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
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Arcutis Clinical Study Site 104 Coordinator of this site? Confirm its status | Arlington | United States | Unknown status |
| Arcutis Clinical Study Site 106 Coordinator of this site? Confirm its status | Bryant | United States | Unknown status |
| Arcutis Clinical Study Site 108 Coordinator of this site? Confirm its status | Meridian | United States | Unknown status |
| Arcutis Clinical Study Site 107 Coordinator of this site? Confirm its status | Miami Lakes | United States | Unknown status |
| Arcutis Clinical Study Site 105 Coordinator of this site? Confirm its status | West Lafayette | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.