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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Roflumilast Cream 0.05% | Experimental | Participants applied roflumilast cream 0.05% qd for 4 weeks. |
|
| Vehicle Cream | Placebo Comparator | Participants applied vehicle cream qd for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roflumilast Cream 0.05% | Drug | Roflumilast cream for topical application. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Berk, MD | Arcutis Biotherapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arcutis Clinical Site 56 | Birmingham | Alabama | 35209 | United States | ||
| Arcutis Clinical Site 14 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41795905 | Derived | Eichenfield LF, Gonzalez ME, Boguniewicz M, Funk T, Hebert AA, Prajapati VH, Kindred C, Serrao R, Swanson L, Krupa D, Snyder S, Seal MS, Hanna D, Burnett P, Berk DR. Long-Term Safety and Efficacy of Once-Daily and Proactive Twice-Weekly Roflumilast Cream 0.05% for Mild-to-Moderate Atopic Dermatitis in Children Aged 2-5 Years From a 52-Week, Phase 3 Trial (INTEGUMENT-OLE). Pediatr Dermatol. 2026 May-Jun;43(3):642-649. doi: 10.1111/pde.70177. Epub 2026 Mar 8. | |
| 39980188 |
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This study was conducted at 109 centers in the United States, Canada, and Poland.
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| ID | Title | Description |
|---|---|---|
| FG000 | Roflumilast Cream 0.05% | Participants applied roflumilast cream 0.05% qd for 4 weeks. |
| FG001 | Vehicle Cream | Participants applied vehicle cream qd for 4 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 10, 2023 | Nov 3, 2025 |
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| Vehicle Cream | Drug | Vehicle cream matched to roflumilast cream for topical application. |
|
| 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. | 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. | 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. | 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. | 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. | 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. | Week 1 |
| Birmingham |
| Alabama |
| 35244 |
| United States |
| Arcutis Clinical Site 69 | Montgomery | Alabama | 36117 | United States |
| Arcutis Clinical Site 68 | Gilbert | Arizona | 85234 | United States |
| Arcutis Clinical Site 26 | Scottsdale | Arizona | 85255 | United States |
| Arcutis Clinical Site 50 | Bryant | Arkansas | 72022 | United States |
| Arcutis Clinical Site 59 | Fort Smith | Arkansas | 72916 | United States |
| Arcutis Clinical Site 71 | Little Rock | Arkansas | 72212 | United States |
| Arcutis Clinical Site 09 | Inglewood | California | 90301 | United States |
| Arcutis Clinical Site 45 | Rancho Santa Margarita | California | 92688 | United States |
| Arcutis Clinical Site 30 | San Diego | California | 92123 | United States |
| Arcutis Clinical Site 70 | Thousand Oaks | California | 91320 | United States |
| Arcutis Clinical Site 48 | Boca Raton | Florida | 33486 | United States |
| Arcutis Clinical Site 33 | Coral Gables | Florida | 33134 | United States |
| Arcutis Clinical Site 12 | Coral Gables | Florida | 33146 | United States |
| Arcutis Clinical Site 11 | Delray Beach | Florida | 33484 | United States |
| Arcutis Clinical Site 28 | Largo | Florida | 33770 | United States |
| Arcutis Clinical Site 79 | Miami | Florida | 33137 | United States |
| Arcutis Clinical Site 43 | Miami | Florida | 33173 | United States |
| Arcutis Clinical Site 10 | Miami Lakes | Florida | 33014 | United States |
| Arcutis Clinical Site 35 | North Miami Beach | Florida | 33162 | United States |
| Arcutis Clinical Site 75 | Wellington | Florida | 33449 | United States |
| Arcutis Clinical Site 20 | Sandy Springs | Georgia | 30328 | United States |
| Arcutis Clinical Site 82 | Boise | Idaho | 83706 | United States |
| Arcutis Clinical Site 60 | Chicago | Illinois | 60607 | United States |
| Arcutis Clinical Site 07 | Rolling Meadows | Illinois | 33770 | United States |
| Arcutis Clinical Site 42 | Clarksville | Indiana | 47129 | United States |
| Arcutis Clinical Site 21 | Plainfield | Indiana | 46168 | United States |
| Arcutis Clinical Site 57 | West Lafayette | Indiana | 47906 | United States |
| Arcutis Clinical Site 22 | Louisville | Kentucky | 40217 | United States |
| Arcutis Clinical Site 46 | Louisville | Kentucky | 40241 | United States |
| Arcutis Clinical Site 84 | Baton Rouge | Louisiana | 70808 | United States |
| Arcutis Clinical Site 34 | Lake Charles | Louisiana | 70605 | United States |
| Arcutis Clinical Site 51 | Metairie | Louisiana | 70005 | United States |
| Arcutis Clinical Site 40 | Metairie | Louisiana | 70006 | United States |
| Arcutis Clinical Site 77 | Columbia | Maryland | 21045 | United States |
| Arcutis Clinical Site 13 | Rockville | Maryland | 20850 | United States |
| Arcutis Clinical Site 15 | Rockville | Maryland | 20850 | United States |
| Arcutis Clinical Site 53 | Auburn Hills | Michigan | 48326 | United States |
| Arcutis Clinical Site 41 | Bay City | Michigan | 48706 | United States |
| Arcutis Clinical Site 36 | Clarkston | Michigan | 48346 | United States |
| Arcutis Clinical Site 72 | Troy | Michigan | 48084 | United States |
| Arcutis Clinical Site 05 | New Brighton | Minnesota | 55112 | United States |
| Arcutis Clinical Site 47 | Saint Joseph | Missouri | 64506 | United States |
| Arcutis Clinical Site 16 | Reno | Nevada | 89509 | United States |
| Arcutis Clinical Site 55 | Lebanon | New Hampshire | 03756 | United States |
| Arcutis Clinical Site 54 | Brooklyn | New York | 11203 | United States |
| Arcutis Clinical Site 44 | New York | New York | 11415 | United States |
| Arcutis Clinical Site 32 | Rochester | New York | 14623 | United States |
| Arcutis Clinical Site 58 | Cincinnati | Ohio | 45229 | United States |
| Arcutis Clinical Site 81 | Mason | Ohio | 45040 | United States |
| Arcutis Clinical Site 01 | Gresham | Oregon | 97030 | United States |
| Arcutis Clinical Site 52 | Portland | Oregon | 97210 | United States |
| Arcutis Clinical Site 63 | Portland | Oregon | 97239 | United States |
| Arcutis Clinical Site 65 | Bethlehem | Pennsylvania | 18105 | United States |
| Arcutis Clinical Site 31 | Hershey | Pennsylvania | 17033 | United States |
| Arcutis Clinical Site 24 | Newtown Square | Pennsylvania | 19073 | United States |
| Arcutis Clinical Site 62 | Charleston | South Carolina | 29425 | United States |
| Arcutis Clinical Site 39 | Summerville | South Carolina | 29486 | United States |
| Arcutis Clinical Site 08 | Austin | Texas | 78759 | United States |
| Arcutis Clinical Site 27 | Bellaire | Texas | 77401 | United States |
| Arcutis Clinical Site 74 | Fort Worth | Texas | 76244 | United States |
| Arcutis Clinical Site 66 | Frisco | Texas | 75034 | United States |
| Arcutis Clinical Site 61 | Grapevine | Texas | 76051 | United States |
| Arcutis Clinical Site 04 | Houston | Texas | 77030 | United States |
| Arcutis Clinical Site 02 | San Antonio | Texas | 78213 | United States |
| Arcutis Clinical Site 18 | San Antonio | Texas | 78218 | United States |
| Arcutis Clinical Site 03 | South Jordan | Utah | 84095 | United States |
| Arcutis Clinical Site 06 | Burke | Virginia | 22015 | United States |
| Arcutis Clinical Site 76 | Charlottesville | Virginia | 22902 | United States |
| Arcutis Clinical Site 25 | Spokane | Washington | 99202 | United States |
| Arcutis Clinical Site 29 | Calgary | Alberta | T2J 7E1 | Canada |
| Arcutis Clinical Site 64 | Winnipeg | Manitoba | R3C 0N2 | Canada |
| Arcutis Clinical Site 73 | Burlington | Ontario | L7L 6W6 | Canada |
| Arcutis Clinical Site 36 | Markham | Ontario | L3P 1X3 | Canada |
| Arcutis Clinical Site 78 | Saskatoon | Saskatchewan | S7K 2C1 | Canada |
| Derived |
| Eichenfield LF, Serrao R, Prajapati VH, Browning JC, Swanson L, Funk T, Gonzalez ME, Hebert AA, Lee M, Boguniewicz M, Simpson EL, Seal MS, Krupa D, Hanna D, Snyder S, Burnett P, Chu DH, Almaraz E, Higham RC, Berk DR. Efficacy and Safety of Once-Daily Roflumilast Cream 0.05% in Pediatric Patients Aged 2-5 Years With Mild-to-Moderate Atopic Dermatitis (INTEGUMENT-PED): A Phase 3 Randomized Controlled Trial. Pediatr Dermatol. 2025 Mar-Apr;42(2):296-304. doi: 10.1111/pde.15840. Epub 2025 Feb 20. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Roflumilast Cream 0.05% | Participants applied roflumilast cream 0.05% qd for 4 weeks. |
| BG001 | Vehicle Cream | Participants applied vehicle cream qd for 4 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All randomized participants are included, 1 participant in the Roflumilast Cream 0.05% arm was inadvertently treated prior to randomization and thus excluded from analysis. | Posted | Number | 97.5% Confidence Interval | percentage of participants | Week 4 |
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| Secondary | 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. | All randomized participants with a baseline vIGA score of 'moderate' are included. | Posted | Number | 97.5% Confidence Interval | percentage of participants | Week 4 |
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| Secondary | 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. | All randomized participants are included, with the exception of 1 participant in the Roflumilast Cream 0.05% arm who was inadvertently treated prior to randomization and thus excluded from analysis. | Posted | Number | 97.5% Confidence Interval | percentage of participants | Week 4 |
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| Secondary | 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. | All randomized participants are included, 1 participant in the Roflumilast Cream 0.05% arm was inadvertently treated prior to randomization and thus excluded from analysis. | Posted | Number | 97.5% Confidence Interval | percentage of participants | Week 4 |
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| Secondary | 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. | All randomized participants are included, 1 participant in the Roflumilast Cream 0.05% arm was inadvertently treated prior to randomization and thus excluded from analysis. | Posted | Number | 97.5% Confidence Interval | percentage of participants | Week 2 |
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| Secondary | 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. | All randomized participants are included, 1 participant in the Roflumilast Cream 0.05% arm was inadvertently treated prior to randomization and thus excluded from analysis. | Posted | Number | 97.5% Confidence Interval | percentage of participants | Week 1 |
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| Secondary | 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. | All randomized participants are included, 1 participant in the Roflumilast Cream 0.05% arm was inadvertently treated prior to randomization and thus excluded from analysis. | Posted | Number | 97.5% Confidence Interval | percentage of participants | Week 2 |
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| Secondary | 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. | All randomized participants are included, 1 participant in the Roflumilast Cream 0.05% arm was inadvertently treated prior to randomization and thus excluded from analysis. | Posted | Number | 97.5% Confidence Interval | percentage of participants | Week 1 |
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Up to ~6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Roflumilast Cream 0.05% | Participants applied roflumilast cream 0.05% qd for 4 weeks. | 0 | 437 | 1 | 437 | 0 | 437 |
| EG001 | Vehicle Cream | Participants applied vehicle cream qd for 4 weeks. | 0 | 215 | 0 | 215 | 0 | 215 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
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The process of coordinating publication efforts is detailed in the Clinical Trial Agreement.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arcutis Medical Information | Arcutis Biotherapeutics | +1 (844) 692-6729 | medinfo@arcutis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 12, 2023 | Nov 3, 2025 | SAP_001.pdf |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Units | Counts |
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