This phase 3, double-blind, vehicle-controlled study assessed the safety and efficacy of roflumilast (ARQ-154) foam 0.3% applied once daily (qd) for 8 weeks by participants with seborrheic dermatitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
457
Roflumilast 0.3% foam for topical application
Vehicle foam for topical application
Achievement of Success on the Investigator Global Assessment (IGA) at Week 8
The percentage of participants achieving IGA "success" is presented. Success is defined as a score of 0 ('clear') or 1 ('almost clear') plus a 2-point improvement at Week 8. The IGA is 5-point scale assessing the severity of seborrheic dermatitis with total scores ranging from 0 ('clear') to 4 ('severe') \[higher scores indicating greater severity\].
Time frame: Week 8
Achievement of Success in the Worst Itch Numeric Rating Scale (WI-NRS) at Week 8
The percentage of participants achieving WI-NRS "success" is presented. The WI-NRS is a simple, single-item scale to assess the participant-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the participants experienced in the previous 24 hours (higher scores indicate higher itch severity). The endpoint is the average of daily assessments reported during each study week, and requires at least 4 daily assessments reported during the week. In participants with a weekly average baseline pruritus score of ≥4, "success" is defined as achievement of a ≥4-point improvement from baseline in weekly average WI-NRS pruritus score at Week 8.
Time frame: Week 8
Achievement of Success in the WI-NRS at Week 4
The percentage of participants achieving WI-NRS "success" is presented. The WI-NRS is a simple, single-item scale to assess the participant-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the participants experienced in the previous 24 hours (higher scores indicate higher itch severity). The endpoint is the average of daily assessments reported during each study week, and requires at least 4 daily assessments reported during the week. In participants with a weekly average baseline pruritus score of ≥4, "success" is defined as achievement of a ≥4-point improvement from baseline in weekly average WI-NRS pruritus score at Week 4.
Time frame: Week 4
Achievement of Success in the WI-NRS at Week 2
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Arcutis Biotherapeutics Clinical Site 01
Scottsdale, Arizona, United States
Arcutis Biotherapeutics Clinical Site 45
Encinitas, California, United States
Arcutis Biotherapeutics Clinical Site 46
San Diego, California, United States
Arcutis Biotherapeutics Clinical Site 64
San Diego, California, United States
Arcutis Biotherapeutics Clinical Site 21
Santa Monica, California, United States
Arcutis Biotherapeutics Clinical Site 42
Coral Gables, Florida, United States
Arcutis Biotherapeutics Clinical Site 57
Delray Beach, Florida, United States
Arcutis Biotherapeutics Clinical Site 33
Largo, Florida, United States
Arcutis Biotherapeutics Clinical Site 31
North Miami Beach, Florida, United States
Arcutis Biotherapeutics Clinical Site 65
Sanford, Florida, United States
...and 43 more locations
The percentage of participants achieving WI-NRS "success" is presented. In participants with a weekly average baseline pruritus score of ≥4, "success" is defined as achievement of a ≥4-point improvement from baseline in weekly average WI-NRS pruritus score at Week 2. The endpoint is the average of daily assessments reported during each study week, and requires at least 4 daily assessments reported during the week. The WI-NRS is a simple, single-item scale to assess the participant-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the participants experienced in the previous 24 hours (higher scores indicate higher itch severity).
Time frame: Week 2
Achievement of Success on the IGA at Week 2
The percentage of participants achieving WI-NRS "success" is presented. The WI-NRS is a simple, single-item scale to assess the participant-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the participants experienced in the previous 24 hours (higher scores indicate higher itch severity). The endpoint is the average of daily assessments reported during each study week, and requires at least 4 daily assessments reported during the week. In participants with a weekly average baseline pruritus score of ≥4, "success" is defined as achievement of a ≥4-point improvement from baseline in weekly average WI-NRS pruritus score at Week 2.
Time frame: Week 2
Achievement of Success on the IGA at Week 4
The percentage of participants achieving IGA "success" is presented. Success is defined as a score of 0 ('clear') or 1 ('almost clear') plus a 2-point improvement at Week 8. The IGA is 5-point scale assessing the severity of seborrheic dermatitis with total scores ranging from 0 ('clear') to 4 ('severe') \[higher scores indicating greater severity\].
Time frame: Week 4
Achievement of Overall Assessment of Scaling Score of 0 at Week 8
The percentage of participants achieving Overall Assessment of Scaling score of 0 at Week 8 is presented. The Overall Assessment of Scaling is a simple, single-item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("No scaling: No scaling evident on lesions.") to 3 ("Severe: Coarse, thick scales, with flaking into clothes or skin."). Higher scores indicate greater symptom severity.
Time frame: Week 8
Achievement of Overall Assessment of Erythema Score of 0 at Week 8
The percentage of participants achieving Overall Assessment of Erythema score of 0 at Week 8 is presented. The Erythema Assessment is a simple, single-item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("None: no evidence of erythema.") to 3 ("Severe: Intense \[fiery red\] erythema."). Higher scores indicate greater severity.
Time frame: Week 8