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Can a Once-Daily cream tame psoriasis in toddlers?

NCT ID NCT04746911

Disease control 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 07, 2026 · Last updated Aug 07, 2026

Summary

This trial tests whether a once-daily application of ARQ-151 cream 0.3% is safe and well-tolerated in children aged 2 to 5 with plaque psoriasis. Over four weeks, researchers measure how much of the drug enters the bloodstream and watch for any side effects or skin reactions. The goal is to see if this cream could be a viable treatment option for young children with this skin condition.

What this could mean

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

Active substance
ARQ-151 cream 0.3% (topical roflumilast)
What this could lead to
If successful, this could lead to a new topical treatment option for young children with plaque psoriasis, potentially easing symptoms with fewer side effects than systemic medications.
What could go wrong
This is a small, early-phase study with only 10 participants, so results may not apply broadly. The cream may cause skin reactions or not work as well in real-world use.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

10 people

The number who actually took part.

Started

Mar 2021

Finished

May 2022

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 5 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: * Informed consent of parent(s) or legal guardian. * Males or females, 2 to 5 years old (inclusive). * Clinical diagnosis of psoriasis vulgaris of at least 2 months duration as determined by the Investigator or through subject interview. Stable disease for the past 3 weeks. * Psoriasis vulgaris on the face, extremities, trunk, and/or intertriginous areas involving at least 2% of BSA (excluding the scalp, palms, and soles). * An Investigator Global Assessment of disease severity (IGA) of at least Mild ('2') at Baseline. * Subject has adequate venous access for PK sampling in areas not involved by plaque psoriasis and not being treated with ARQ-151 (e.g., back of the hands). * In good health as judged by the Investigator, based on medical history, physical examination, 12-lead electrocardiogram (ECG), serum chemistry labs and hematology values. * Subjects and parent(s)/legal guardian(s) are considered reliable and capable of adhering to the Protocol and Visit Schedule, according to the judgment of the Investigator. Exclusion Criteria: * Subjects with any serious medical or psychiatric condition or clinically significant laboratory, ECG, vital signs, or physical examination abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator. * Planned initiation or changes to concomitant medication that could, in the opinion of the Investigator, affect psoriasis vulgaris * Current diagnosis of non-plaque form of psoriasis (e.g., guttate, erythrodermic/exfoliative, palmoplantar only involvement, or pustular psoriasis). Current diagnosis of drug-induced psoriasis. * Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements. * Subjects who cannot discontinue the use of strong cytochrome P-450 CYP3A4 inducers for 2 weeks prior to Baseline/Day 1and during the study period. * Subjects who cannot discontinue the use of strong cytochrome P-450 CYP3A4 inhibitors for 2 weeks prior to Baseline/Day 1 and during the study period. * Subjects who are unwilling to refrain from prolonged sun exposure and from using a tanning bed or other artificial light emitting devices (LEDs) for 4 weeks prior to Baseline/Day 1 and during the study. * Subjects who cannot discontinue specific systemic therapies and/or topical therapies prior to the Baseline/Day 1 and during the study period according to the protocol. * Subjects with any infection requiring oral or intravenous administration of antibiotics, antifungal or antiviral agents within 2 weeks prior to Baseline/Day 1.

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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.

Plaque psoriasis Psoriasis

Contacts and locations

Locations

  • Arcutis Clinical Site 602

    Coral Gables, Florida, 33146, United States

  • Arcutis Clinical Site 603

    Mountain Brook, Alabama, 35223, United States

  • Arcutis Clinical Site 604

    Scottsdale, Arizona, 85255, United States

  • Arcutis Clinical Site 605

    Houston, Texas, 77030, United States

  • Arcutis Clinical Site 606

    Arlington, Texas, 76001, United States

  • Arcutis Clinical Site 607

    Miami, Florida, 33155, United States

  • Arcutis Clinical Site 608

    Los Angeles, California, 90057, United States

  • Arcutis Clinical Site 609

    Fountain Valley, California, 92708, United States

  • Arcutis Clinical Site 610

    Boca Raton, Florida, 33428, United States

  • Arcutis Clinical Site 611

    Rancho Santa Margarita, California, 92688, United States

  • Arcutis Clinical Site 613

    Delray Beach, Florida, 33484, United States

  • Arcutis Clinical Site 618

    Los Angeles, California, 90017, United States

  • Arcutis Clinical Site 619

    Frisco, Texas, 75034, United States

  • Arcutis Clinical Site 621

    Toronto, Ontario, M5G 1X8, Canada

  • Arcutis Clinical Site 627

    West Lafayette, Indiana, 47906, United States

  • Arcutis Clinical Site 630

    Santo Domingo, Dominican Republic

  • Arcutis Clinical Study Site 619

    Frisco, Texas, 75034, United States

  • Arcutis Clinical Study Site 628

    Miami, Florida, 33125, United States

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