baseline1

vIGA-AD = Validated Investigator Global Assessment-Atopic Dermatitis.

WI-NRS Success at Weeks 1, 2, and 4

  • Achievement of a ≥4-point improvement for patients with a baseline score ≥41

EASI-75 at Week 4

  • Achievement of a 75% reduction in EASI score from baseline2

vIGA-AD score of Clear or Almost Clear

  • Achievement of a vIGA-AD of 0 or 12

EASI = Eczema Area and Severity Index. vIGA-AD = Validated Investigator Global Assessment-Atopic Dermatitis. WI-NRS = Worst Itch Numeric Rating Scale. WI-NRS: 0 (no itch) to 10 (worst imaginable itch).

Studied in a diverse patient population with mild to moderate atopic dermatitis1,4

  • Up to 88% BSA (range: 3%-88%; mean: 14%)1
  • Age range: 6–91 years old (mean: 28 years)1
  • Evaluated across race, ethnicities, and skin types (54% lighter skin; 46% darker skin)4*

*60% White; 40% non-White (20% African American, 13% Asian); 54% Fitzpatrick I–III, 46% Fitzpatrick IV–VI.

BSA = Body Surface Area.

See Efficacy Data

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View Safety Profile

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