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Study Design
A FOAM TO ADDRESS THE DIVERSE NEEDS OF SEBORRHEIC DERMATITIS PATIENTS
FIRST-IN-CLASS FOR SEBORRHEIC DERMATITIS2
STRATUM and Trial 203 pivotal study designs1,2:
- Two multicenter, randomized, double-blind, vehicle-controlled studies
- 683 participants with moderate to severe seborrheic dermatitis
- STRATUM: ZORYVE foam = 304, vehicle = 153
- Trial 203: ZORYVE foam = 154, vehicle = 72
- Once daily for 8 weeks
No concomitant therapies or other moisturizers/emollients were allowed on treated areas2
- Diagnosis of moderate (IGA = 3) or severe (IGA = 4) seborrheic dermatitis
- Age ≥9 years in STRATUM and ≥18 years in Trial 203
- ≤20% BSA
- Stable disease for the past 4 weeks
BSA = Body Surface Area.
73% of patients had involvement in multiple areas in STRATUM2
SCALP
FACIAL
EYELIDS
EARS
TRUNK
Actual clinical trial patients
Primary Endpoint
Key Secondary Endpoints
In STRATUM
IGA Success
(Clear or Almost Clear)
at WEEK 8
Achievement of an IGA score of Clear/Almost Clear and a ≥2-grade improvement from baseline
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IGA = Investigator Global Assessment.
Completely Clear at WEEK 8
Achievement of completely Clear skin (IGA = 0)
WI-NRS Success (Itch Improvement) at WEEK 8
Achievement of a ≥4-point improvement for patients with a baseline score of ≥4
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IGA = Investigator Global Assessment.
WI-NRS = Worst-Itch Numeric Rating Scale.