This was a parallel group, double blind, vehicle-controlled study assessed the safety and efficacy of roflumilast foam (ARQ-154) vs placebo foam in participants with seborrheic dermatitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
226
Roflumilast foam for topical application.
Vehicle foam for topical application.
Achievement of Investigator Global Assessment (IGA) Success at Week 8
The number of participants achieving "success" in IGA assessment of disease severity at Week 8 is presented for each arm. Success was defined as achievement of an IGA score of 0 ('completely clear') or 1 ('almost clear'), accompanied by a ≥2-grade improvement from baseline IGA score. The IGA is 5-point scale assessing the severity of Seborrheic Dermatitis, with scores ranging from 0 ('completely clear') to 4 ('severe'), and higher scores indicate greater severity. The IGA scores are based on observed data, whereas odds ratio and p-values were calculated using multiple imputation of missing values.
Time frame: Week 8
Achievement of IGA Success at Weeks 2 and 4
The number of participants achieving "success" in IGA assessment of disease severity at Weeks 2 and 4 is presented for each arm. Success was defined as achievement of an IGA score of 0 ('completely clear') or 1 ('almost clear'), accompanied by a ≥2-grade improvement from baseline IGA score. The IGA is 5-point scale assessing the severity of Seborrheic Dermatitis, with scores ranging from 0 ('completely clear') to 4 ('severe'), and higher scores indicate greater severity. The IGA scores are based on observed data, whereas odds ratio and p-values were calculated using multiple imputation of missing values.
Time frame: Weeks 2 and 4
Change From Baseline in Overall Assessment of Erythema Score
The mean (SD) change from baseline in Overall Assessment of Erythema score at Weeks 2, 4, and 8 is shown. 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: Weeks 2, 4, and 8
Achievement of Overall Assessment of Erythema Success
The number of participants achieving "success" in Overall Assessment of Erythema at Weeks 2, 4, and 8 is presented for each arm. Success was defined as achievement of an overall score of 0 or 1 plus a ≥2 grade improvement from Baseline. The Overall Assessment of Erythema 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.
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Arcutis Biotherapeutics Clinical Site 19
Fremont, 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 24
Miami, Florida, United States
Arcutis Biotherapeutics Clinical Site 12
Tampa, Florida, United States
Arcutis Biotherapeutics Clinical Site 10
Rolling Meadows, Illinois, United States
Arcutis Biotherapeutics Clinical Site 22
Plainfield, Indiana, United States
Arcutis Biotherapeutics Clinical Site 15
Louisville, Kentucky, United States
Arcutis Biotherapeutics Clinical Site 28
Rockville, Maryland, United States
Arcutis Biotherapeutics Clinical Site 40
Clinton Township, Michigan, United States
...and 14 more locations
Time frame: Weeks 2, 4, and 8
Change From Baseline in Overall Assessment of Scaling Score
The mean (SD) change from baseline in Overall Assessment of Scaling score at Weeks 2, 4, and 8 is shown. 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 severity.
Time frame: Weeks 2, 4, and 8
Achievement of Overall Assessment of Scaling Success
The number of participants achieving "success" in Overall Assessment of Scaling score at Weeks 2, 4, and 8 is presented for each arm. Success was defined as achievement of an Overall Assessment of Scaling score of 0 or 1 plus a ≥2 grade improvement from Baseline. 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 severity.
Time frame: Weeks 2, 4, and 8
Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score
The change from baseline in WI-NRS is shown. The WI-NRS is a simple, single-item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the subject experienced in the previous 24 hours. Negative values represent a decrease in worst itch from baseline, and positive values indicate an increase.
Time frame: Weeks 2, 4, and 8
Achievement of WI-NRS Success
The number of participants achieving WI-NRS "success" at Weeks 2, 4, and 8 is presented. Success was defined as achievement of a ≥4-point improvement from baseline WI-NRS score. The WI-NRS is a simple, single-item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the subject experienced in the previous 24 hours.
Time frame: Weeks 2, 4, and 8