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

Completed · Phase 3

Conditions studied: Atopic Dermatitis Eczema

In brief

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).

Key facts

Study ID

NCT04845620

Run by

Arcutis Biotherapeutics, Inc.

People needed

652

Starts

2021-04-07

Expected to finish

2023-06-01

Last updated by the study team

2025-12-23

Who can join

Age: 2 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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 56 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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