Status:
COMPLETED
Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED)
Lead Sponsor:
Arcutis Biotherapeutics, Inc.
Conditions:
Atopic Dermatitis Eczema
Eligibility:
All Genders
2-5 years
Phase:
PHASE3
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 ato...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2023
Estimated Enrollment :
652 Patients enrolled
Trial Details
Trial ID
NCT04845620
Start Date
April 7 2021
End Date
June 1 2023
Last Update
December 23 2025
Active Locations (76)
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1
Arcutis Clinical Site 56
Birmingham, Alabama, United States, 35209
2
Arcutis Clinical Site 14
Birmingham, Alabama, United States, 35244
3
Arcutis Clinical Site 69
Montgomery, Alabama, United States, 36117
4
Arcutis Clinical Site 68
Gilbert, Arizona, United States, 85234