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
See Eligibility Criteria
- Mild to moderate atopic
dermatitis (vIGA-AD=2 or 3) - ≥6 years old
- EASI score ≥5
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.