Trial of PDE4 Inhibition With Roflumilast (ARQ-154) Foam 0.3% for the Management of Seborrheic Dermatitis (STRATUM)
- Conditions
- Seborrheic Dermatitis
- Interventions
- 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
- 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
- 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 65
🇺🇸Sanford, Florida, United States
Arcutis Biotherapeutics Clinical Site 28
🇺🇸Rockville, Maryland, United States
Arcutis Biotherapeutics Clinical Site 42
🇺🇸Coral Gables, Florida, United States
Arcutis Biotherapeutics Clinical Site 22
🇺🇸Plainfield, Indiana, United States
Arcutis Biotherapeutics Clinical Site 23
🇺🇸High Point, North Carolina, United States
Arcutis Biotherapeutics Clinical Site 45
🇺🇸Encinitas, California, United States
Arcutis Biotherapeutics Clinical Site 14
🇺🇸Fridley, Minnesota, United States
Arcutis Biotherapeutics Clinical Site 18
🇺🇸Bexley, Ohio, United States
Arcutis Biotherapeutics Clinical Site 63
🇺🇸Bronx, New York, 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 16
🇨🇦London, Ontario, Canada
Arcutis Biotherapeutics Clinical Site 66
🇺🇸New York, New York, United States
Arcutis Biotherapeutics Clinical Site 13
🇺🇸Arlington, Texas, United States
Arcutis Biotherapeutics Clinical Site 08
🇺🇸Broomall, Pennsylvania, United States
Arcutis Biotherapeutics Clinical Site 30
🇨🇦North Bay, Ontario, Canada
Arcutis Biotherapeutics Clinical Site 41
🇺🇸College Station, Texas, United States
Arcutis Biotherapeutics Clinical Site 57
🇺🇸Delray Beach, Florida, United States
Arcutis Biotherapeutics Clinical Site 27
🇺🇸Pittsburgh, Pennsylvania, United States
Arcutis Biotherapeutics Clinical Site 17
🇺🇸Norfolk, Virginia, United States
Arcutis Biotherapeutics Clinical Site 35
🇨🇦Calgary, Alberta, Canada
Arcutis Biotherapeutics Clinical Site 21
🇺🇸Santa Monica, California, United States
Arcutis Biotherapeutics Clinical Site 02
🇺🇸Rockville, Maryland, United States
Arcutis Biotherapeutics Clinical Site 44
🇺🇸Saint Joseph, Missouri, United States
Arcutis Biotherapeutics Clinical Site 19
🇺🇸Reno, Nevada, United States
Arcutis Biotherapeutics Clinical Site 11
🇺🇸Austin, Texas, United States
Arcutis Biotherapeutics Clinical Site 26
🇺🇸Pflugerville, Texas, United States
Arcutis Biotherapeutics Clinical Site 07
🇺🇸West Jordan, Utah, United States
Arcutis Biotherapeutics Clinical Site 37
🇨🇦Surrey, British Columbia, Canada
Arcutis Biotherapeutics Clinical Site 29
🇨🇦Mississauga, Ontario, Canada
Arcutis Biotherapeutics Clinical Site 32
🇨🇦Peterborough, Ontario, Canada
Arcutis Biotherapeutics Clinical Site 36
🇨🇦Waterloo, Ontario, Canada
Arcutis Biotherapeutics Clinical Site 03
🇺🇸Indianapolis, Indiana, United States
Arcutis Biotherapeutics Clinical Site 60
🇺🇸Houston, Texas, 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 47
🇨🇦Winnipeg, Manitoba, Canada
Arcutis Biotherapeutics Clinical Site 43
🇨🇦Fredericton, New Brunswick, Canada
Arcutis Biotherapeutics Clinical Site 40
🇺🇸Clinton Township, Michigan, United States
Arcutis Biotherapeutics Clinical Site 34
🇺🇸East Windsor, New Jersey, United States
Arcutis Biotherapeutics Clinical Site 01
🇺🇸Scottsdale, Arizona, United States
Arcutis Biotherapeutics Clinical Site 06
🇺🇸Knoxville, Tennessee, United States
Arcutis Biotherapeutics Clinical Site 04
🇺🇸Lake Charles, Louisiana, United States
Arcutis Biotherapeutics Clinical Site 10
🇺🇸Rolling Meadows, Illinois, United States
Arcutis Biotherapeutics Clinical Site 72
🇺🇸Plano, Texas, United States
Arcutis Biotherapeutics Clinical Site 12
🇺🇸Tampa, Florida, United States
Arcutis Biotherapeutics Clinical Site 15
🇺🇸Louisville, Kentucky, United States
Arcutis Biotherapeutics Clinical Site 20
🇺🇸Detroit, Michigan, United States
Arcutis Biotherapeutics Clinical Site 70
🇺🇸Winston-Salem, North Carolina, United States
Arcutis Biotherapeutics Clinical Site 71
🇺🇸Portland, Oregon, United States
Arcutis Biotherapeutics Clinical Site 54
🇺🇸San Antonio, Texas, United States
Arcutis Biotherapeutics Clinical Site 24
🇺🇸San Antonio, Texas, United States
Arcutis Biotherapeutics Clinical Site 09
🇨🇦Westmount, Quebec, Canada