Trial of PDE4 Inhibition With Roflumilast (ARQ-154) Foam 0.3% for the Management of Seborrheic Dermatitis (STRATUM)

Phase 3

Completed

Conditions: Seborrheic Dermatitis

Interventions: Drug: Roflumilast Foam
Drug: Vehicle Foam

Registration Number: NCT04973228

Lead Sponsor: Arcutis Biotherapeutics, Inc.

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 457

Inclusion Criteria

Participants legally competent to sign and give informed consent and, if appropriate, assent as required by local laws.
Males and females ages 9 years and older at the time of consent.
Clinical diagnosis of seborrheic dermatitis of at least 3 months duration at Screening as determined by the Investigator. Stable disease for the past 4 weeks.
Seborrheic dermatitis up to 20% BSA involvement. Involvement may be of the scalp and/or face and/or trunk and/or intertriginous areas.
An Investigator Global Assessment (IGA) disease severity of at least Moderate ('3') at Baseline.
Overall Assessment of Erythema and Overall Assessment of Scaling scores of at least Moderate ('2') at Baseline.
Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening (Visit 1) and a negative urine pregnancy test at Baseline (Visit 2).
Females of non-childbearing potential must either be post-menopausal with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization.
Subjects in good health as judged by the Investigator.
Subjects are considered reliable and capable of adhering to the Protocol and visit schedule according to the Investigator judgment.

Key

Exclusion Criteria

Subjects who cannot discontinue treatment with therapies for the treatment of seborrheic dermatitis prior to the Baseline visit and during the study.
Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
Previous treatment with ARQ-154 or ARQ-151.
Subjects with any serious medical condition or clinically significant abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator.
Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Screening.
Subjects, parent(s)/legal guardian(s) who are unable to communicate, read, or understand the local language(s).
Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members living in the same house of enrolled subjects.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Roflumilast Foam 0.3%	Roflumilast Foam	Participants with seborrheic dermatitis apply roflumilast foam 0.3% once daily (QD) for 8 weeks.
Vehicle Foam	Vehicle Foam	Participants with seborrheic dermatitis apply vehicle foam QD for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Achievement of Success on the Investigator Global Assessment (IGA) at Week 8	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') \[higher scores indicating greater severity\].

Secondary Outcome Measures

Name	Time	Method
Achievement of Success on the IGA at Week 2	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.
Achievement of Success in the WI-NRS at Week 2	Week 2	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).
Achievement of Success on the IGA at Week 4	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') \[higher scores indicating greater severity\].
Achievement of Overall Assessment of Scaling Score of 0 at Week 8	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.
Achievement of Overall Assessment of Erythema Score of 0 at Week 8	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.
Achievement of Success in the Worst Itch Numeric Rating Scale (WI-NRS) at Week 8	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.
Achievement of Success in the WI-NRS at Week 4	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.

Trial Locations

Locations (53): 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
Scroll for more (43 remaining)
Arcutis Biotherapeutics Clinical Site 01
🇺🇸Scottsdale, Arizona, United States