A Phase 3 interventional study of Roflumilast Cream 0.05% and Vehicle Cream in Atopic Dermatitis Eczema, sponsored by Arcutis Biotherapeutics, Inc.. Completed at 76 sites in 2 countries. Open to participants aged 2 Years to 5 Years. Per ClinicalTrials.gov, last updated 2025-12-23.
Sponsored by Arcutis Biotherapeutics, Inc. · Phase 3, Interventional, and Treatment
This was a Phase 3, 4-week, double-blind study to assess the safety and efficacy of ARQ-151 cream compared to vehicle cream applied once daily (qd) for 4 weeks in children 2 to 5 years of age with atopic dermatitis (AD).
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's enrollment of 652 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.
Counted across the registry records on this site, refreshed daily.
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.
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.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants applied roflumilast cream 0.05% qd for 4 weeks.
Drug: Roflumilast Cream 0.05%
Participants applied vehicle cream qd for 4 weeks.
Drug: Vehicle Cream
Roflumilast cream for topical application.
Also known as: ARQ-151
Vehicle cream matched to roflumilast cream for topical application.
Achievement of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Success at Week 4
The percentage of participants with vIGA-AD success at Week 4 is presented. The vIGA-AD is a static evaluation of qualitative overall AD severity with five severity grades (reported as score of 0 'clear' to 4 'severe' with higher scores indicating greater symptom severity. vIGA success was defined as score of 'clear' or 'almost clear' plus a 2-grade improvement from baseline.
Time frame: Week 4
Achievement of vIGA-AD Success at Week 4 in Participants With 'Moderate' Baseline vIGA-AD
The percentage of participants with vIGA-AD success at Week 4 who had 'moderate' vIGA-AD score (vIGA score of 3) at baseline is presented. The vIGA-AD is a static evaluation of qualitative overall AD severity with five severity grades (reported as score of 0 'clear' to 4 'severe' with higher scores indicating greater symptom severity. vIGA-AD success was defined as score of 'clear' or 'almost clear' plus a 2-grade improvement from baseline in participants with moderate vIGA-AD baseline.
Time frame: Week 4
Achievement of 75% Reduction in the Eczema Area and Severity Index (EASI-75) at Week 4 In Participants With 'Moderate' Baseline vIGA
The percentage of participants with a moderate baseline vIGA-AD score who achieved EASI-75 is presented. EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head {10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI.
Time frame: Week 4
Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear'
The percentage of participants with vIGA-AD score of 'clear' or 'almost clear' at Week 4 is presented. The vIGA is a static evaluation of qualitative overall AD severity with five severity grades (reported as score of 0 'clear' to 4 'severe' with higher scores indicating greater symptom severity.
Time frame: Week 4
Achievement of vIGA-AD Success at Week 2
The percentage of participants with vIGA-AD success at Week 2 is presented. The vIGA-AD is a static evaluation of qualitative overall AD severity with five severity grades (reported as score of 0 'clear' to 4 'severe' with higher scores indicating greater symptom severity. vIGA success was defined as score of 'clear' or 'almost clear' plus a 2-grade improvement from baseline.
Time frame: Week 2
Achievement of vIGA-AD Success at Week 1
The percentage of participants with vIGA-AD success at Week 1 is presented. The vIGA-AD is a static evaluation of qualitative overall AD severity with five severity grades (reported as score of 0 'clear' to 4 'severe' with higher scores indicating greater symptom severity. vIGA-AD success was defined as score of 'clear' or 'almost clear' plus a 2-grade improvement from baseline.
Time frame: Week 1
Achievement of vIGA-AD of 'Clear' or 'Almost Clear' at Week 2
The percentage of participants with vIGA-AD score of 'clear' or 'almost clear' at Week 2 is presented. The vIGA-AD is a static evaluation of qualitative overall AD severity with five severity grades (reported as score of 0 'clear' to 4 'severe' with higher scores indicating greater symptom severity.
Time frame: Week 2
Achievement of vIGA-AD of 'Clear' or 'Almost Clear' at Week 1
The percentage of participants with vIGA-AD score of 'clear' or 'almost clear' at Week 1 is presented. The vIGA-AD is a static evaluation of qualitative overall AD severity with five severity grades (reported as score of 0 'clear' to 4 'severe' with higher scores indicating greater symptom severity.
Time frame: Week 1
| Milestone | Roflumilast Cream 0.05% | Vehicle Cream |
|---|---|---|
| Started | 437 | 215 |
| Completed | 410 | 192 |
| Not completed | 27 | 23 |
| Withdrew: Withdrawal by subject | 11 | 10 |
| Withdrew: Adverse event | 5 | 4 |
| Withdrew: Lost to follow-up | 5 | 4 |
| Withdrew: Lack of efficacy | 4 | 4 |
| Withdrew: Physician decision | 2 | 1 |
The percentage of participants with vIGA-AD success at Week 4 is presented. The vIGA-AD is a static evaluation of qualitative overall AD severity with five severity grades (reported as score of 0 'clear' to 4 'severe' with higher scores indicating greater symptom severity. vIGA success was defined as score of 'clear' or 'almost clear' plus a 2-grade improvement from baseline.
| percentage of participants | Roflumilast Cream 0.05% | Vehicle Cream |
|---|---|---|
| Achievement of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Success at Week 4 | 25.4 (20.95 to 30.34) | 10.7 (6.77 to 16.45) |
The percentage of participants with vIGA-AD success at Week 4 who had 'moderate' vIGA-AD score (vIGA score of 3) at baseline is presented. The vIGA-AD is a static evaluation of qualitative overall AD severity with five severity grades (reported as score of 0 'clear' to 4 'severe' with higher scores indicating greater symptom severity. vIGA-AD success was defined as score of 'clear' or 'almost clear' plus a 2-grade improvement from baseline in participants with moderate vIGA-AD baseline.
| percentage of participants | Roflumilast Cream 0.05% | Vehicle Cream |
|---|---|---|
| Achievement of vIGA-AD Success at Week 4 in Participants With 'Moderate' Baseline vIGA-AD | 27.7 (22.55 to 33.62) | 11.0 (6.67 to 17.73) |
The percentage of participants with a moderate baseline vIGA-AD score who achieved EASI-75 is presented. EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head {10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI.
| percentage of participants | Roflumilast Cream 0.05% | Vehicle Cream |
|---|---|---|
| Achievement of 75% Reduction in the Eczema Area and Severity Index (EASI-75) at Week 4 In Participants With 'Moderate' Baseline vIGA | 39.4 (34.21 to 44.81) | 20.6 (15.06 to 27.55) |
The percentage of participants with vIGA-AD score of 'clear' or 'almost clear' at Week 4 is presented. The vIGA is a static evaluation of qualitative overall AD severity with five severity grades (reported as score of 0 'clear' to 4 'severe' with higher scores indicating greater symptom severity.
| percentage of participants | Roflumilast Cream 0.05% | Vehicle Cream |
|---|---|---|
| Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' | 35.4 (30.39 to 40.66) | 14.6 (9.94 to 20.86) |
The percentage of participants with vIGA-AD success at Week 2 is presented. The vIGA-AD is a static evaluation of qualitative overall AD severity with five severity grades (reported as score of 0 'clear' to 4 'severe' with higher scores indicating greater symptom severity. vIGA success was defined as score of 'clear' or 'almost clear' plus a 2-grade improvement from baseline.
| percentage of participants | Roflumilast Cream 0.05% | Vehicle Cream |
|---|---|---|
| Achievement of vIGA-AD Success at Week 2 | 21.2 (17.13 to 25.98) | 6.8 (3.85 to 11.88) |
The percentage of participants with vIGA-AD success at Week 1 is presented. The vIGA-AD is a static evaluation of qualitative overall AD severity with five severity grades (reported as score of 0 'clear' to 4 'severe' with higher scores indicating greater symptom severity. vIGA-AD success was defined as score of 'clear' or 'almost clear' plus a 2-grade improvement from baseline.
| percentage of participants | Roflumilast Cream 0.05% | Vehicle Cream |
|---|---|---|
| Achievement of vIGA-AD Success at Week 1 | 9.4 (6.72 to 13.02) | 0.9 (0.22 to 3.88) |
The percentage of participants with vIGA-AD score of 'clear' or 'almost clear' at Week 2 is presented. The vIGA-AD is a static evaluation of qualitative overall AD severity with five severity grades (reported as score of 0 'clear' to 4 'severe' with higher scores indicating greater symptom severity.
| percentage of participants | Roflumilast Cream 0.05% | Vehicle Cream |
|---|---|---|
| Achievement of vIGA-AD of 'Clear' or 'Almost Clear' at Week 2 | 30.4 (25.67 to 35.58) | 10.6 (6.74 to 16.42) |
The percentage of participants with vIGA-AD score of 'clear' or 'almost clear' at Week 1 is presented. The vIGA-AD is a static evaluation of qualitative overall AD severity with five severity grades (reported as score of 0 'clear' to 4 'severe' with higher scores indicating greater symptom severity.
| percentage of participants | Roflumilast Cream 0.05% | Vehicle Cream |
|---|---|---|
| Achievement of vIGA-AD of 'Clear' or 'Almost Clear' at Week 1 | 17.00 (13.32 to 21.37) | 3.7 (1.73 to 7.83) |
Collected over Up to ~6 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Roflumilast Cream 0.05% | 0/437 (0%) | 1/437 (0.2%) | 0/437 (0%) |
| Vehicle Cream | 0/215 (0%) | 0/215 (0%) | 0/215 (0%) |
| Event | Roflumilast Cream 0.05% | Vehicle Cream |
|---|---|---|
| CellulitisSkin and subcutaneous tissue disorders | 1/437 | 0/215 |
| Age, Continuous(years) | Roflumilast Cream 0.05% | Vehicle Cream | Total |
|---|---|---|---|
| Mean | 3.3 ± 1.09 | 3.2 ± 1.10 | 3.3 ± 1.09 |
| Sex: Female, Male(Participants) | Roflumilast Cream 0.05% | Vehicle Cream | Total |
|---|---|---|---|
| Female | 211 | 99 | 310 |
| Male | 226 | 116 | 342 |
| Ethnicity (NIH/OMB)(Participants) | Roflumilast Cream 0.05% | Vehicle Cream | Total |
|---|---|---|---|
| Hispanic or Latino | 82 | 31 | 113 |
| Not Hispanic or Latino | 352 | 184 | 536 |
| Unknown or Not Reported | 3 | 0 | 3 |
| Race (NIH/OMB)(Participants) | Roflumilast Cream 0.05% | Vehicle Cream | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 2 | 3 |
| Asian | 37 | 17 | 54 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 68 | 32 | 100 |
| White | 295 | 156 | 451 |
| More than one race | 28 | 4 | 32 |
| Unknown or Not Reported | 8 | 4 | 12 |
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Studies of the drug tested here: Roflumilast
Arcutis Biotherapeutics, Inc. →