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Topical Agent

ARQ-151 cream 0.15% for Atopic Dermatitis

Phase 1
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
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 2, week 4
Awards & highlights

Study Summary

This trial will study how well ARQ-151 works in treating mild to moderate atopic dermatitis in adolescent and pediatric subjects. The trial will also study the safety and side effects of the medication.

Eligible Conditions
  • Atopic Dermatitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 2, week 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 2, 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
Area under the plasma concentration-time curve within a dosing interval (AUC) for roflumilast and its N-oxide metabolite
Maximum Plasma Concentration (Cmax) of roflumilast and its N-oxide metabolite
Treatment Emergent Adverse Events (TEAE)
Secondary outcome measures
Achievement of a Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) score of 'clear' or 'almost clear' at each study visit, or 'clear' or 'almost clear' with a 2-point improvement from baseline at each study visit
Body Surface Area (BSA) Involvement Change
Change from baseline in vIGA-AD score at each study visit
+4 more

Side effects data

From 2018 Phase 1 & 2 trial • 91 Patients • NCT03392168
16%
Application site pain
13%
Application site erythema
6%
Influenza
6%
Muscle strain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 2 - ARQ-151 Vehicle Cream
Cohort 2 - ARQ-151 Cream 0.15%
Cohort 2 - ARQ-151 Cream 0.5%
Cohort 1 - ARQ-151 Cream 0.5%

Trial Design

1Treatment groups
Experimental Treatment
Group I: ARQ-151 cream 0.15% or 0.05%Experimental Treatment2 Interventions
Open-label study of 0.15% or 0.05% active concentration
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ARQ-151 cream 0.15%
2017
Completed Phase 2
~200
ARQ-151 cream 0.05%
2019
Completed Phase 1
~110

Find a Location

Who is running the clinical trial?

Arcutis Biotherapeutics, Inc.Lead Sponsor
21 Previous Clinical Trials
7,540 Total Patients Enrolled
David Berk, MDStudy DirectorArcutis Biotherapeutics, Inc.
21 Previous Clinical Trials
8,534 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
California
How old are they?
< 18
What site did they apply to?
Arcutis Clinical Site 11
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Pharmacokinetics (PK), Safety, Efficacy and Maximal Use PK of ARQ-151 in Adolescents/Children With Mild/Moderate Eczema
2019. "Pharmacokinetics (PK), Safety, Efficacy and Maximal Use PK of ARQ-151 in Adolescents/Children With Mild/Moderate Eczema". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04156191.
~19 spots leftby Apr 2025
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