Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED)

A Phase 3, 4-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.05% Administered QD in Subjects With Atopic Dermatitis

This was a Phase 3, 4-week, double-blind study to assess the safety and efficacy of ARQ-151 cream compared to vehicle cream applied once daily (qd) for 4 weeks in children 2 to 5 years of age with atopic dermatitis (AD).

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis Eczema
• Intervention / Treatment: Drug: Roflumilast Cream 0.05%; Drug: Vehicle Cream

Detailed Description

This is a parallel group, double blind, vehicle-controlled study in which ARQ-151 cream or vehicle is applied once daily for 4 weeks to subjects with atopic dermatitis.

• Study Type: Interventional
• Enrollment (Actual): 652
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2J 7E1
      • Arcutis Clinical Site 29
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3C 0N2
      • Arcutis Clinical Site 64
  • Ontario
    • Burlington, Ontario, Canada, L7L 6W6
      • Arcutis Clinical Site 73
    • Markham, Ontario, Canada, L3P 1X3
      • Arcutis Clinical Site 36
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7K 2C1
      • Arcutis Clinical Site 78
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Arcutis Clinical Site 56
    • Birmingham, Alabama, United States, 35244
      • Arcutis Clinical Site 14
    • Montgomery, Alabama, United States, 36117
      • Arcutis Clinical Site 69
  • Arizona
    • Gilbert, Arizona, United States, 85234
      • Arcutis Clinical Site 68
    • Scottsdale, Arizona, United States, 85255
      • Arcutis Clinical Site 26
  • Arkansas
    • Bryant, Arkansas, United States, 72022
      • Arcutis Clinical Site 50
    • Fort Smith, Arkansas, United States, 72916
      • Arcutis Clinical Site 59
    • Little Rock, Arkansas, United States, 72212
      • Arcutis Clinical Site 71
  • California
    • Inglewood, California, United States, 90301
      • Arcutis Clinical Site 09
    • Rancho Santa Margarita, California, United States, 92688
      • Arcutis Clinical Site 45
    • San Diego, California, United States, 92123
      • Arcutis Clinical Site 30
    • Thousand Oaks, California, United States, 91320
      • Arcutis Clinical Site 70
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Arcutis Clinical Site 48
    • Coral Gables, Florida, United States, 33134
      • Arcutis Clinical Site 33
    • Coral Gables, Florida, United States, 33146
      • Arcutis Clinical Site 12
    • Delray Beach, Florida, United States, 33484
      • Arcutis Clinical Site 11
    • Largo, Florida, United States, 33770
      • Arcutis Clinical Site 28
    • Miami, Florida, United States, 33137
      • Arcutis Clinical Site 79
    • Miami, Florida, United States, 33173
      • Arcutis Clinical Site 43
    • Miami Lakes, Florida, United States, 33014
      • Arcutis Clinical Site 10
    • North Miami Beach, Florida, United States, 33162
      • Arcutis Clinical Site 35
    • Wellington, Florida, United States, 33449
      • Arcutis Clinical Site 75
  • Georgia
    • Sandy Springs, Georgia, United States, 30328
      • Arcutis Clinical Site 20
  • Idaho
    • Boise, Idaho, United States, 83706
      • Arcutis Clinical Site 82
  • Illinois
    • Chicago, Illinois, United States, 60607
      • Arcutis Clinical Site 60
    • Rolling Meadows, Illinois, United States, 33770
      • Arcutis Clinical Site 07
  • Indiana
    • Clarksville, Indiana, United States, 47129
      • Arcutis Clinical Site 42
    • Plainfield, Indiana, United States, 46168
      • Arcutis Clinical Site 21
    • West Lafayette, Indiana, United States, 47906
      • Arcutis Clinical Site 57
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Arcutis Clinical Site 22
    • Louisville, Kentucky, United States, 40241
      • Arcutis Clinical Site 46
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Arcutis Clinical Site 84
    • Lake Charles, Louisiana, United States, 70605
      • Arcutis Clinical Site 34
    • Metairie, Louisiana, United States, 70005
      • Arcutis Clinical Site 51
    • Metairie, Louisiana, United States, 70006
      • Arcutis Clinical Site 40
  • Maryland
    • Columbia, Maryland, United States, 21045
      • Arcutis Clinical Site 77
    • Rockville, Maryland, United States, 20850
      • Arcutis Clinical Site 13
    • Rockville, Maryland, United States, 20850
      • Arcutis Clinical Site 15
  • Michigan
    • Auburn Hills, Michigan, United States, 48326
      • Arcutis Clinical Site 53
    • Bay City, Michigan, United States, 48706
      • Arcutis Clinical Site 41
    • Clarkston, Michigan, United States, 48346
      • Arcutis Clinical Site 36
    • Troy, Michigan, United States, 48084
      • Arcutis Clinical Site 72
  • Minnesota
    • New Brighton, Minnesota, United States, 55112
      • Arcutis Clinical Site 05
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • Arcutis Clinical Site 47
  • Nevada
    • Reno, Nevada, United States, 89509
      • Arcutis Clinical Site 16
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Arcutis Clinical Site 55
  • New York
    • Brooklyn, New York, United States, 11203
      • Arcutis Clinical Site 54
    • New York, New York, United States, 11415
      • Arcutis Clinical Site 44
    • Rochester, New York, United States, 14623
      • Arcutis Clinical Site 32
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Arcutis Clinical Site 58
    • Mason, Ohio, United States, 45040
      • Arcutis Clinical Site 81
  • Oregon
    • Gresham, Oregon, United States, 97030
      • Arcutis Clinical Site 01
    • Portland, Oregon, United States, 97210
      • Arcutis Clinical Site 52
    • Portland, Oregon, United States, 97239
      • Arcutis Clinical Site 63
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18105
      • Arcutis Clinical Site 65
    • Hershey, Pennsylvania, United States, 17033
      • Arcutis Clinical Site 31
    • Newtown Square, Pennsylvania, United States, 19073
      • Arcutis Clinical Site 24
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Arcutis Clinical Site 62
    • Summerville, South Carolina, United States, 29486
      • Arcutis Clinical Site 39
  • Texas
    • Austin, Texas, United States, 78759
      • Arcutis Clinical Site 08
    • Bellaire, Texas, United States, 77401
      • Arcutis Clinical Site 27
    • Fort Worth, Texas, United States, 76244
      • Arcutis Clinical Site 74
    • Frisco, Texas, United States, 75034
      • Arcutis Clinical Site 66
    • Grapevine, Texas, United States, 76051
      • Arcutis Clinical Site 61
    • Houston, Texas, United States, 77030
      • Arcutis Clinical Site 04
    • San Antonio, Texas, United States, 78213
      • Arcutis Clinical Site 02
    • San Antonio, Texas, United States, 78218
      • Arcutis Clinical Site 18
  • Utah
    • South Jordan, Utah, United States, 84095
      • Arcutis Clinical Site 03
  • Virginia
    • Burke, Virginia, United States, 22015
      • Arcutis Clinical Site 06
    • Charlottesville, Virginia, United States, 22902
      • Arcutis Clinical Site 76
  • Washington
    • Spokane, Washington, United States, 99202
      • Arcutis Clinical Site 25

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Informed consent by parent(s) or legal guardian as required by local laws.
2. Males and females, ages 2 to 5 years old at time of signing Informed Consent (Screening) and at Baseline (Day 1).
3. Diagnosed with atopic dermatitis for at least 6 weeks, as determined by the Investigator. Stable disease for the past 4 weeks with no significant flares in atopic dermatitis before screening.
4. In good health as judged by the Investigator.
5. Subjects considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.

Exclusion Criteria:

1. 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
2. Has unstable AD or any consistent requirement for high potency topical steroids.
3. Subjects who are unwilling to refrain from prolonged sun exposure for 4 weeks prior to Baseline/Day 1 and during the study.
4. Previous treatment with ARQ-151.
5. Parent(s)/legal guardian(s) who are unable to communicate, read, or understand the local language(s). 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.
6. Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled (in other studies of ARQ-151) subjects living in the same house.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Roflumilast Cream 0.05%; Participants applied roflumilast cream 0.05% qd for 4 weeks.	Drug: Roflumilast Cream 0.05%; Roflumilast cream for topical application.; Other Names: ARQ-151
Placebo Comparator: Vehicle Cream; Participants applied vehicle cream qd for 4 weeks.	Drug: Vehicle Cream; Vehicle cream matched to roflumilast cream for topical application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Achievement of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Success at Week 4	The percentage of participants with vIGA-AD success at Week 4 is presented. The vIGA-AD is a static evaluation of qualitative overall AD severity with five severity grades (reported as score of 0 'clear' to 4 'severe' with higher scores indicating greater symptom severity. vIGA success was defined as score of 'clear' or 'almost clear' plus a 2-grade improvement from baseline.	Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Achievement of vIGA-AD Success at Week 4 in Participants With 'Moderate' Baseline vIGA-AD	The percentage of participants with vIGA-AD success at Week 4 who had 'moderate' vIGA-AD score (vIGA score of 3) at baseline is presented. The vIGA-AD is a static evaluation of qualitative overall AD severity with five severity grades (reported as score of 0 'clear' to 4 'severe' with higher scores indicating greater symptom severity. vIGA-AD success was defined as score of 'clear' or 'almost clear' plus a 2-grade improvement from baseline in participants with moderate vIGA-AD baseline.	Week 4
Achievement of 75% Reduction in the Eczema Area and Severity Index (EASI-75) at Week 4 In Participants With 'Moderate' Baseline vIGA	The percentage of participants with a moderate baseline vIGA-AD score who achieved EASI-75 is presented. EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head {10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI.	Week 4
Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear'	The percentage of participants with vIGA-AD score of 'clear' or 'almost clear' at Week 4 is presented. The vIGA is a static evaluation of qualitative overall AD severity with five severity grades (reported as score of 0 'clear' to 4 'severe' with higher scores indicating greater symptom severity.	Week 4
Achievement of vIGA-AD Success at Week 2	The percentage of participants with vIGA-AD success at Week 2 is presented. The vIGA-AD is a static evaluation of qualitative overall AD severity with five severity grades (reported as score of 0 'clear' to 4 'severe' with higher scores indicating greater symptom severity. vIGA success was defined as score of 'clear' or 'almost clear' plus a 2-grade improvement from baseline.	Week 2
Achievement of vIGA-AD Success at Week 1	The percentage of participants with vIGA-AD success at Week 1 is presented. The vIGA-AD is a static evaluation of qualitative overall AD severity with five severity grades (reported as score of 0 'clear' to 4 'severe' with higher scores indicating greater symptom severity. vIGA-AD success was defined as score of 'clear' or 'almost clear' plus a 2-grade improvement from baseline.	Week 1
Achievement of vIGA-AD of 'Clear' or 'Almost Clear' at Week 2	The percentage of participants with vIGA-AD score of 'clear' or 'almost clear' at Week 2 is presented. The vIGA-AD is a static evaluation of qualitative overall AD severity with five severity grades (reported as score of 0 'clear' to 4 'severe' with higher scores indicating greater symptom severity.	Week 2
Achievement of vIGA-AD of 'Clear' or 'Almost Clear' at Week 1	The percentage of participants with vIGA-AD score of 'clear' or 'almost clear' at Week 1 is presented. The vIGA-AD is a static evaluation of qualitative overall AD severity with five severity grades (reported as score of 0 'clear' to 4 'severe' with higher scores indicating greater symptom severity.	Week 1

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Eichenfield LF, Serrao R, Prajapati VH, Browning JC, Swanson L, Funk T, Gonzalez ME, Hebert AA, Lee M, Boguniewicz M, Simpson EL, Seal MS, Krupa D, Hanna D, Snyder S, Burnett P, Chu DH, Almaraz E, Higham RC, Berk DR. Efficacy and Safety of Once-Daily Roflumilast Cream 0.05% in Pediatric Patients Aged 2-5 Years With Mild-to-Moderate Atopic Dermatitis (INTEGUMENT-PED): A Phase 3 Randomized Controlled Trial. Pediatr Dermatol. 2025 Mar-Apr;42(2):296-304. doi: 10.1111/pde.15840. Epub 2025 Feb 20.

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2021
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: April 11, 2021
• First Submitted That Met QC Criteria: April 11, 2021
• First Posted (Actual): April 15, 2021

Study Record Updates

• Last Update Posted (Estimated): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: ARQ-151-315

Drug and device information, study documents

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