Atopic Dermatitis EczemaPhase 3NCT04845620
Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED)
A Phase 3 study testing Roflumilast Cream 0.05% in people with Atopic Dermatitis Eczema, run by Arcutis Biotherapeutics, Inc. at 76 sites in 2 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Atopic Dermatitis Eczema
- What is being tested?
- Roflumilast Cream 0.05%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 652 participants
- Where
- 76 sitesin 2 countries
- Study dates
- 7 Apr 2021to 1 Jun 2023
- Phase
- Phase 3
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 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Informed consent by parent(s) or legal guardian as required by local laws.
- Males and females, ages 2 to 5 years old at time of signing Informed Consent (Screening) and at Baseline (Day 1).
- Diagnosed with atopic dermatitis for at least 6 weeks, as determined by the Investigator. Stable disease for the past 4 weeks with no significant flares in atopic dermatitis before screening.
- In good health as judged by the Investigator.
- Subjects considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.
Who cannot join
- Subjects with any serious medical condition or clinically significant abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator
- Has unstable AD or any consistent requirement for high potency topical steroids.
- Subjects who are unwilling to refrain from prolonged sun exposure for 4 weeks prior to Baseline/Day 1 and during the study.
- Previous treatment with ARQ-151.
- Parent(s)/legal guardian(s) who are unable to communicate, read, or understand the local language(s). Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation.
- Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled (in other studies of ARQ-151) subjects living in the same house.
Trial locations and contacts
76 sites in 2 countries.
76 sites in 2 countries
United States71 sites
Arcutis Clinical Site 53
Auburn Hills, Michigan, 48326
Arcutis Clinical Site 08
Austin, Texas, 78759
Arcutis Clinical Site 84
Baton Rouge, Louisiana, 70808
Arcutis Clinical Site 41
Bay City, Michigan, 48706
Arcutis Clinical Site 27
Bellaire, Texas, 77401
Arcutis Clinical Site 65
Bethlehem, Pennsylvania, 18105
Arcutis Clinical Site 56
Birmingham, Alabama, 35209
Arcutis Clinical Site 14
Birmingham, Alabama, 35244
Arcutis Clinical Site 48
Boca Raton, Florida, 33486
Arcutis Clinical Site 82
Boise, Idaho, 83706
Arcutis Clinical Site 54
Brooklyn, New York, 11203
Arcutis Clinical Site 50
Bryant, Arkansas, 72022
Arcutis Clinical Site 06
Burke, Virginia, 22015
Arcutis Clinical Site 62
Charleston, South Carolina, 29425
Arcutis Clinical Site 76
Charlottesville, Virginia, 22902
Arcutis Clinical Site 60
Chicago, Illinois, 60607
Arcutis Clinical Site 58
Cincinnati, Ohio, 45229
Arcutis Clinical Site 36
Clarkston, Michigan, 48346
Arcutis Clinical Site 42
Clarksville, Indiana, 47129
Arcutis Clinical Site 77
Columbia, Maryland, 21045
Arcutis Clinical Site 33
Coral Gables, Florida, 33134
Arcutis Clinical Site 12
Coral Gables, Florida, 33146
Arcutis Clinical Site 11
Delray Beach, Florida, 33484
Arcutis Clinical Site 59
Fort Smith, Arkansas, 72916
Arcutis Clinical Site 74
Fort Worth, Texas, 76244
Arcutis Clinical Site 66
Frisco, Texas, 75034
Arcutis Clinical Site 68
Gilbert, Arizona, 85234
Arcutis Clinical Site 61
Grapevine, Texas, 76051
Arcutis Clinical Site 01
Gresham, Oregon, 97030
Arcutis Clinical Site 31
Hershey, Pennsylvania, 17033
Arcutis Clinical Site 04
Houston, Texas, 77030
Arcutis Clinical Site 09
Inglewood, California, 90301
Arcutis Clinical Site 34
Lake Charles, Louisiana, 70605
Arcutis Clinical Site 28
Largo, Florida, 33770
Arcutis Clinical Site 55
Lebanon, New Hampshire, 03756
Arcutis Clinical Site 71
Little Rock, Arkansas, 72212
Arcutis Clinical Site 22
Louisville, Kentucky, 40217
Arcutis Clinical Site 46
Louisville, Kentucky, 40241
Arcutis Clinical Site 81
Mason, Ohio, 45040
Arcutis Clinical Site 51
Metairie, Louisiana, 70005
Arcutis Clinical Site 40
Metairie, Louisiana, 70006
Arcutis Clinical Site 79
Miami, Florida, 33137
Arcutis Clinical Site 43
Miami, Florida, 33173
Arcutis Clinical Site 10
Miami Lakes, Florida, 33014
Arcutis Clinical Site 69
Montgomery, Alabama, 36117
Arcutis Clinical Site 05
New Brighton, Minnesota, 55112
Arcutis Clinical Site 44
New York, New York, 11415
Arcutis Clinical Site 24
Newtown Square, Pennsylvania, 19073
Arcutis Clinical Site 35
North Miami Beach, Florida, 33162
Arcutis Clinical Site 21
Plainfield, Indiana, 46168
Arcutis Clinical Site 52
Portland, Oregon, 97210
Arcutis Clinical Site 63
Portland, Oregon, 97239
Arcutis Clinical Site 45
Rancho Santa Margarita, California, 92688
Arcutis Clinical Site 16
Reno, Nevada, 89509
Arcutis Clinical Site 32
Rochester, New York, 14623
Arcutis Clinical Site 13
Rockville, Maryland, 20850
Arcutis Clinical Site 15
Rockville, Maryland, 20850
Arcutis Clinical Site 07
Rolling Meadows, Illinois, 33770
Arcutis Clinical Site 47
Saint Joseph, Missouri, 64506
Arcutis Clinical Site 02
San Antonio, Texas, 78213
Arcutis Clinical Site 18
San Antonio, Texas, 78218
Arcutis Clinical Site 30
San Diego, California, 92123
Arcutis Clinical Site 20
Sandy Springs, Georgia, 30328
Arcutis Clinical Site 26
Scottsdale, Arizona, 85255
Arcutis Clinical Site 03
South Jordan, Utah, 84095
Arcutis Clinical Site 25
Spokane, Washington, 99202
Arcutis Clinical Site 39
Summerville, South Carolina, 29486
Arcutis Clinical Site 70
Thousand Oaks, California, 91320
Arcutis Clinical Site 72
Troy, Michigan, 48084
Arcutis Clinical Site 75
Wellington, Florida, 33449
Arcutis Clinical Site 57
West Lafayette, Indiana, 47906
Canada5 sites
Arcutis Clinical Site 73
Burlington, Ontario, L7L 6W6
Arcutis Clinical Site 29
Calgary, Alberta, T2J 7E1
Arcutis Clinical Site 36
Markham, Ontario, L3P 1X3
Arcutis Clinical Site 78
Saskatoon, Saskatchewan, S7K 2C1
Arcutis Clinical Site 64
Winnipeg, Manitoba, R3C 0N2
About this study
Official title: A Phase 3, 4-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.05% Administered QD in Subjects With Atopic Dermatitis
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).
- Conditions
- Atopic Dermatitis Eczema
- Being tested
- Roflumilast Cream 0.05%, Vehicle Cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roflumilast Cream 0.05%Drug
Also called ARQ-151
Roflumilast cream for topical application.
Vehicle CreamDrug
Vehicle cream matched to roflumilast cream for topical application.
| Study group | Role | What they receive |
|---|---|---|
| Roflumilast Cream 0.05% | Experimental | Participants applied roflumilast cream 0.05% qd for 4 weeks. Receives: Drug: Roflumilast Cream 0.05% |
| Vehicle Cream | Placebo comparator | Participants applied vehicle cream qd for 4 weeks. Receives: Drug: Vehicle Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 4
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start7 Apr 2021
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atopic Dermatitis EczemaStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 652 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arcutis Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Berk, MD, Study director, Arcutis Biotherapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845620
- Sponsor's protocol ID
- ARQ-151-315
- Status last verified
- Dec 2025
- First submitted
- 11 Apr 2021
- Last updated
- 23 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 41795905Eichenfield 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.
PubMed 39980188