Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED)
NCT ID: NCT04845620
Last Updated: 2025-12-23
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
652 participants
INTERVENTIONAL
2021-04-07
2023-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Roflumilast Cream 0.05%
Participants applied roflumilast cream 0.05% qd for 4 weeks.
Roflumilast Cream 0.05%
Roflumilast cream for topical application.
Vehicle Cream
Participants applied vehicle cream qd for 4 weeks.
Vehicle Cream
Vehicle cream matched to roflumilast cream for topical application.
Interventions
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Roflumilast Cream 0.05%
Roflumilast cream for topical application.
Vehicle Cream
Vehicle cream matched to roflumilast cream for topical application.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
2 Years
5 Years
ALL
No
Sponsors
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Arcutis Biotherapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David Berk, MD
Role: STUDY_DIRECTOR
Arcutis Biotherapeutics, Inc.
Locations
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Arcutis Clinical Site 56
Birmingham, Alabama, United States
Arcutis Clinical Site 14
Birmingham, Alabama, United States
Arcutis Clinical Site 69
Montgomery, Alabama, United States
Arcutis Clinical Site 68
Gilbert, Arizona, United States
Arcutis Clinical Site 26
Scottsdale, Arizona, United States
Arcutis Clinical Site 50
Bryant, Arkansas, United States
Arcutis Clinical Site 59
Fort Smith, Arkansas, United States
Arcutis Clinical Site 71
Little Rock, Arkansas, United States
Arcutis Clinical Site 09
Inglewood, California, United States
Arcutis Clinical Site 45
Rancho Santa Margarita, California, United States
Arcutis Clinical Site 30
San Diego, California, United States
Arcutis Clinical Site 70
Thousand Oaks, California, United States
Arcutis Clinical Site 48
Boca Raton, Florida, United States
Arcutis Clinical Site 33
Coral Gables, Florida, United States
Arcutis Clinical Site 12
Coral Gables, Florida, United States
Arcutis Clinical Site 11
Delray Beach, Florida, United States
Arcutis Clinical Site 28
Largo, Florida, United States
Arcutis Clinical Site 79
Miami, Florida, United States
Arcutis Clinical Site 43
Miami, Florida, United States
Arcutis Clinical Site 10
Miami Lakes, Florida, United States
Arcutis Clinical Site 35
North Miami Beach, Florida, United States
Arcutis Clinical Site 75
Wellington, Florida, United States
Arcutis Clinical Site 20
Sandy Springs, Georgia, United States
Arcutis Clinical Site 82
Boise, Idaho, United States
Arcutis Clinical Site 60
Chicago, Illinois, United States
Arcutis Clinical Site 07
Rolling Meadows, Illinois, United States
Arcutis Clinical Site 42
Clarksville, Indiana, United States
Arcutis Clinical Site 21
Plainfield, Indiana, United States
Arcutis Clinical Site 57
West Lafayette, Indiana, United States
Arcutis Clinical Site 22
Louisville, Kentucky, United States
Arcutis Clinical Site 46
Louisville, Kentucky, United States
Arcutis Clinical Site 84
Baton Rouge, Louisiana, United States
Arcutis Clinical Site 34
Lake Charles, Louisiana, United States
Arcutis Clinical Site 51
Metairie, Louisiana, United States
Arcutis Clinical Site 40
Metairie, Louisiana, United States
Arcutis Clinical Site 77
Columbia, Maryland, United States
Arcutis Clinical Site 13
Rockville, Maryland, United States
Arcutis Clinical Site 15
Rockville, Maryland, United States
Arcutis Clinical Site 53
Auburn Hills, Michigan, United States
Arcutis Clinical Site 41
Bay City, Michigan, United States
Arcutis Clinical Site 36
Clarkston, Michigan, United States
Arcutis Clinical Site 72
Troy, Michigan, United States
Arcutis Clinical Site 05
New Brighton, Minnesota, United States
Arcutis Clinical Site 47
Saint Joseph, Missouri, United States
Arcutis Clinical Site 16
Reno, Nevada, United States
Arcutis Clinical Site 55
Lebanon, New Hampshire, United States
Arcutis Clinical Site 54
Brooklyn, New York, United States
Arcutis Clinical Site 44
New York, New York, United States
Arcutis Clinical Site 32
Rochester, New York, United States
Arcutis Clinical Site 58
Cincinnati, Ohio, United States
Arcutis Clinical Site 81
Mason, Ohio, United States
Arcutis Clinical Site 01
Gresham, Oregon, United States
Arcutis Clinical Site 52
Portland, Oregon, United States
Arcutis Clinical Site 63
Portland, Oregon, United States
Arcutis Clinical Site 65
Bethlehem, Pennsylvania, United States
Arcutis Clinical Site 31
Hershey, Pennsylvania, United States
Arcutis Clinical Site 24
Newtown Square, Pennsylvania, United States
Arcutis Clinical Site 62
Charleston, South Carolina, United States
Arcutis Clinical Site 39
Summerville, South Carolina, United States
Arcutis Clinical Site 08
Austin, Texas, United States
Arcutis Clinical Site 27
Bellaire, Texas, United States
Arcutis Clinical Site 74
Fort Worth, Texas, United States
Arcutis Clinical Site 66
Frisco, Texas, United States
Arcutis Clinical Site 61
Grapevine, Texas, United States
Arcutis Clinical Site 04
Houston, Texas, United States
Arcutis Clinical Site 02
San Antonio, Texas, United States
Arcutis Clinical Site 18
San Antonio, Texas, United States
Arcutis Clinical Site 03
South Jordan, Utah, United States
Arcutis Clinical Site 06
Burke, Virginia, United States
Arcutis Clinical Site 76
Charlottesville, Virginia, United States
Arcutis Clinical Site 25
Spokane, Washington, United States
Arcutis Clinical Site 29
Calgary, Alberta, Canada
Arcutis Clinical Site 64
Winnipeg, Manitoba, Canada
Arcutis Clinical Site 73
Burlington, Ontario, Canada
Arcutis Clinical Site 36
Markham, Ontario, Canada
Arcutis Clinical Site 78
Saskatoon, Saskatchewan, Canada
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ARQ-151-315
Identifier Type: -
Identifier Source: org_study_id