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New foam for Kids' psoriasis shows early promise

NCT ID NCT07340216

Symptom relief Sponsor: Arcutis Biotherapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase study tested a medicated foam called ARQ-154 (roflumilast) in 22 children aged 2 to 12 with scalp and body psoriasis. The goal was to see how much of the drug enters the bloodstream and whether it is safe. Researchers monitored side effects and skin reactions over two weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Roflumilast foam 0.3%
What this could lead to
If it works, this could provide a new topical treatment option for children with psoriasis, potentially easing symptoms like scaling and itching.
What could go wrong
This is a very early Phase 1 study with only 22 children, so it is mainly checking safety and drug levels, not whether it works well. Side effects or lack of effectiveness may still arise.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

22 people

The number who actually took part.

Started

Dec 2025

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 12 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 with skin conditions other than psoriasis vulgaris that would interfere with evaluations of the effect of the study medication, as determined by the Investigator. * 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. * 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 \[HIV\]). * Participants who are family members of the clinical study staff or sponsor.

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Conditions

The condition(s) this trial relates to.

psoriasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Psoriasis

Contacts and locations

Locations

  • Arcutis Clinical Study Site 104

    Arlington, Texas, 76011, United States

  • Arcutis Clinical Study Site 105

    West Lafayette, Indiana, 47906, United States

  • Arcutis Clinical Study Site 106

    Bryant, Arkansas, 72022, United States

  • Arcutis Clinical Study Site 107

    Miami Lakes, Florida, 33014, United States

  • Arcutis Clinical Study Site 108

    Meridian, Idaho, 83646, United States

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