Safety and Efficacy of ARQ-151 Cream in Adolescents and Adults With Atopic Dermatitis
Recruiting in Palo Alto (17 mi)
+19 other locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Arcutis Biotherapeutics, Inc.
Prior Safety Data
Trial Summary
What is the purpose of this trial?
The study will assess the safety, pharmacokinetics (PK), and efficacy of different doses of roflumilast (ARQ-151) cream (0.05% and 0.15%) vs placebo applied once daily (QD) for 28 days by adolescents and adults with atopic dermatitis.
Research Team
DB
David Berk, MD
Principal Investigator
Arcutis Biotherapeutics, Inc.
Eligibility Criteria
Inclusion Criteria
Participants legally competent to sign and give informed consent or, in the case of adolescents, assent with consent of a parent(s) or legal guardian, as required by local laws.
Males and females ages 12 years and older (inclusive) at the time of consent.
Clinical diagnosis of active atopic dermatitis for at least 6 months.
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Treatment Details
Interventions
- ARQ-151 Cream (Phosphodiesterase-4 (PDE-4) Inhibitor)
- ARQ-151 Cream Vehicle (Topical Cream)
- Roflumilast Cream (Phosphodiesterase-4 (PDE-4) Inhibitor)
- Vehicle Cream (Topical Cream)
Participant Groups
3Treatment groups
Active Control
Placebo Group
Group I: Roflumilast Cream 0.15%Active Control1 Intervention
Participants apply roflumilast cream 0.15% QD for 28 days.
Group II: Roflumilast Cream 0.05%Active Control1 Intervention
Participants apply roflumilast cream 0.05% QD for 28 days.
Group III: Vehicle CreamPlacebo Group1 Intervention
Participants apply vehicle cream QD for 28 days.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Arcutis Clinical Site 25Scottsdale, AZ
Arcutis Clinical Site 10Richmond Hill, Canada
Arcutis Clinical Site 06Montréal, Canada
Arcutis Clinical Site 01San Diego, CA
More Trial Locations
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Who Is Running the Clinical Trial?
Arcutis Biotherapeutics, Inc.
Lead Sponsor
Trials
22
Patients Recruited
7,600+