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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Other trials in United States

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

Other trials in Canada

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).

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 groups in NCT04845620
Study groupRoleWhat they receive
Roflumilast Cream 0.05%ExperimentalParticipants applied roflumilast cream 0.05% qd for 4 weeks.
Receives: Drug: Roflumilast Cream 0.05%
Vehicle CreamPlacebo comparatorParticipants 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.

  1. 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)

  1. 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

  2. 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

  3. 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

  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

  5. 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

  6. 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

  7. 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.

  1. First posted15 Apr 2021
  2. Study start7 Apr 2021
  3. Primary completion1 Jun 2023
  4. Study completion1 Jun 2023

Resources

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)
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
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 41795905

  • 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.

    PubMed 39980188

Questions about this trial

What is this clinical trial studying?

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.

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 5 inclusion and 6 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: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in United States, Canada. 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?

Yes. Results are posted in the registry (first posted 23 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Achievement of Validated Investigator Global Assessment for Atopic Dermatitis (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?

On the ClinicalTrials.gov record for NCT04845620, which also lists 2 linked publications.

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 23 Dec 2025.

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