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

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

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.

Study Overview

• Status: Completed
• Conditions: Seborrheic Dermatitis
• Intervention / Treatment: Drug: Roflumilast Foam; 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 for 8 weeks to subjects with seborrheic dermatitis.

• Study Type: Interventional
• Enrollment (Actual): 457
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2J 7E1
      • Arcutis Biotherapeutics Clinical Site 35
  • British Columbia
    • Surrey, British Columbia, Canada, V3V 0C6
      • Arcutis Biotherapeutics Clinical Site 37
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M 3Z4
      • Arcutis Biotherapeutics Clinical Site 47
  • New Brunswick
    • Fredericton, New Brunswick, Canada, E3B 1G9
      • Arcutis Biotherapeutics Clinical Site 43
  • Ontario
    • London, Ontario, Canada, N6H 5L5
      • Arcutis Biotherapeutics Clinical Site 16
    • Mississauga, Ontario, Canada, L5H 1G9
      • Arcutis Biotherapeutics Clinical Site 29
    • North Bay, Ontario, Canada, P1B 3Z7
      • Arcutis Biotherapeutics Clinical Site 30
    • Peterborough, Ontario, Canada, K9J 5K2
      • Arcutis Biotherapeutics Clinical Site 32
    • Waterloo, Ontario, Canada, N2J 1C4
      • Arcutis Biotherapeutics Clinical Site 36
  • Quebec
    • Westmount, Quebec, Canada, H3Z 2S6
      • Arcutis Biotherapeutics Clinical Site 09
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85255
      • Arcutis Biotherapeutics Clinical Site 01
  • California
    • Encinitas, California, United States, 92024
      • Arcutis Biotherapeutics Clinical Site 45
    • San Diego, California, United States, 92123
      • Arcutis Biotherapeutics Clinical Site 64
    • San Diego, California, United States, 92123
      • Arcutis Biotherapeutics Clinical Site 46
    • Santa Monica, California, United States, 90404
      • Arcutis Biotherapeutics Clinical Site 21
  • Florida
    • Coral Gables, Florida, United States, 33134
      • Arcutis Biotherapeutics Clinical Site 42
    • Delray Beach, Florida, United States, 33484
      • Arcutis Biotherapeutics Clinical Site 57
    • Largo, Florida, United States, 33770
      • Arcutis Biotherapeutics Clinical Site 33
    • North Miami Beach, Florida, United States, 33162
      • Arcutis Biotherapeutics Clinical Site 31
    • Sanford, Florida, United States, 32771
      • Arcutis Biotherapeutics Clinical Site 65
    • Tampa, Florida, United States, 33613
      • Arcutis Biotherapeutics Clinical Site 12
  • Illinois
    • Rolling Meadows, Illinois, United States, 60008
      • Arcutis Biotherapeutics Clinical Site 10
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Arcutis Biotherapeutics Clinical Site 03
    • Plainfield, Indiana, United States, 46168
      • Arcutis Biotherapeutics Clinical Site 22
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Arcutis Biotherapeutics Clinical Site 15
  • Louisiana
    • Lake Charles, Louisiana, United States, 70605
      • Arcutis Biotherapeutics Clinical Site 04
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Arcutis Biotherapeutics Clinical Site 02
    • 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
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • Arcutis Biotherapeutics Clinical Site 44
  • Nevada
    • Reno, Nevada, United States, 89509
      • Arcutis Biotherapeutics Clinical Site 19
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Arcutis Biotherapeutics Clinical Site 34
  • New York
    • Bronx, New York, United States, 10462
      • Arcutis Biotherapeutics Clinical Site 63
    • New York, New York, United States, 10065
      • Arcutis Biotherapeutics Clinical Site 66
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Arcutis Biotherapeutics Clinical Site 23
    • Winston-Salem, North Carolina, United States, 27104
      • Arcutis Biotherapeutics Clinical Site 70
  • Ohio
    • Bexley, Ohio, United States, 43209
      • Arcutis Biotherapeutics Clinical Site 18
  • Oregon
    • Portland, Oregon, United States, 97223
      • Arcutis Biotherapeutics Clinical Site 71
  • Pennsylvania
    • Broomall, Pennsylvania, United States, 19008
      • Arcutis Biotherapeutics Clinical Site 08
    • Pittsburgh, Pennsylvania, United States, 15213
      • Arcutis Biotherapeutics Clinical Site 27
  • Tennessee
    • Knoxville, Tennessee, United States, 37922
      • Arcutis Biotherapeutics Clinical Site 06
  • 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, 77030
      • Arcutis Biotherapeutics Clinical Site 60
    • Pflugerville, Texas, United States, 78660
      • Arcutis Biotherapeutics Clinical Site 26
    • Plano, Texas, United States, 75024
      • Arcutis Biotherapeutics Clinical Site 72
    • San Antonio, Texas, United States, 78213
      • Arcutis Biotherapeutics Clinical Site 54
    • San Antonio, Texas, United States, 78218
      • Arcutis Biotherapeutics Clinical Site 24
  • Utah
    • West Jordan, Utah, United States, 84088
      • Arcutis Biotherapeutics Clinical Site 07
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Arcutis Biotherapeutics Clinical Site 17

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

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
Experimental: Roflumilast Foam 0.3%; Participants with seborrheic dermatitis apply roflumilast foam 0.3% once daily (QD) for 8 weeks.	Drug: Roflumilast Foam; Roflumilast 0.3% foam for topical application; Other Names: ARQ-154
Placebo Comparator: Vehicle Foam; Participants with seborrheic dermatitis apply vehicle foam QD for 8 weeks.	Drug: Vehicle Foam; Vehicle foam for topical application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Achievement of Success on the Investigator Global Assessment (IGA) at 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].	Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Achievement of Success in the Worst Itch Numeric Rating Scale (WI-NRS) at 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.	Week 8
Achievement of Success in the WI-NRS at 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.	Week 4
Achievement of Success in the WI-NRS at 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).	Week 2
Achievement of Success on the IGA at 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.	Week 2
Achievement of Success on the IGA at 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].	Week 4
Achievement of Overall Assessment of Scaling Score of 0 at 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.	Week 8
Achievement of Overall Assessment of Erythema Score of 0 at 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.	Week 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): July 8, 2021
• Primary Completion (Actual): April 6, 2022
• Study Completion (Actual): April 6, 2022

Study Registration Dates

• First Submitted: July 13, 2021
• First Submitted That Met QC Criteria: July 13, 2021
• First Posted (Actual): July 22, 2021

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

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-154-304

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