A Phase 3 interventional study of Roflumilast Cream 0.3% and Vehicle Cream in Atopic Dermatitis, Atopic Dermatitis (AD) and Atopic Dermatitis (Eczema), sponsored by Arcutis Biotherapeutics, Inc.. Recruiting at 4 sites in United States. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Arcutis Biotherapeutics, Inc. · Phase 3, Interventional, and Treatment
This Phase 3 study is designed to evaluate the efficacy and safety of once-daily roflumilast cream 0.3% in children, adolescents, and adults with moderate to severe atopic dermatitis. Approximately 415 participants will be randomized in a 2:1 ratio to receive roflumilast cream 0.3% or matching vehicle cream during a 4-week double-blind, vehicle-controlled treatment period.
Following completion of the double-blind treatment period, all participants will enter a 48-week open-label extension and receive roflumilast cream 0.3%. The study will assess the efficacy of roflumilast cream 0.3% in improving signs and symptoms of atopic dermatitis and evaluate its long-term safety and tolerability through Week 52.
This Phase 3, multicenter, randomized, double-blind, vehicle-controlled study is designed to evaluate the efficacy, safety, and tolerability of once-daily roflumilast cream 0.3% in children, adolescents, and adults with moderate to severe atopic dermatitis.
Approximately 415 participants aged 6 years and older with moderate to severe atopic dermatitis will be randomized in a 2:1 ratio to receive either roflumilast cream 0.3% or matching vehicle cream once daily for 4 weeks during the double-blind treatment period.
The primary objective of the study is to evaluate the efficacy of roflumilast cream 0.3% compared with vehicle cream at Week 4. Secondary objectives include evaluation of additional efficacy measures related to the signs and symptoms of atopic dermatitis.
Participants who complete the double-blind treatment period will be eligible to enter a 48-week open-label extension period, during which all participants will receive once-daily roflumilast cream 0.3%. The open-label extension is designed to evaluate the long-term safety, tolerability, and efficacy of roflumilast cream 0.3% through Week 52.
Safety assessments will include adverse events, local tolerability, clinical laboratory evaluations, vital signs, physical examinations, and other protocol-specified safety assessments.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's planned enrollment of 415 is above the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →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.
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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.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will apply matching vehicle cream once daily during the 4-week double-blind treatment period.
Drug: Vehicle Cream
Participants will apply roflumilast cream 0.3% once daily during the 4-week double-blind treatment period.
Drug: Roflumilast Cream 0.3%
Roflumilast cream 0.3% administered topically once daily to affected areas during the 4-week double-blind treatment period. Participants may continue treatment with roflumilast cream 0.3% during the 48-week open-label extension.
Matching vehicle cream administered topically once daily to affected areas during the 4-week double-blind treatment period. Participants will receive roflumilast cream 0.3% during the open-label extension phase.
Achievement of vIGA-AD Success at Week 4
vIGA-AD Success is defined as achieving a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of Clear (0) or Almost Clear (1) with at least a 2-grade improvement from Baseline.
Time frame: Week 4
Achievement of at least a 75% reduction in the Eczema Area and Severity Index (EASI-75)
EASI-75 is defined as achieving at least a 75% reduction from Baseline in Eczema Area and Severity Index (EASI) score.
Time frame: Week 4
In participants ≥12 years old with Baseline Itch-NRS ≥ 4, achievement of at least a 4-point reduction on the Itch-NRS
In participants aged ≥12 years and older with a Baseline Itch Numeric Rating Scale (Itch-NRS) score of 4 or greater who achieve at least a 4-point reduction from Baseline in the Itch-NRS score at Week 4. The Itch-NRS is an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), with higher scores indicating greater itch severity.
Time frame: Week 4
Plan to share: Undecided
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Roflumilast
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