Safety and Efficacy of ARQ-154 Foam in Subjects With Seborrheic Dermatitis

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

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.

Study Overview

• Status: Completed
• Conditions: Seborrheic Dermatitis
• Intervention / Treatment: Drug: Roflumilast Foam 0.3%; Drug: Vehicle foam

Detailed Description

This is a parallel group, double blind, vehicle-controlled study in which ARQ-154 foam or vehicle is applied once daily x 8 weeks to subjects with seborrheic dermatitis.

• Study Type: Interventional
• Enrollment (Actual): 226
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Markham, Ontario, Canada, L3P 1X2
      • Arcutis Biotherapeutics Clinical Site 31
    • Windsor, Ontario, Canada, N8W 1E6
      • Arcutis Biotherapeutics Clinical Site 30
• United States
  • California
    • Fremont, California, United States, 94538
      • Arcutis Biotherapeutics Clinical Site 19
    • Santa Monica, California, United States, 90404
      • Arcutis Biotherapeutics Clinical Site 21
  • Florida
    • Coral Gables, Florida, United States, 33134
      • Arcutis Biotherapeutics Clinical Site 42
    • Miami, Florida, United States, 33144
      • Arcutis Biotherapeutics Clinical Site 24
    • Tampa, Florida, United States, 33613
      • Arcutis Biotherapeutics Clinical Site 12
  • Illinois
    • Rolling Meadows, Illinois, United States, 60008
      • Arcutis Biotherapeutics Clinical Site 10
  • Indiana
    • Plainfield, Indiana, United States, 46168
      • Arcutis Biotherapeutics Clinical Site 22
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Arcutis Biotherapeutics Clinical Site 15
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Arcutis Biotherapeutics Clinical Site 28
  • Michigan
    • Clinton Township, Michigan, United States, 48038
      • Arcutis Biotherapeutics Clinical Site 40
    • Detroit, Michigan, United States, 48202
      • Arcutis Biotherapeutics Clinical Site 20
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Arcutis Biotherapeutics Clinical Site 14
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Arcutis Biotherapeutics Clinical Site 23
  • Ohio
    • Bexley, Ohio, United States, 43209
      • Arcutis Biotherapeutics Clinical Site 18
  • Oregon
    • Portland, Oregon, United States, 97210
      • Arcutis Biotherapeutics Clinical Site 29
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Arcutis Biotherapeutics Clinical Site 27
  • Texas
    • Arlington, Texas, United States, 76011
      • Arcutis Biotherapeutics Clinical Site 13
    • Austin, Texas, United States, 78759
      • Arcutis Biotherapeutics Clinical Site 11
    • College Station, Texas, United States, 77845
      • Arcutis Biotherapeutics Clinical Site 41
    • Houston, Texas, United States, 77056
      • Arcutis Biotherapeutics Clinical Site 25
    • Pflugerville, Texas, United States, 78660
      • Arcutis Biotherapeutics Clinical Site 26
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Arcutis Biotherapeutics Clinical Site 17

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Roflumilast Foam 0.3%; Participants apply roflumilast foam 0.3% once daily (QD) to all areas of seborrheic dermatitis once daily for 8 weeks.	Drug: Roflumilast Foam 0.3%; Roflumilast foam for topical application.; Other Names: ARQ-154
Placebo Comparator: Vehicle Foam; Participants apply inactive vehicle foam matched to roflumilast foam QD for 8 weeks.	Drug: Vehicle foam; Vehicle foam for topical application.; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Achievement of Investigator Global Assessment (IGA) Success at Week 8	The number of participants achieving "success" in IGA assessment of disease severity at Week 8 is presented for each arm. Success was defined as achievement of an IGA score of 0 ('completely clear') or 1 ('almost clear'), accompanied by a ≥2-grade improvement from baseline IGA score. The IGA is 5-point scale assessing the severity of Seborrheic Dermatitis, with scores ranging from 0 ('completely clear') to 4 ('severe'), and higher scores indicate greater severity. The IGA scores are based on observed data, whereas odds ratio and p-values were calculated using multiple imputation of missing values.	Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Achievement of IGA Success at Weeks 2 and 4	The number of participants achieving "success" in IGA assessment of disease severity at Weeks 2 and 4 is presented for each arm. Success was defined as achievement of an IGA score of 0 ('completely clear') or 1 ('almost clear'), accompanied by a ≥2-grade improvement from baseline IGA score. The IGA is 5-point scale assessing the severity of Seborrheic Dermatitis, with scores ranging from 0 ('completely clear') to 4 ('severe'), and higher scores indicate greater severity. The IGA scores are based on observed data, whereas odds ratio and p-values were calculated using multiple imputation of missing values.	Weeks 2 and 4
Change From Baseline in Overall Assessment of Erythema Score	The mean (SD) change from baseline in Overall Assessment of Erythema score at Weeks 2, 4, and 8 is shown. 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.	Weeks 2, 4, and 8
Achievement of Overall Assessment of Erythema Success	The number of participants achieving "success" in Overall Assessment of Erythema at Weeks 2, 4, and 8 is presented for each arm. Success was defined as achievement of an overall score of 0 or 1 plus a ≥2 grade improvement from Baseline. The Overall Assessment of Erythema 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.	Weeks 2, 4, and 8
Change From Baseline in Overall Assessment of Scaling Score	The mean (SD) change from baseline in Overall Assessment of Scaling score at Weeks 2, 4, and 8 is shown. 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 severity.	Weeks 2, 4, and 8
Achievement of Overall Assessment of Scaling Success	The number of participants achieving "success" in Overall Assessment of Scaling score at Weeks 2, 4, and 8 is presented for each arm. Success was defined as achievement of an Overall Assessment of Scaling score of 0 or 1 plus a ≥2 grade improvement from Baseline. 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 severity.	Weeks 2, 4, and 8
Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score	The change from baseline in WI-NRS is shown. The WI-NRS is a simple, single-item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the subject experienced in the previous 24 hours. Negative values represent a decrease in worst itch from baseline, and positive values indicate an increase.	Weeks 2, 4, and 8
Achievement of WI-NRS Success	The number of participants achieving WI-NRS "success" at Weeks 2, 4, and 8 is presented. Success was defined as achievement of a ≥4-point improvement from baseline WI-NRS score. The WI-NRS is a simple, single-item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the subject experienced in the previous 24 hours.	Weeks 2, 4, and 8

Collaborators and Investigators

• Sponsor: Arcutis Biotherapeutics, Inc.
• Investigators: Study Director: David Berk, MD, Arcutis Biotherapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2019
• Primary Completion (Actual): August 18, 2020
• Study Completion (Actual): August 21, 2020

Study Registration Dates

• First Submitted: September 13, 2019
• First Submitted That Met QC Criteria: September 13, 2019
• First Posted (Actual): September 17, 2019

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Skin Diseases, Eczematous; Sebaceous Gland Diseases; Dermatitis; Dermatitis, Seborrheic
• Other Study ID Numbers: ARQ-154-203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No