Clinical trial NCT04973228: Trial of PDE4 Inhibition With Roflumilast (ARQ-154) Foam 0.3% for the Management of Seborrheic Dermatitis (STRATUM)
Official title: A Phase 3, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-154 Foam 0.3% Administered QD in Subjects With Seborrheic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seborrheic Dermatitis
Lead sponsor: Arcutis Biotherapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-07-22
Enrollment: 457
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Key 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.

Primary outcomes:
measure: Achievement of Success on the Investigator Global Assessment (IGA) at Week 8
timeFrame: Week 8
Secondary outcomes:
measure: Achievement of Success in the Worst Itch Numeric Rating Scale (WI-NRS) at Week 8
timeFrame: Week 8
measure: Achievement of Success in the WI-NRS at Week 4
timeFrame: Week 4
measure: Achievement of Success in the WI-NRS at Week 2
timeFrame: Week 2
measure: Achievement of Success on the IGA at Week 2
timeFrame: Week 2
measure: Achievement of Success on the IGA at Week 4
timeFrame: Week 4
measure: Achievement of Overall Assessment of Scaling Score of 0 at Week 8
timeFrame: Week 8
measure: Achievement of Overall Assessment of Erythema Score of 0 at Week 8
timeFrame: Week 8
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Arcutis Biotherapeutics Clinical Site 01
state: Arizona
city: Encinitas
country: United States
facility: Arcutis Biotherapeutics Clinical Site 45
state: California
city: San Diego
country: United States
facility: Arcutis Biotherapeutics Clinical Site 46
state: California
city: San Diego
country: United States
facility: Arcutis Biotherapeutics Clinical Site 64
state: California
city: Santa Monica
country: United States
facility: Arcutis Biotherapeutics Clinical Site 21
state: California
city: Coral Gables
country: United States
facility: Arcutis Biotherapeutics Clinical Site 42
state: Florida
city: Delray Beach
country: United States
facility: Arcutis Biotherapeutics Clinical Site 57
state: Florida
city: Largo
country: United States
facility: Arcutis Biotherapeutics Clinical Site 33
state: Florida
city: North Miami Beach
country: United States
facility: Arcutis Biotherapeutics Clinical Site 31
state: Florida
city: Sanford
country: United States
facility: Arcutis Biotherapeutics Clinical Site 65
state: Florida
city: Tampa
country: United States
facility: Arcutis Biotherapeutics Clinical Site 12
state: Florida
city: Rolling Meadows
country: United States
facility: Arcutis Biotherapeutics Clinical Site 10
state: Illinois
city: Indianapolis
country: United States
facility: Arcutis Biotherapeutics Clinical Site 03
state: Indiana
city: Plainfield
country: United States
facility: Arcutis Biotherapeutics Clinical Site 22
state: Indiana
city: Louisville
country: United States
facility: Arcutis Biotherapeutics Clinical Site 15
state: Kentucky
city: Lake Charles
country: United States
facility: Arcutis Biotherapeutics Clinical Site 04
state: Louisiana
city: Rockville
country: United States
facility: Arcutis Biotherapeutics Clinical Site 02
state: Maryland
city: Rockville
country: United States
facility: Arcutis Biotherapeutics Clinical Site 28
state: Maryland
city: Clinton Township
country: United States
facility: Arcutis Biotherapeutics Clinical Site 40
state: Michigan
city: Detroit
country: United States
facility: Arcutis Biotherapeutics Clinical Site 20
state: Michigan
city: Fridley
country: United States
facility: Arcutis Biotherapeutics Clinical Site 14
state: Minnesota
city: Saint Joseph
country: United States
facility: Arcutis Biotherapeutics Clinical Site 44
state: Missouri
city: Reno
country: United States
facility: Arcutis Biotherapeutics Clinical Site 19
state: Nevada
city: East Windsor
country: United States
facility: Arcutis Biotherapeutics Clinical Site 34
state: New Jersey
city: Bronx
country: United States
facility: Arcutis Biotherapeutics Clinical Site 63
state: New York
city: New York
country: United States
facility: Arcutis Biotherapeutics Clinical Site 66
state: New York
city: High Point
country: United States
facility: Arcutis Biotherapeutics Clinical Site 23
state: North Carolina
city: Winston-Salem
country: United States
facility: Arcutis Biotherapeutics Clinical Site 70
state: North Carolina
city: Bexley
country: United States
facility: Arcutis Biotherapeutics Clinical Site 18
state: Ohio
city: Portland
country: United States
facility: Arcutis Biotherapeutics Clinical Site 71
state: Oregon
city: Broomall
country: United States
facility: Arcutis Biotherapeutics Clinical Site 08
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Arcutis Biotherapeutics Clinical Site 27
state: Pennsylvania
city: Knoxville
country: United States
facility: Arcutis Biotherapeutics Clinical Site 06
state: Tennessee
city: Arlington
country: United States
facility: Arcutis Biotherapeutics Clinical Site 13
state: Texas
city: Austin
country: United States
facility: Arcutis Biotherapeutics Clinical Site 11
state: Texas
city: College Station
country: United States
facility: Arcutis Biotherapeutics Clinical Site 41
state: Texas
city: Houston
country: United States
facility: Arcutis Biotherapeutics Clinical Site 60
state: Texas
city: Pflugerville
country: United States
facility: Arcutis Biotherapeutics Clinical Site 26
state: Texas
city: Plano
country: United States
facility: Arcutis Biotherapeutics Clinical Site 72
state: Texas
city: San Antonio
country: United States
facility: Arcutis Biotherapeutics Clinical Site 54
state: Texas
city: San Antonio
country: United States
facility: Arcutis Biotherapeutics Clinical Site 24
state: Texas
city: West Jordan
country: United States
facility: Arcutis Biotherapeutics Clinical Site 07
state: Utah
city: Norfolk
country: United States
facility: Arcutis Biotherapeutics Clinical Site 17
state: Virginia
city: Calgary
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 35
state: Alberta
city: Surrey
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 37
state: British Columbia
city: Winnipeg
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 47
state: Manitoba
city: Fredericton
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 43
state: New Brunswick
city: London
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 16
state: Ontario
city: Mississauga
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 29
state: Ontario
city: North Bay
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 30
state: Ontario
city: Peterborough
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 32
state: Ontario
city: Waterloo
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 36
state: Ontario
city: Westmount
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 09
state: Quebec
Study officials:
affiliation: Arcutis Biotherapeutics, Inc.
name: David Berk, MD
role: STUDY_DIRECTOR
References: