CompletedNCT04746911Updated Aug 7, 2026Results posted

Maximal Usage Pharmacokinetics and Safety of ARQ-151 in Children With Plaque Psoriasis (ARQ-151-216)

A Phase 2 interventional study of ARQ-151 cream 0.3% in Psoriasis and Plaque Psoriasis, sponsored by Arcutis Biotherapeutics, Inc.. Completed at 18 sites in 3 countries. Open to participants aged 2 Years to 5 Years. Per ClinicalTrials.gov, last updated 2026-08-07.

Sponsored by Arcutis Biotherapeutics, Inc. · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 10
Allocation: Not applicable
Ages: 2 Years to 5 Years
Sex: All

Study summary

This is a Phase 2, open label, maximal usage PK and safety study of ARQ-151 cream 0.3% in pediatric subjects (ages 2 to 5 years old) with plaque psoriasis:

Conditions studied

Psoriasis
Plaque Psoriasis

Browse trials for

Psoriasis 2,028

In context

Psoriasis

2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.

This study's enrollment of 10 is below the median of 75 across 1,565 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Arcutis Biotherapeutics, Inc. is the lead sponsor of 26 studies on the registry; 2 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 20 (83%) have results posted.

Browse Arcutis Biotherapeutics, Inc. studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 2 Years to 5 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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 (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

Exclusion Criteria:

Subjects with any serious medical or psychiatric condition or laboratory, , 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 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.

Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 10 participants (actual)

Study arms

Experimental
ARQ-151 cream 0.3%
Open label study of ARQ-151 cream 0.3% applied once daily for 4 weeks
Drug: ARQ-151 cream 0.3%

Interventions

DrugARQ-151 cream 0.3%
ARQ-151 cream 0.3% applied to chronic plaque psoriasis lesions once a day for 4 weeks
Also known as: Topical roflumilast

What researchers measure

Primary outcomes

Plasma Concentration of Roflumilast Following Daily Application of Roflumilast Cream 0.3%
The plasma concentration of roflumilast at Weeks 2 and 4 is reported.
Time frame: Weeks 2 and 4: 1 hour predose
Plasma Concentration of Major N-oxide Metabolite Following Daily Application of Roflumilast Cream 0.3%
The plasma concentration of the major N-oxide metabolite of roflumilast at Weeks 2 and 4 is reported.
Time frame: Weeks 2 and 4: 1 hour predose
Number of Participants With an Adverse Event (AE)
The number of participants with an AE during the treatment period is reported. An AE is any untoward medical
Time frame: Up to 4 weeks
Number of Participants With Application Site Reactions
The number of subjects that experience an application site skin reaction by investigator assessment or application site reactions reported as AEs is reported.
Time frame: Up to 4 weeks

Results

Posted Aug 7, 2026

Participant flow

Pediatric (2 to 5 years of age) participants were enrolled at study sites in the United States, Canada, and Dominican Republic.

Participant flow — Overall Study
Milestone	Roflumilast Cream 0.3%
Started	10
Completed	10
Not completed	0

Outcome measures

PrimaryPlasma Concentration of Roflumilast Following Daily Application of Roflumilast Cream 0.3%

The plasma concentration of roflumilast at Weeks 2 and 4 is reported.

Time frame:: Weeks 2 and 4: 1 hour predose
Reported as:: Mean · ng/mL

Plasma Concentration of Roflumilast Following Daily Application of Roflumilast Cream 0.3%
ng/mL	Roflumilast Cream 0.3%
Week 2	2.15 ± 1.25
Week 4	2.04 ± 1.33

PrimaryPlasma Concentration of Major N-oxide Metabolite Following Daily Application of Roflumilast Cream 0.3%

The plasma concentration of the major N-oxide metabolite of roflumilast at Weeks 2 and 4 is reported.

Time frame:: Weeks 2 and 4: 1 hour predose
Reported as:: Mean · ng/mL

Plasma Concentration of Major N-oxide Metabolite Following Daily Application of Roflumilast Cream 0.3%
ng/mL	Roflumilast Cream 0.3%
Week 2	22.4 ± 15.5
Week 4	15.8 ± 9.91

PrimaryNumber of Participants With an Adverse Event (AE)

The number of participants with an AE during the treatment period is reported. An AE is any untoward medical

Time frame:: Up to 4 weeks
Reported as:: Count of participants · Participants

Number of Participants With an Adverse Event (AE)
Participants	Roflumilast Cream 0.3%
Number of Participants With an Adverse Event (AE)	1

PrimaryNumber of Participants With Application Site Reactions

The number of subjects that experience an application site skin reaction by investigator assessment or application site reactions reported as AEs is reported.

Time frame:: Up to 4 weeks
Reported as:: Count of participants · Participants

Number of Participants With Application Site Reactions
Participants	Roflumilast Cream 0.3%
Number of Participants With Application Site Reactions	0

Adverse events

Collected over Up to 4 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Roflumilast Cream 0.3%	0/10 (0%)	0/10 (0%)	1/10 (10%)

Most frequent other events

Most frequent other events
Event	Roflumilast Cream 0.3%
HeadacheNervous system disorders	1/10

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Roflumilast Cream 0.3%
Mean	3.6 ± 1.26

Sex: Female, Male
Sex: Female, Male(Participants)	Roflumilast Cream 0.3%
Female	5
Male	5

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Roflumilast Cream 0.3%
Hispanic or Latino	9
Not Hispanic or Latino	1
Unknown or Not Reported	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Roflumilast Cream 0.3%
American Indian or Alaska Native	0
Asian	0
Native Hawaiian or Other Pacific Islander	0
Black or African American	9
White	1
More than one race	0
Unknown or Not Reported	0

Study locations

18 sites

Arcutis Clinical Site 603
Mountain Brook, Alabama 35223, United States
Arcutis Clinical Site 604
Scottsdale, Arizona 85255, United States
Arcutis Clinical Site 609
Fountain Valley, California 92708, United States
Arcutis Clinical Site 618
Los Angeles, California 90017, United States
Arcutis Clinical Site 608
Los Angeles, California 90057, United States
Arcutis Clinical Site 611
Rancho Santa Margarita, California 92688, United States
Arcutis Clinical Site 610
Boca Raton, Florida 33428, United States
Arcutis Clinical Site 602
Coral Gables, Florida 33146, United States
Arcutis Clinical Site 613
Delray Beach, Florida 33484, United States
Arcutis Clinical Study Site 628
Miami, Florida 33125, United States
Arcutis Clinical Site 607
Miami, Florida 33155, United States
Arcutis Clinical Site 627
West Lafayette, Indiana 47906, United States
Arcutis Clinical Site 606
Arlington, Texas 76001, United States
Arcutis Clinical Site 619
Frisco, Texas 75034, United States
Arcutis Clinical Study Site 619
Frisco, Texas 75034, United States
Arcutis Clinical Site 605
Houston, Texas 77030, United States
Arcutis Clinical Site 621
Toronto, Ontario M5G 1X8, Canada
Arcutis Clinical Site 630
Santo Domingo, Dominican Republic

References and documents

Publications

Hebert AA, Guide SV, Groysman V, Gonzalez ME, Blanco D, Laquer V, Seal MS, Thurston A, Krupa D, Snyder S, Burnett P, Chu DH, Berk DR, Higham RC. Early Evidence of Safety, Clinical Benefit, and Pharmacokinetics of Roflumilast Cream 0.3% Once Daily for Treatment of Mild or Moderate Plaque Psoriasis in Children Aged 2-11 Years. Pediatr Dermatol. 2026 Jan-Feb;43(1):105-108. doi: 10.1111/pde.70013. Epub 2025 Aug 27. PubMed 40862624 ↗

Study documents

Study protocol ↗ · Feb 3, 2021
Statistical analysis plan ↗ · Jul 7, 2022

PDFs hosted by the registry, ClinicalTrials.gov.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2021 to primary completion in May 2022, 14 months.

Results were first posted in Aug 2026, 4 years 2 months after primary completion. A results delay was requested in Mar 2023.

Of 145 industry-sponsored phase 2 interventional studies under Psoriasis, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 20. This study's 14 months is above that.

Counting every sponsor, half of 174 studies reached it within 14 months; a quarter within 9 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered: Feb 5, 2021
First posted: Feb 10, 2021
StartActual: Mar 1, 2021
Primary completionActual: May 11, 2022
CompletionActual: May 11, 2022
Results delay requested: Mar 7, 2023
Results first posted: Aug 7, 2026
Last update: Aug 7, 2026

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Aug 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04746911
Lead sponsor: Arcutis Biotherapeutics, Inc.
Responsible party: Sponsor
First posted: Feb 10, 2021
Start date: Mar 1, 2021
Primary completion: May 11, 2022
Completion: May 11, 2022
Results posted: Aug 7, 2026
Last update: Aug 7, 2026

Study contacts

David Berk, MD

study director · Arcutis Biotherapeutics, Inc.

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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