Atopic DermatitisPhase 3INTEGUMENT 3NCT07916480
Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
A Phase 3 study testing Roflumilast Cream 0.3% in people with Atopic Dermatitis and Atopic Dermatitis (AD), run by Arcutis Biotherapeutics, Inc. at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Atopic Dermatitis, Atopic Dermatitis (AD), Atopic Dermatitis (Eczema)
- What is being tested?
- Roflumilast Cream 0.3%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 415 participants
- Where
- 4 sitesUnited States
- Study dates
- 30 Oct 2026to 28 Mar 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female participants aged 6 years and older.
- Clinical diagnosis of moderate to severe atopic dermatitis.
- vIGA-AD score of 3 (Moderate) or 4 (Severe) at baseline.
- EASI score ≥5 at baseline.
- Atopic dermatitis involvement of ≥3% and ≤30% body surface area.
- Able and willing to comply with study procedures.
- Participant or parent/legal guardian able to provide informed consent/assent.
Who cannot join
- Uncontrolled medical conditions that could interfere with study participation.
- Skin disorders that may confound study assessments.
- Active infection requiring systemic treatment.
- Known hypersensitivity to roflumilast or formulation components.
- Use of prohibited medications within protocol-defined washout periods.
- Pregnant or breastfeeding participants.
- Participation in another interventional clinical trial within the protocol-defined timeframe.
- Any condition that, in the investigator's opinion, would make participation unsafe or interfere with study results.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Arcutis Site 324
Birmingham, Alabama, 35244
- Recruiting
Arcutis Site 337
Bryant, Arkansas, 72022
- Recruiting
Arcutis Site 320
Chicago, Illinois, 60523
- Recruiting
Arcutis Site 321
Miami Lakes, Florida, 33014
About this study
Official title: A Phase 3, 52-Week Study of Once-Daily Roflumilast Cream 0.3% in Participants With Moderate to Severe Atopic Dermatitis, Including a 4-Week Double-Blind, Vehicle-Controlled Phase Followed by a 48-Week Open-Label Extension
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.
Read the detailed description
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.
- Being tested
- Roflumilast Cream 0.3%, Vehicle Cream
- Keywords
- Atopic Dermatitis, Eczema, Roflumilast, Roflumilast Cream, Phosphodiesterase 4 Inhibitor, PDE4 Inhibitor, Moderate Atopic Dermatitis, Severe Atopic Dermatitis, Pruritus, Inflammatory Skin Disease, Topical Therapy, Dermatology
- Medical subject headings
- Dermatitis, Atopic, Eczema, Pruritus, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roflumilast Cream 0.3%Drug
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.
Vehicle CreamDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Vehicle Cream | Placebo comparator | Participants will apply matching vehicle cream once daily during the 4-week double-blind treatment period. Receives: Drug: Vehicle Cream |
| Roflumilast Cream 0.3% | Experimental | Participants will apply roflumilast cream 0.3% once daily during the 4-week double-blind treatment period. Receives: Drug: Roflumilast Cream 0.3% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 4
Secondary outcomes (2)
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.
Measured: 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.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start30 Oct 2026
- Primary completion27 Apr 2028 (estimated)
- Study completion28 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment study in which participants are randomized 2:1 to roflumilast cream 0.3% or vehicle cream for 4 weeks, followed by a 48-week open-label extension during which all participants receive roflumilast cream 0.3%.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 415 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arcutis Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916480
- Sponsor's protocol ID
- ARQ-151-323
- Acronym
- INTEGUMENT 3
- Status last verified
- Nov 2026
- First submitted
- 30 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, 52-Week Study of Once-Daily Roflumilast Cream 0.3% in Participants With Moderate to Severe Atopic Dermatitis, Including a 4-Week Double-Blind, Vehicle-Controlled Phase Followed by a 48-Week Open-Label Extension
- ClinicalTrials.gov ID
- NCT07916480
- Acronym / sponsor ID
- INTEGUMENT 3 / ARQ-151-323
- Keywords
- Atopic Dermatitis, Eczema, Roflumilast, Roflumilast Cream, Phosphodiesterase 4 Inhibitor, PDE4 Inhibitor, Moderate Atopic Dermatitis, Severe Atopic Dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 415 participants (estimated)
- Lead sponsor
- Arcutis Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Oct 2026 (actual)
- Primary completion
- 27 Apr 2028 (estimated)
- Study completion
- 28 Mar 2029 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel assignment study in which participants are randomized 2:1 to roflumilast cream 0.3% or vehicle cream for 4 weeks, followed by a 48-week open-label extension during which all participants receive roflumilast cream 0.3%.
| Arm | Type | Receives |
|---|---|---|
| Vehicle Cream | Placebo comparator | Drug: Vehicle CreamParticipants will apply matching vehicle cream once daily during the 4-week double-blind treatment period. |
| Roflumilast Cream 0.3% | Experimental | Drug: Roflumilast Cream 0.3%Participants will apply roflumilast cream 0.3% once daily during the 4-week double-blind treatment period. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female participants aged 6 years and older.
- Clinical diagnosis of moderate to severe atopic dermatitis.
- vIGA-AD score of 3 (Moderate) or 4 (Severe) at baseline.
- EASI score ≥5 at baseline.
- Atopic dermatitis involvement of ≥3% and ≤30% body surface area.
Key exclusion criteria (8 listed)
- Uncontrolled medical conditions that could interfere with study participation.
- Skin disorders that may confound study assessments.
- Active infection requiring systemic treatment.
- Known hypersensitivity to roflumilast or formulation components.
- Use of prohibited medications within protocol-defined washout periods.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Roflumilast Cream 0.3% |
| Vehicle CreamMatching 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. | Drug | Vehicle Cream |
Primary outcome
Achievement of vIGA-AD Success at Week 4
Time frame: 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.
2 secondary outcomes
Achievement of at least a 75% reduction in the Eczema Area and Severity Index (EASI-75)
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
Time frame: Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Roflumilast Cream 0.3% in people with Atopic Dermatitis and Atopic Dermatitis (AD), run by Arcutis Biotherapeutics, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arcutis Medical Information (1-844-692-6729, medinfo@arcutis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achievement of vIGA-AD Success at Week 4 (time frame: Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.