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Phosphodiesterase-4 (PDE-4) Inhibitor
Topical Roflumilast to Treat Scalp and Body Psoriasis (ARRECTOR) (ARRECTOR Trial)
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 8
Awards & highlights
Pivotal Trial
Summary
This trial tests ARQ-154 foam on people with scalp and body psoriasis. The foam is applied regularly and aims to reduce redness, itching, and scaling by calming the skin and slowing down rapid skin cell growth.
Eligible Conditions
- Psoriasis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 8
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Body Investigator Global Assessment (B-IGA) Score Change
Scalp Investigator Global Assessment (S-IGA) Score Change
Secondary study objectives
Change From Baseline (CFB) in PSD (Psoriasis Symptoms Diary) items related to Itching, Pain, and Scaling (Questions 1, 9, and 11) aggregate score at Week 8
Change from Baseline (CFB) SI-NRS (Scalp Itch-Numeric Rating Score)
Change from Baseline (CFB) in PASI (Psoriasis Scalp Severity Index)
+11 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: ARQ-154 Foam 0.3%Active Control1 Intervention
ARQ-154 Foam 0.3%
Group II: ARQ-154 VehiclePlacebo Group1 Intervention
ARQ-154 Vehicle
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Who is running the clinical trial?
Arcutis Biotherapeutics, Inc.Lead Sponsor
21 Previous Clinical Trials
7,209 Total Patients Enrolled
10 Trials studying Psoriasis
2,328 Patients Enrolled for Psoriasis
David Berk, MDStudy DirectorArcutis Biotherapeutics, Inc.
21 Previous Clinical Trials
8,203 Total Patients Enrolled
8 Trials studying Psoriasis
1,798 Patients Enrolled for Psoriasis