Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED)

December 8, 2025 updated by: Arcutis Biotherapeutics, Inc.

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a parallel group, double blind, vehicle-controlled study in which ARQ-151 cream or vehicle is applied once daily for 4 weeks to subjects with atopic dermatitis.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
652

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2J 7E1
        • Arcutis Clinical Site 29
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3C 0N2
        • Arcutis Clinical Site 64
    • Ontario
      • Burlington, Ontario, Canada, L7L 6W6
        • Arcutis Clinical Site 73
      • Markham, Ontario, Canada, L3P 1X3
        • Arcutis Clinical Site 36
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 2C1
        • Arcutis Clinical Site 78
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Arcutis Clinical Site 56
      • Birmingham, Alabama, United States, 35244
        • Arcutis Clinical Site 14
      • Montgomery, Alabama, United States, 36117
        • Arcutis Clinical Site 69
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Arcutis Clinical Site 68
      • Scottsdale, Arizona, United States, 85255
        • Arcutis Clinical Site 26
    • Arkansas
      • Bryant, Arkansas, United States, 72022
        • Arcutis Clinical Site 50
      • Fort Smith, Arkansas, United States, 72916
        • Arcutis Clinical Site 59
      • Little Rock, Arkansas, United States, 72212
        • Arcutis Clinical Site 71
    • California
      • Inglewood, California, United States, 90301
        • Arcutis Clinical Site 09
      • Rancho Santa Margarita, California, United States, 92688
        • Arcutis Clinical Site 45
      • San Diego, California, United States, 92123
        • Arcutis Clinical Site 30
      • Thousand Oaks, California, United States, 91320
        • Arcutis Clinical Site 70
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Arcutis Clinical Site 48
      • Coral Gables, Florida, United States, 33134
        • Arcutis Clinical Site 33
      • Coral Gables, Florida, United States, 33146
        • Arcutis Clinical Site 12
      • Delray Beach, Florida, United States, 33484
        • Arcutis Clinical Site 11
      • Largo, Florida, United States, 33770
        • Arcutis Clinical Site 28
      • Miami, Florida, United States, 33137
        • Arcutis Clinical Site 79
      • Miami, Florida, United States, 33173
        • Arcutis Clinical Site 43
      • Miami Lakes, Florida, United States, 33014
        • Arcutis Clinical Site 10
      • North Miami Beach, Florida, United States, 33162
        • Arcutis Clinical Site 35
      • Wellington, Florida, United States, 33449
        • Arcutis Clinical Site 75
    • Georgia
      • Sandy Springs, Georgia, United States, 30328
        • Arcutis Clinical Site 20
    • Idaho
      • Boise, Idaho, United States, 83706
        • Arcutis Clinical Site 82
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Arcutis Clinical Site 60
      • Rolling Meadows, Illinois, United States, 33770
        • Arcutis Clinical Site 07
    • Indiana
      • Clarksville, Indiana, United States, 47129
        • Arcutis Clinical Site 42
      • Plainfield, Indiana, United States, 46168
        • Arcutis Clinical Site 21
      • West Lafayette, Indiana, United States, 47906
        • Arcutis Clinical Site 57
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • Arcutis Clinical Site 22
      • Louisville, Kentucky, United States, 40241
        • Arcutis Clinical Site 46
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Arcutis Clinical Site 84
      • Lake Charles, Louisiana, United States, 70605
        • Arcutis Clinical Site 34
      • Metairie, Louisiana, United States, 70005
        • Arcutis Clinical Site 51
      • Metairie, Louisiana, United States, 70006
        • Arcutis Clinical Site 40
    • Maryland
      • Columbia, Maryland, United States, 21045
        • Arcutis Clinical Site 77
      • Rockville, Maryland, United States, 20850
        • Arcutis Clinical Site 13
      • Rockville, Maryland, United States, 20850
        • Arcutis Clinical Site 15
    • Michigan
      • Auburn Hills, Michigan, United States, 48326
        • Arcutis Clinical Site 53
      • Bay City, Michigan, United States, 48706
        • Arcutis Clinical Site 41
      • Clarkston, Michigan, United States, 48346
        • Arcutis Clinical Site 36
      • Troy, Michigan, United States, 48084
        • Arcutis Clinical Site 72
    • Minnesota
      • New Brighton, Minnesota, United States, 55112
        • Arcutis Clinical Site 05
    • Missouri
      • Saint Joseph, Missouri, United States, 64506
        • Arcutis Clinical Site 47
    • Nevada
      • Reno, Nevada, United States, 89509
        • Arcutis Clinical Site 16
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Arcutis Clinical Site 55
    • New York
      • Brooklyn, New York, United States, 11203
        • Arcutis Clinical Site 54
      • New York, New York, United States, 11415
        • Arcutis Clinical Site 44
      • Rochester, New York, United States, 14623
        • Arcutis Clinical Site 32
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Arcutis Clinical Site 58
      • Mason, Ohio, United States, 45040
        • Arcutis Clinical Site 81
    • Oregon
      • Gresham, Oregon, United States, 97030
        • Arcutis Clinical Site 01
      • Portland, Oregon, United States, 97210
        • Arcutis Clinical Site 52
      • Portland, Oregon, United States, 97239
        • Arcutis Clinical Site 63
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18105
        • Arcutis Clinical Site 65
      • Hershey, Pennsylvania, United States, 17033
        • Arcutis Clinical Site 31
      • Newtown Square, Pennsylvania, United States, 19073
        • Arcutis Clinical Site 24
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Arcutis Clinical Site 62
      • Summerville, South Carolina, United States, 29486
        • Arcutis Clinical Site 39
    • Texas
      • Austin, Texas, United States, 78759
        • Arcutis Clinical Site 08
      • Bellaire, Texas, United States, 77401
        • Arcutis Clinical Site 27
      • Fort Worth, Texas, United States, 76244
        • Arcutis Clinical Site 74
      • Frisco, Texas, United States, 75034
        • Arcutis Clinical Site 66
      • Grapevine, Texas, United States, 76051
        • Arcutis Clinical Site 61
      • Houston, Texas, United States, 77030
        • Arcutis Clinical Site 04
      • San Antonio, Texas, United States, 78213
        • Arcutis Clinical Site 02
      • San Antonio, Texas, United States, 78218
        • Arcutis Clinical Site 18
    • Utah
      • South Jordan, Utah, United States, 84095
        • Arcutis Clinical Site 03
    • Virginia
      • Burke, Virginia, United States, 22015
        • Arcutis Clinical Site 06
      • Charlottesville, Virginia, United States, 22902
        • Arcutis Clinical Site 76
    • Washington
      • Spokane, Washington, United States, 99202
        • Arcutis Clinical Site 25

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 5 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Informed consent by parent(s) or legal guardian as required by local laws.
  2. Males and females, ages 2 to 5 years old at time of signing Informed Consent (Screening) and at Baseline (Day 1).
  3. 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.
  4. In good health as judged by the Investigator.
  5. Subjects considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.

Exclusion Criteria:

  1. 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
  2. Has unstable AD or any consistent requirement for high potency topical steroids.
  3. Subjects who are unwilling to refrain from prolonged sun exposure for 4 weeks prior to Baseline/Day 1 and during the study.
  4. Previous treatment with ARQ-151.
  5. 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.
  6. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Roflumilast Cream 0.05%
Participants applied roflumilast cream 0.05% qd for 4 weeks.
Drug: Roflumilast Cream 0.05%
Roflumilast cream for topical application.
Other Names:
  • ARQ-151
Placebo Comparator: Vehicle Cream
Participants applied vehicle cream qd for 4 weeks.
Drug: Vehicle Cream
Vehicle cream matched to roflumilast cream for topical application.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Achievement of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Success at Week 4
Time Frame: 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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Achievement of vIGA-AD Success at Week 4 in Participants With 'Moderate' Baseline vIGA-AD
Time Frame: Week 4
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.
Week 4
Achievement of 75% Reduction in the Eczema Area and Severity Index (EASI-75) at Week 4 In Participants With 'Moderate' Baseline vIGA
Time Frame: Week 4
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'
Time Frame: Week 4
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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Arcutis Biotherapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: David Berk, MD, Arcutis Biotherapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 7, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 15, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ARQ-151-315

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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