A Phase 1 interventional study of ARQ-154 Foam 0.3% in Psoriasis, sponsored by Arcutis Biotherapeutics, Inc.. Completed at 5 sites in United States. Open to participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Arcutis Biotherapeutics, Inc. · Phase 1, Interventional, and Treatment
Among 12 studies in Psoriasis by Arcutis Biotherapeutics, Inc. — none open to participants now, none under way, none of them phase 3. Psoriasis · Arcutis Biotherapeutics, Inc..
Among the 12 studies in Psoriasis by Arcutis Biotherapeutics, Inc., this one is the 10th largest by enrollment, is the only one that started in 2025, is one of 2 in phase 1, and was the 12th registered.
2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.
This study's enrollment of 22 is below the median of 75 across 1,565 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →None of the 12 studies in Psoriasis by Arcutis Biotherapeutics, Inc. is open now.
Of the 174 Psoriasis studies recruiting now, 91 (52%) set no upper age limit and 67 (39%) stop at 75 or younger; 25 take children under 18; 40 take healthy volunteers.
This study: 2 Years to 12 Years · all sexes · no healthy volunteers.
The full table on the hub →12 studies; the count open now beside each. This study's row is marked.
First in 2017; this study’s year is marked. 1 started in 2025.
Median enrollment 318 across the 12 interventional studies. Of the 12 that completed or were terminated, 10 (83%) have results posted.
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.
None of the studies under way reaches primary completion within a year.
Among the 12 studies in Psoriasis by Arcutis Biotherapeutics, Inc., from their registry updates:
Nothing recorded among them since 2026-09-25.
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%.
ARQ-154-127 is a Phase 1, open-label, single arm, maximum usage pharmacokinetic and safety study of roflumilast foam 0.3% in participants with scalp and body psoriasis.
The goal of the study is to:
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.
Exclusion Criteria:
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.
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.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ARQ-154 foam 0.3% will be applied QD. Treatment duration will be up to 6 weeks, including 2 weeks under maximal usage conditions, followed by an optional 4 weeks under non-maximal usage conditions.
Drug: ARQ-154 Foam 0.3%
ARQ-154 Foam 0.3%
Concentration of Roflumilast and Roflumilast N-Oxide from plasma
Assessment of steady-state trough plasma concentrations after 2 weeks of study drug administration.
Time frame: 2 Weeks
Participant incidence of adverse events
Number of participants with adverse events during treatment will be assessed
Time frame: 6 Weeks
Incidence of application site reactions
Number of participants that experience an application site skin reaction by investigator assessment and participant assessment will be assessed
Time frame: 6 Weeks
The incidence of changes from Baseline in the total Children's Depression Inventory 2 (CDI-2)score.
The CDI-2 is an assessment instrument used to evaluate the severity of depressive symptoms in children.
Time frame: 6 Weeks
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: ARQ-154
Arcutis Biotherapeutics, Inc. →