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

NCT04845620 | Completed Phase 3 Results FDA Drug

• 1 other identifier: ARQ-151-315
• Study Type: interventional
• Target: 652
• Locations: 2 countries
• Sites: 76

Brief Summary

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).

Conditions

Atopic Dermatitis Eczema

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Achievement of vIGA-AD Success at Week 4 in Participants With 'Moderate' Baseline vIGA-AD

  Week 4

• Achievement of 75% Reduction in the Eczema Area and Severity Index (EASI-75) at Week 4 In Participants With 'Moderate' Baseline vIGA

  Week 4

• Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear'

  Week 4

• Achievement of vIGA-AD Success at Week 2

  Week 2

• Achievement of vIGA-AD Success at Week 1

  Week 1

Study Arms (2)

Roflumilast Cream 0.05%

EXPERIMENTAL

Participants applied roflumilast cream 0.05% qd for 4 weeks.

Drug: Roflumilast Cream 0.05%

Vehicle Cream

PLACEBO COMPARATOR

Participants applied vehicle cream qd for 4 weeks.

Drug: Vehicle Cream

Interventions

Roflumilast Cream 0.05% DRUG

Roflumilast cream for topical application.

Also known as: ARQ-151

Roflumilast Cream 0.05%

Vehicle Cream DRUG

Vehicle cream matched to roflumilast cream for topical application.

Vehicle Cream

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Informed consent by parent(s) or legal guardian as required by local laws.
• Males and females, ages 2 to 5 years old at time of signing Informed Consent (Screening) and at Baseline (Day 1).
• 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.
• In good health as judged by the Investigator.
• Subjects considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.

You may not qualify if:

• 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
• Has unstable AD or any consistent requirement for high potency topical steroids.
• Subjects who are unwilling to refrain from prolonged sun exposure for 4 weeks prior to Baseline/Day 1 and during the study.
• Previous treatment with ARQ-151.
• 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.
• 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.

Sponsors & Collaborators

• Arcutis Biotherapeutics, Inc.: lead

Study Sites (76)

Arcutis Clinical Site 56

Birmingham, Alabama, 35209, United States

Location

Arcutis Clinical Site 14

Birmingham, Alabama, 35244, United States

Location

Arcutis Clinical Site 69

Montgomery, Alabama, 36117, United States

Location

Arcutis Clinical Site 68

Gilbert, Arizona, 85234, United States

Location

Arcutis Clinical Site 26

Scottsdale, Arizona, 85255, United States

Location

Arcutis Clinical Site 50

Bryant, Arkansas, 72022, United States

Location

Arcutis Clinical Site 59

Fort Smith, Arkansas, 72916, United States

Location

Arcutis Clinical Site 71

Little Rock, Arkansas, 72212, United States

Location

Arcutis Clinical Site 09

Inglewood, California, 90301, United States

Location

Arcutis Clinical Site 45

Rancho Santa Margarita, California, 92688, United States

Location

Arcutis Clinical Site 30

San Diego, California, 92123, United States

Location

Arcutis Clinical Site 70

Thousand Oaks, California, 91320, United States

Location

Arcutis Clinical Site 48

Boca Raton, Florida, 33486, United States

Location

Arcutis Clinical Site 33

Coral Gables, Florida, 33134, United States

Location

Arcutis Clinical Site 12

Coral Gables, Florida, 33146, United States

Location

Arcutis Clinical Site 11

Delray Beach, Florida, 33484, United States

Location

Arcutis Clinical Site 28

Largo, Florida, 33770, United States

Location

Arcutis Clinical Site 79

Miami, Florida, 33137, United States

Location

Arcutis Clinical Site 43

Miami, Florida, 33173, United States

Location

Arcutis Clinical Site 10

Miami Lakes, Florida, 33014, United States

Location

Arcutis Clinical Site 35

North Miami Beach, Florida, 33162, United States

Location

Arcutis Clinical Site 75

Wellington, Florida, 33449, United States

Location

Arcutis Clinical Site 20

Sandy Springs, Georgia, 30328, United States

Location

Arcutis Clinical Site 82

Boise, Idaho, 83706, United States

Location

Arcutis Clinical Site 60

Chicago, Illinois, 60607, United States

Location

Arcutis Clinical Site 07

Rolling Meadows, Illinois, 33770, United States

Location

Arcutis Clinical Site 42

Clarksville, Indiana, 47129, United States

Location

Arcutis Clinical Site 21

Plainfield, Indiana, 46168, United States

Location

Arcutis Clinical Site 57

West Lafayette, Indiana, 47906, United States

Location

Arcutis Clinical Site 22

Louisville, Kentucky, 40217, United States

Location

Arcutis Clinical Site 46

Louisville, Kentucky, 40241, United States

Location

Arcutis Clinical Site 84

Baton Rouge, Louisiana, 70808, United States

Location

Arcutis Clinical Site 34

Lake Charles, Louisiana, 70605, United States

Location

Arcutis Clinical Site 51

Metairie, Louisiana, 70005, United States

Location

Arcutis Clinical Site 40

Metairie, Louisiana, 70006, United States

Location

Arcutis Clinical Site 77

Columbia, Maryland, 21045, United States

Location

Arcutis Clinical Site 13

Rockville, Maryland, 20850, United States

Location

Arcutis Clinical Site 15

Rockville, Maryland, 20850, United States

Location

Arcutis Clinical Site 53

Auburn Hills, Michigan, 48326, United States

Location

Arcutis Clinical Site 41

Bay City, Michigan, 48706, United States

Location

Arcutis Clinical Site 36

Clarkston, Michigan, 48346, United States

Location

Arcutis Clinical Site 72

Troy, Michigan, 48084, United States

Location

Arcutis Clinical Site 05

New Brighton, Minnesota, 55112, United States

Location

Arcutis Clinical Site 47

Saint Joseph, Missouri, 64506, United States

Location

Arcutis Clinical Site 16

Reno, Nevada, 89509, United States

Location

Arcutis Clinical Site 55

Lebanon, New Hampshire, 03756, United States

Location

Arcutis Clinical Site 54

Brooklyn, New York, 11203, United States

Location

Arcutis Clinical Site 44

New York, New York, 11415, United States

Location

Arcutis Clinical Site 32

Rochester, New York, 14623, United States

Location

Arcutis Clinical Site 58

Cincinnati, Ohio, 45229, United States

Location

Arcutis Clinical Site 81

Mason, Ohio, 45040, United States

Location

Arcutis Clinical Site 01

Gresham, Oregon, 97030, United States

Location

Arcutis Clinical Site 52

Portland, Oregon, 97210, United States

Location

Arcutis Clinical Site 63

Portland, Oregon, 97239, United States

Location

Arcutis Clinical Site 65

Bethlehem, Pennsylvania, 18105, United States

Location

Arcutis Clinical Site 31

Hershey, Pennsylvania, 17033, United States

Location

Arcutis Clinical Site 24

Newtown Square, Pennsylvania, 19073, United States

Location

Arcutis Clinical Site 62

Charleston, South Carolina, 29425, United States

Location

Arcutis Clinical Site 39

Summerville, South Carolina, 29486, United States

Location

Arcutis Clinical Site 08

Austin, Texas, 78759, United States

Location

Arcutis Clinical Site 27

Bellaire, Texas, 77401, United States

Location

Arcutis Clinical Site 74

Fort Worth, Texas, 76244, United States

Location

Arcutis Clinical Site 66

Frisco, Texas, 75034, United States

Location

Arcutis Clinical Site 61

Grapevine, Texas, 76051, United States

Location

Arcutis Clinical Site 04

Houston, Texas, 77030, United States

Location

Arcutis Clinical Site 02

San Antonio, Texas, 78213, United States

Location

Arcutis Clinical Site 18

San Antonio, Texas, 78218, United States

Location

Arcutis Clinical Site 03

South Jordan, Utah, 84095, United States

Location

Arcutis Clinical Site 06

Burke, Virginia, 22015, United States

Location

Arcutis Clinical Site 76

Charlottesville, Virginia, 22902, United States

Location

Arcutis Clinical Site 25

Spokane, Washington, 99202, United States

Location

Arcutis Clinical Site 29

Calgary, Alberta, T2J 7E1, Canada

Location

Arcutis Clinical Site 64

Winnipeg, Manitoba, R3C 0N2, Canada

Location

Arcutis Clinical Site 73

Burlington, Ontario, L7L 6W6, Canada

Location

Arcutis Clinical Site 36

Markham, Ontario, L3P 1X3, Canada

Location

Arcutis Clinical Site 78

Saskatoon, Saskatchewan, S7K 2C1, Canada

Location

Related Publications (2)

• Eichenfield LF, Gonzalez ME, Boguniewicz M, Funk T, Hebert AA, Prajapati VH, Kindred C, Serrao R, Swanson L, Krupa D, Snyder S, Seal MS, Hanna D, Burnett P, Berk DR. Long-Term Safety and Efficacy of Once-Daily and Proactive Twice-Weekly Roflumilast Cream 0.05% for Mild-to-Moderate Atopic Dermatitis in Children Aged 2-5 Years From a 52-Week, Phase 3 Trial (INTEGUMENT-OLE). Pediatr Dermatol. 2026 Mar 8. doi: 10.1111/pde.70177. Online ahead of print.

  PMID: 41795905 DERIVED

• 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.

  PMID: 39980188 DERIVED

Results Point of Contact

• Title: Arcutis Medical Information
• Organization: Arcutis Biotherapeutics

medinfo@arcutis.com

+1 (844) 692-6729

Study Officials

• David Berk, MD

  Arcutis Biotherapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2021
• First Posted: April 15, 2021
• Study Start: April 7, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: December 23, 2025
• Results First Posted: December 23, 2025

Record last verified: 2025-12

Locations

US (71); CA (5)