Clinical trial NCT04091646: Safety and Efficacy of ARQ-154 Foam in Subjects With Seborrheic Dermatitis
Official title: A Phase 2b, 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: PHASE2
Conditions: Seborrheic Dermatitis
Lead sponsor: Arcutis Biotherapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-09-17
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Participants legally competent to sign and give informed consent.
2. Males and females ages 18 years and older (inclusive) at the time of consent.
3. Clinical diagnosis of seborrheic dermatitis of at least 3 months duration as determined by the Investigator. Stable disease for the past 4 weeks.
4. Seborrheic dermatitis of the scalp and/or face and/or trunk and/or intertriginous areas.
5. An Investigator Global Assessment (IGA) of disease severity of at least Moderate ('3') at Baseline.
6. Overall Assessment of Erythema and Overall Assessment of Scaling scores of at least Moderate ('2') at Baseline.
7. 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).
8. Females of non-childbearing potential must either be post-menopausal with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization.
9. Subjects in good health as judged by the Investigator, based on medical history, physical examination, vital signs, serum chemistry labs, hematology values, and urinalysis.
10. Subjects are considered reliable and capable of adhering to the Protocol and visit schedule according to the Investigator judgment.

Exclusion Criteria:

1. Subjects who cannot discontinue treatment with therapies for the treatment of seborrheic dermatitis prior to the Baseline visit and during the study according to Excluded Medications and Treatments.
2. Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
3. Subjects who cannot discontinue the use of strong P-450 cytochrome inhibitors e.g., indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, suboxone and telithromycin for two weeks prior to the Baseline visit (Visit 2) and during the study.
4. Subjects who cannot discontinue the use of strong P-450 cytochrome inducers e.g., efavirenz, nevirapine, glucocorticoids, barbiturates (including phenobarbital), phenytoin, rifampin, and carbamazepine for two weeks prior to the Baseline visit (Visit 2) and during the study.
5. Subjects with PHQ-8 ≥10 at Screening or Baseline visits.
6. Previous treatment with ARQ-151 and ARQ-154.
7. Subjects who have received oral roflumilast (Daliresp®, Daxas®) or other PDE-4 inhibitors (apremilast) within the past 4 weeks.
8. Known allergies to excipients in ARQ-154 foam.
9. Known or suspected: severe renal insufficiency or moderate to severe hepatic disorders; hypersensitivity to component(s) of the investigational products; or history of severe depression, suicidal ideation, or Baseline/Screening C-SSRS indicative of suicidal ideation, whether lifetime or recent/current.
10. Subjects with a history of a major surgery within 8 weeks prior to Baseline (Visit 2) or has a major surgery planned during the study.
11. Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements.
12. Subjects unable to apply product to the scalp due to physical limitations.
13. Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
14. A clinically relevant history of abuse of alcohol or other drugs, at the discretion of the Investigator.
15. Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation.
16. Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled subjects.
17. Any condition that in the Investigator's assessment would preclude the subject from participating in the study.

Primary outcomes:
measure: Achievement of Investigator Global Assessment (IGA) Success at Week 8
timeFrame: Week 8
Secondary outcomes:
measure: Achievement of IGA Success at Weeks 2 and 4
timeFrame: Weeks 2 and 4
measure: Change From Baseline in Overall Assessment of Erythema Score
timeFrame: Weeks 2, 4, and 8
measure: Achievement of Overall Assessment of Erythema Success
timeFrame: Weeks 2, 4, and 8
measure: Change From Baseline in Overall Assessment of Scaling Score
timeFrame: Weeks 2, 4, and 8
measure: Achievement of Overall Assessment of Scaling Success
timeFrame: Weeks 2, 4, and 8
measure: Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score
timeFrame: Weeks 2, 4, and 8
measure: Achievement of WI-NRS Success
timeFrame: Weeks 2, 4, and 8
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Arcutis Biotherapeutics Clinical Site 19
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: Miami
country: United States
facility: Arcutis Biotherapeutics Clinical Site 24
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: 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: 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: High Point
country: United States
facility: Arcutis Biotherapeutics Clinical Site 23
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 29
state: Oregon
city: Pittsburgh
country: United States
facility: Arcutis Biotherapeutics Clinical Site 27
state: Pennsylvania
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 25
state: Texas
city: Pflugerville
country: United States
facility: Arcutis Biotherapeutics Clinical Site 26
state: Texas
city: Norfolk
country: United States
facility: Arcutis Biotherapeutics Clinical Site 17
state: Virginia
city: Markham
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 31
state: Ontario
city: Windsor
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 30
state: Ontario
Study officials:
affiliation: Arcutis Biotherapeutics, Inc.
name: David Berk, MD
role: STUDY_DIRECTOR
References: