Sign in

NCT07340216CompletedPhase 1

Maximal Usage Pharmacokinetics and Safety Study of ARQ-154 Foam 0.3% in Pediatric Participants With Scalp and Body Psoriasis

An Open Label, Phase 1, Maximal Usage Pharmacokinetics and Safety Study of ARQ-154 Foam 0.3% Administered QD in Pediatric Participants With Scalp and Body Psoriasis

Source: ClinicalTrials.gov · Last updated 22 May 2026

Brief summary (registry, in English)

This study will evaluate the systemic exposure and characterize the plasma pharmacokinetic (PK) profile and assess the safety and tolerability of ARQ-154 foam 0.3%.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
22 (actual)
First submitted
19 Dec 2025
Start date
15 Dec 2025
Primary completion date
30 Apr 2026
Lead sponsor
Arcutis Biotherapeutics, Inc.
Diseases
Psoriasis
NCT number
NCT07340216

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 22
  • From 15 Dec 2025 to the primary completion date, 30 Apr 2026
  • 5 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants who cannot discontinue medications and treatments prior to Day 1 (first application of IP).
  • Current diagnosis of non-plaque forms of psoriasis. Current diagnosis of drug-induced psoriasis.
  • Participants who have significant active systemic or localized infection or have had any infection that required oral or intravenous administration of antibiotics, antifungal or antiviral agents within 7 days prior to Day 1.
  • Participants who cannot discontinue the use of strong cytochrome P-450 CYP3A4 inhibitors for 2 weeks prior to Day 1 and during the study period.

Other illness

  • Participants with skin conditions other than psoriasis vulgaris that would interfere with evaluations of the effect of the study medication, as determined by the Investigator.
  • A medical history of severe renal insufficiency, moderate to severe hepatic disorders (e.g., Child-Pugh B or C), or chronic infectious disease (e.g., hepatitis B, hepatitis C, or human immunodeficiency virus \[HIV\]).

Other

  • Participants who are family members of the clinical study staff or sponsor.

Who the study is looking for

  • Males and females, ages 2 years to \< 12 years old at Day 1.
  • Clinical diagnosis of psoriasis vulgaris of at least 2 months duration at Screening as determined by the Investigator.
  • Scalp psoriasis with an Investigator Global Assessment (S-IGA) of scalp disease severity of at least Moderate ('3') at Day 1.
  • An IGA of body (non-scalp) psoriasis (B-IGA) of at least Mild ('2') at Day 1.
  • Extent of scalp psoriasis involving ≥ 10% of the total scalp at Day 1.
  • Body psoriasis (non-scalp) involving at least 3% BSA on Day 1.

Age in the registry: 2 years to 12 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Arcutis Clinical Study Site 104
Coordinator of this site? Confirm its status
ArlingtonUnited StatesUnknown status
Arcutis Clinical Study Site 106
Coordinator of this site? Confirm its status
BryantUnited StatesUnknown status
Arcutis Clinical Study Site 108
Coordinator of this site? Confirm its status
MeridianUnited StatesUnknown status
Arcutis Clinical Study Site 107
Coordinator of this site? Confirm its status
Miami LakesUnited StatesUnknown status
Arcutis Clinical Study Site 105
Coordinator of this site? Confirm its status
West LafayetteUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.