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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 below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4 for reporting.

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 more

Trial 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

Find a Location

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

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~167 spots leftby Mar 2025