ZORYVE (roflumilast) topical cream 0.15%
Once-daily & steroid-free, for patients down to 6 years old

STUDY DESIGN

STUDIED IN A PATIENT POPULATION THAT LOOKS LIKE YOUR PRACTICE

Actor portrayal

THE ONLY PRESCRIPTION TOPICAL WITHOUT PENETRATION ENHANCERS2

INTEGUMENT 1 & 2 pivotal study designs1,2:

  • Two Phase 3 multicenter, randomized, double-blind, vehicle-controlled studies (INTEGUMENT 1 & 2)
  • 1337 participants with mild to moderate atopic dermatitis ages 6 years and older
    • ZORYVE = 884, vehicle = 453
  • Once daily for 4 weeks
Grid showing INTEGUMENT 1 & 2 pivotal study designsZORYVE (ROFLUMILAST) CREAM 0.3 QD(n=884)VEHICLE QD(n=453)4 weeks2:1n=1337Randomized
Grid showing INTEGUMENT 1 & 2 pivotal study designsRandomizedZORYVE (roflumilast) cream 0.15% QD(n=884)Vehicle QD(n=453)2:1n=13374 weeks
See Eligibility Criteria

No concomitant therapies or other moisturizers/emollients were allowed on treated areas2

Primary Endpoint

Key Secondary
Endpoints

vIGA-AD Success at Week 4


  • Achievement of vIGA-AD score of Clear/Almost Clear and ≥2-grade improvement from baseline

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

WI-NRS Success at Weeks 4, 2, and 1

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

EASI-75 at Week 4

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

vIGA-AD score of Clear or Almost Clear

  • Achievement of a vIGA-AD of 0 or 1.

EASI = Eczema Area and Severity Index. vIGA-AD Success = Achievement of Clear/Almost Clear and a ≥2-grade improvement from baseline. WI-NRS = Worst Itch Numeric Rating Scale.

Studied in a diverse patient population with mild to moderate atopic dermatitis

  • 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)3*

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

BSA = Body Surface Area.