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Phosphodiesterase-4 (PDE4) Inhibitor
Roflumilast (ARQ-151) cream 0.15% for Atopic Dermatitis
Phase 3
Waitlist Available
Research Sponsored by Arcutis Biotherapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants legally competent to sign and give informed consent and, if appropriate, assent as required by local laws.
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 4
Awards & highlights
Study Summary
This study is evaluating whether a cream may help treat atopic dermatitis.
Eligible Conditions
- Atopic Dermatitis
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 4
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
IGA Success, defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline at Week 4.
Secondary outcome measures
Achievement of at least a 75% (percent) reduction in the Eczema Area andSeverity Index (EASI-75) at Week 4
In subjects with baseline WI-NRS ≥ 4, achievement of a 4 point reduction inthe WI-NRS at Week 1
In subjects with baseline WI-NRS ≥ 4, achievement of a 4 point reduction inthe WI-NRS at Week 2
+7 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Roflumilast (ARQ-151) cream 0.15%Active Control1 Intervention
Active comparator
Group II: Vehicle creamPlacebo Group1 Intervention
Placebo comparator
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Who is running the clinical trial?
Arcutis Biotherapeutics, Inc.Lead Sponsor
21 Previous Clinical Trials
6,958 Total Patients Enrolled
David Berk, MDStudy DirectorArcutis Biotherapeutics, Inc.
21 Previous Clinical Trials
7,952 Total Patients Enrolled
Frequently Asked Questions
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