This is an open-label, long-term safety study of roflumilast ARQ-154 foam 0.3% in subjects with seborrheic dermatitis involving up to 20% total Body Surface Area (BSA). Study was applied topically once daily for 52 weeks. Cohort 1 subjects are rollover subjects from study ARQ-154-203 (NCT04091646) and were rolled into treatment in the current study without interruption. Cohort 2 includes participants from ARQ-154-203 who began treatment in the current study after a gap from completing treatment in the prior study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
408
ARQ-154 foam 0.3% applied once daily for 52 weeks
Number of Participants With ≥1 Adverse Event (AE)
The number of participants with treatment-emergent AEs is reported. An AE is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to participation in the research. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.
Time frame: Up to 52 weeks
Number of Participants With ≥1 Serious Adverse Event (SAE)
The number of participants with treatment-emergent SAEs is reported. An SAE is any AE that results in death, is life-threatening (places the subject at immediate risk of death from the event as it occurred), requires inpatient hospitalization or prolongation of existing hospitalization, results in a persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is any other adverse event that, based upon appropriate medical judgment, may jeopardize the subject's health. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.
Time frame: Up to 52 weeks
Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear
The number of participants with an IGA score of 0 ('completely clear') or 1 ('almost clear') is presented. The IGA is a 5-point scale assessing the severity of seborrheic dermatitis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity.
Time frame: Weeks 4, 12, 24, 36, and 52
Achievement of IGA Success
The number of participants achieving "success" in IGA assessment of disease severity is presented. Success was defined as achievement of an IGA score of 0 ('clear') or 1 ('almost clear') at Week 8, accompanied by a ≥2-grade improvement from baseline IGA score. The IGA is a 5-point scale assessing the severity of seborrheic dermatitis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity.
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Arcutis Biotherapeutics Clinical Site 59
Beverly Hills, California, United States
Arcutis Biotherapeutics Clinical Site 51
Encino, California, United States
Arcutis Biotherapeutics Clinical Site 75
Fountain Valley, California, United States
Arcutis Biotherapeutics Clinical Site 19
Fremont, California, United States
Arcutis Biotherapeutics Clinical Site 62
Los Angeles, 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 53
Aventura, Florida, United States
Arcutis Biotherapeutics Clinical Site 42
Coral Gables, Florida, United States
Arcutis Biotherapeutics Clinical Site 57
Delray Beach, Florida, United States
...and 29 more locations
Time frame: Weeks 4, 12, 24, 36, and 52
Duration of IGA Success
The duration of "success" in IGA assessment of disease severity is presented. Success was defined as achievement of an IGA score of 0 ('clear') or 1 ('almost clear') at Week 8, accompanied by a ≥2-grade improvement from baseline IGA score. The IGA is a 5-point scale assessing the severity of seborrheic dermatitis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity. The time from first observation of IGA success to the first subsequent time a participant's disease response did not meet the criteria for IGA success is presented. The duration of IGA success for subjects who ended treatment in IGA success was censored at the last disease assessment date.
Time frame: Weeks 4, 12, 24, 36, and 52
IGA Treatment-Free Interval
The treatment-free interval is defined as time from when the participant achieves disease clearance (IGA score of 0 \["completely clear"\]) and stops treatment of all lesions until the time of restarting treatment.
Time frame: Weeks 4, 12, 24, 36, and 52