Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis
NCT ID: NCT04773587
Last Updated: 2024-10-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
654 participants
INTERVENTIONAL
2021-01-27
2022-08-30
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 0.15%
Participants with mild to moderate AD apply roflumilast cream 0.15% QD for 4 weeks.
Roflumilast Cream 0.15%
Roflumilast Cream 0.15% - Active
Vehicle Cream
Participants with mild to moderate AD applied vehicle cream QD for 4 weeks.
Vehicle Cream
Cream - Vehicle
Interventions
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Roflumilast Cream 0.15%
Roflumilast Cream 0.15% - Active
Vehicle Cream
Cream - Vehicle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Males and females, ages 6 years and older at time of signing Informed Consent (Screening). Only subjects 18 years and older will be enrolled at sites located in the province of Québec in Canada.
3. Diagnosed with atopic dermatitis 6 months duration (3 months for children), as determined by the Investigator. Stable disease for the past 4 weeks with no significant flares in atopic dermatitis before screening.
4. Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline/Day 1. In addition, sexually active FOCBP must agree to use at least one form of a highly effective or barrier method of contraception throughout the trial.
5. In good health as judged by the Investigator.
6. 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 and from using a tanning bed or other artificial light emitting devices (LEDs) for 4 weeks prior to Baseline/Day 1 and during the study.
4. Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
5. Previous treatment with ARQ-151.
6. Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Screening.
7. 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.
8. Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled subjects living in the same house.
6 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 57
Montgomery, Alabama, United States
Arcutis Clinical Site 34
Scottsdale, Arizona, United States
Arcutis Clinical Site 58
Little Rock, Arkansas, United States
Arcutis Clinical Site 40
Beverly Hills, California, United States
Arcutis Clinical Site 06
Encinitas, California, United States
Arcutis Clinical Site 52
Los Angeles, California, United States
Arcutis Clinical Site 05
San Diego, California, United States
Arcutis Clinical Site 08
San Francisco, California, United States
Arcutis Clinical Site 62
Thousand Oaks, California, United States
Arcutis Clinical Site 30
Coral Gables, Florida, United States
Arcutis Clinical Site 04
Jacksonville, Florida, United States
Arcutis Clinical Site 15
Largo, Florida, United States
Arcutis Clinical Site 39
Miami Lakes, Florida, United States
Arcutis Clinical Site 38
North Miami Beach, Florida, United States
Arcutis Clinical Site 01
Tampa, Florida, United States
Arcutis Clinical Site 61
Wellington, Florida, United States
Arcutis Clinical Site 26
Sandy Springs, Georgia, United States
Arcutis Clinical Site 13
Rolling Meadows, Illinois, United States
Arcutis Clinical Site 48
Clarksville, Indiana, United States
Arcutis Clinical Site 02
Indianapolis, Indiana, United States
Arcutis Clinical Site 03
Louisville, Kentucky, United States
Arcutis Clinical Site 36
Rockville, Maryland, United States
Arcutis Clinical Site 55
Auburn Hills, Michigan, United States
Arcutis Clinical Site 54
Bay City, Michigan, United States
Arcutis Clinical Site 46
Clarkston, Michigan, United States
Arcutis Clinical Site 37
Detroit, Michigan, United States
Arcutis Clinical Site 10
New Brighton, Minnesota, United States
Arcutis Clinical Site 33
Reno, Nevada, United States
Arcutis Clinical Site 42
East Windsor, New Jersey, United States
Arcutis Clinical Site 17
Gresham, Oregon, United States
Arcutis Clinical Site 16
Portland, Oregon, United States
Arcutis Clinical Site 14
Portland, Oregon, United States
Arcutis Clinical Site 35
Newtown Square, Pennsylvania, United States
Arcutis Clinical Site 101
Johnston, Rhode Island, United States
Arcutis Clinical Site 31
Murfreesboro, Tennessee, United States
Arcutis Clinical Site 19
Arlington, Texas, United States
Arcutis Clinical Site 43
Bellaire, Texas, United States
Arcutis Clinical Site 27
Houston, Texas, United States
Arcutis Clinical Site 20
Houston, Texas, United States
Arcutis Clinical Site 28
San Antonio, Texas, United States
Arcutis Clinical Site 21
South Jordan, Utah, United States
Arcutis Clinical Site 12
Spokane, Washington, United States
Arcutis Clinical Site 41
Calgary, Alberta, Canada
Arcutis Clinical Site 29
Fredericton, New Brunswick, Canada
Arcutis Clinical Site 11
Markham, Ontario, Canada
Clinical Site 25
Mississauga, Ontario, Canada
Arcutis Clinical Site 32
Peterborough, Ontario, Canada
Arcutis Clinical Site 09
Windsor, Ontario, Canada
Arcutis Clinical Site 24
Montreal, Quebec, Canada
Countries
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References
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Simpson EL, Eichenfield LF, Alonso-Llamazares J, Draelos ZD, Ferris LK, Forman SB, Gooderham M, Gonzalez ME, Hebert AA, Kircik LH, Lomaga M, Moore A, Papp KA, Prajapati VH, Hanna D, Snyder S, Krupa D, Burnett P, Almaraz E, Higham RC, Chu DH, Berk DR. Roflumilast Cream, 0.15%, for Atopic Dermatitis in Adults and Children: INTEGUMENT-1 and INTEGUMENT-2 Randomized Clinical Trials. JAMA Dermatol. 2024 Nov 1;160(11):1161-1170. doi: 10.1001/jamadermatol.2024.3121.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ARQ-151-311
Identifier Type: -
Identifier Source: org_study_id
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