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CompletedNCT04773587INTEGUMENT-IUpdated Oct 9, 2024Results posted

Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis

A Phase 3 interventional study of Roflumilast Cream 0.15% and Vehicle Cream in Atopic Dermatitis Eczema, sponsored by Arcutis Biotherapeutics, Inc.. Completed at 49 sites in 2 countries. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2024-10-09.

Sponsored by Arcutis Biotherapeutics, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
654
Allocation
Randomized
Ages
6 Years and older
Sex
All
01

Study summary

This is a parallel group, double blind, vehicle-controlled study to assess the safety and efficacy of roflumilast (ARQ-151) cream vs vehicle applied once daily (qd) for 4 weeks by participants with atopic dermatitis (eczema).

02

Conditions studied

  • Atopic Dermatitis Eczema
03

In context

Lead sponsor

Arcutis Biotherapeutics, Inc. is the lead sponsor of 25 studies on the registry; 1 is open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 20 (83%) have results posted.

Browse Arcutis Biotherapeutics, Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  1. Participants legally competent to sign and give informed consent and, if appropriate, assent as required by local laws.
  2. Males and females, ages 6 years and older at time of signing Informed Consent (Screening). Only subjects 18 years and older will be enrolled at sites located in the province of Québec in Canada.
  3. Diagnosed with atopic dermatitis 6 months duration (3 months for children), as determined by the Investigator. Stable disease for the past 4 weeks with no significant flares in atopic dermatitis before screening.
  4. Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline/Day 1. In addition, sexually active FOCBP must agree to use at least one form of a highly effective or barrier method of contraception throughout the trial.
  5. In good health as judged by the Investigator.
  6. Subjects considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.

Exclusion criteria

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 and from using a tanning bed or other artificial light emitting devices (LEDs) for 4 weeks prior to Baseline/Day 1 and during the study.
  4. Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
  5. Previous treatment with ARQ-151.
  6. Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Screening.
  7. 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.
  8. Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled subjects living in the same house.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
654 participants (actual)

Study arms

  • Experimental
    Roflumilast Cream 0.15%

    Participants with mild to moderate AD apply roflumilast cream 0.15% QD for 4 weeks.

    Drug: Roflumilast Cream 0.15%

  • Placebo comparator
    Vehicle Cream

    Participants with mild to moderate AD applied vehicle cream QD for 4 weeks.

    Drug: Vehicle Cream

Interventions

06

What researchers measure

Primary outcomes

  1. Achievement of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Success at Week 4

    The percentage of participants achieving vIGA-AD "success" is presented with multiple imputation of missing observations. vIGA-AD "success" is defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear), with higher scores indicative of greater symptom severity.

    Time frame: Week 4

Secondary outcomes

  1. Achievement of vIGA-AD Success at Week 4 in Participants With "Moderate" Baseline Scores

    The percentage of participants with moderate baseline scores achieving vIGA-AD "success" is presented with multiple imputation of missing observations. vIGA-AD "success" is defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline in participants with a 'moderate' baseline vIGA-AD score. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity.

    Time frame: Week 4

  2. Achievement of a 4-Point Reduction in the Average, Weekly Worst Itch Numeric Rating Scale (WI-NRS) at Week 4 in Participants ≥12 Years of Age With Baseline WI-NRS ≥ 4

    The percentage of participants ≥12 years of age with a baseline WI-NRS ≥4 achieving WI-NRS success at Week 4 is presented with multiple imputation of missing observations. The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the participant experienced in the previous 24 hours (higher scores indicate higher itch severity).

    Time frame: Week 4

  3. Achievement of a 4-Point Reduction in the Average, Weekly WI-NRS at Week 2 in Participants ≥12 Years of Age With Baseline WI-NRS ≥ 4

    The percentage of participants ≥12 years of age with a baseline WI-NRS ≥4 achieving WI-NRS success at Week 2 is presented with multiple imputation of missing observations. The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the participant experienced in the previous 24 hours (higher scores indicate higher itch severity).

    Time frame: Week 2

  4. Achievement of a 4-Point Reduction in the Average, Weekly WI-NRS at Week 1 in Participants ≥12 Years of Age With Baseline WI-NRS ≥ 4

    The percentage of participants ≥12 years of age with a baseline WI-NRS ≥4 achieving WI-NRS success at Week 1 is presented with multiple imputation of missing observations. The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the participant experienced in the previous 24 hours (higher scores indicate higher itch severity).

    Time frame: Week 1

  5. Achievement of ≥ 75% Reduction in the Eczema Area and Severity Index (EASI-75) at Week 4

    The percentage of participants achieving EASI-75 is presented with multiple imputation of missing observations. EASI-75 is a ≥75% reduction from the baseline EASI score. EASI combines the assessment of the severity of lesions and the area affected into a single total score in the range 0 (no disease) to 72 (maximal disease). To calculate the EASI, the sum of the severity rating (0 to 3 with 3 being the most severe) for four clinical signs are multiplied with the numerical value of the area affected and with the percentage of the four body areas.

    Time frame: Week 4

  6. Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 4

    The percentage of participants scoring 'clear' or 'almost clear' on vIGA-AD at Week 4 is presented with multiple imputation of missing observations. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity.

    Time frame: Week 4

  7. Achievement of vIGA-AD Success at Week 2

    The percentage of participants achieving "success" on the VIGA-AD at Week 2 is presented with multiple imputation of missing observations. vIGA-AD "success" is defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity.

    Time frame: Week 2

  8. Achievement of vIGA-AD Success at Week 1

    The percentage of participants achieving "success" on the VIGA-AD at Week 1 is presented with multiple imputation of missing observations. vIGA-AD "success" is defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity.

    Time frame: Week 1

  9. Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 2

    The percentage of participants scoring 'clear' or 'almost clear' on vIGA-AD at Week 4 is presented with multiple imputation of missing observations. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity.

    Time frame: Week 2

  10. Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 1

    The percentage of participants scoring 'clear' or 'almost clear' on vIGA-AD at Week 4 is presented with multiple imputation of missing observations. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity.

    Time frame: Week 1

07

Results

Posted Oct 9, 2024

Participant flow

This study was conducted at 65 centers in the United States, Canada, and Poland.

Participant flow — Overall Study
MilestoneRoflumilast Cream 0.15%Vehicle Cream
Started433221
Completed404208
Not completed2913
Withdrew: Lost to follow-up113
Withdrew: Adverse event63
Withdrew: Lack of efficacy52
Withdrew: Withdrawal by subject45
Withdrew: Noncompliance10
Withdrew: Protocol violation10
Withdrew: Consent withdrawn due to aes of nausea, headaches, dizziness, and brain fog10

Outcome measures

PrimaryAchievement of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Success at Week 4

The percentage of participants achieving vIGA-AD "success" is presented with multiple imputation of missing observations. vIGA-AD "success" is defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear), with higher scores indicative of greater symptom severity.

Time frame:
Week 4
Reported as:
Number · percentage of participants
Achievement of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Success at Week 4
percentage of participantsRoflumilast Cream 0.15%Vehicle Cream
Achievement of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Success at Week 432.0 (27.79 to 36.63)15.2 (11.06 to 20.64)
Statistical analysis
  • Roflumilast Cream 0.15% vs Vehicle Cream · Cochran-Mantel-Haenszel · p = <0.0001 · Odds ratio (or): 2.96 · 95% CI 1.881 to 4.647Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations
SecondaryAchievement of vIGA-AD Success at Week 4 in Participants With "Moderate" Baseline Scores

The percentage of participants with moderate baseline scores achieving vIGA-AD "success" is presented with multiple imputation of missing observations. vIGA-AD "success" is defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline in participants with a 'moderate' baseline vIGA-AD score. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity.

Time frame:
Week 4
Reported as:
Number · percentage of participants
Achievement of vIGA-AD Success at Week 4 in Participants With "Moderate" Baseline Scores
percentage of participantsRoflumilast Cream 0.15%Vehicle Cream
Achievement of vIGA-AD Success at Week 4 in Participants With "Moderate" Baseline Scores35.0 (29.97 to 40.36)17.5 (12.38 to 24.13)
Statistical analysis
  • Roflumilast Cream 0.15% vs Vehicle Cream · Cochran-Mantel-Haenszel · p = <0.0001 · Odds ratio (or): 2.67 · 95% CI 1.640 to 4.359Stratified by pooled study site with multiple imputation of missing observations
SecondaryAchievement of a 4-Point Reduction in the Average, Weekly Worst Itch Numeric Rating Scale (WI-NRS) at Week 4 in Participants ≥12 Years of Age With Baseline WI-NRS ≥ 4

The percentage of participants ≥12 years of age with a baseline WI-NRS ≥4 achieving WI-NRS success at Week 4 is presented with multiple imputation of missing observations. The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the participant experienced in the previous 24 hours (higher scores indicate higher itch severity).

Time frame:
Week 4
Reported as:
Number · percentage of participants
Achievement of a 4-Point Reduction in the Average, Weekly Worst Itch Numeric Rating Scale (WI-NRS) at Week 4 in Participants ≥12 Years of Age With Baseline WI-NRS ≥ 4
percentage of participantsRoflumilast Cream 0.15%Vehicle Cream
Achievement of a 4-Point Reduction in the Average, Weekly Worst Itch Numeric Rating Scale (WI-NRS) at Week 4 in Participants ≥12 Years of Age With Baseline WI-NRS ≥ 433.6 (28.19 to 39.41)20.7 (14.61 to 28.58)
Statistical analysis
  • Roflumilast Cream 0.15% vs Vehicle Cream · Cochran-Mantel-Haenszel · p = 0.0089 · Odds ratio (or): 1.98 · 95% CI 1.186 to 3.319Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations
SecondaryAchievement of a 4-Point Reduction in the Average, Weekly WI-NRS at Week 2 in Participants ≥12 Years of Age With Baseline WI-NRS ≥ 4

The percentage of participants ≥12 years of age with a baseline WI-NRS ≥4 achieving WI-NRS success at Week 2 is presented with multiple imputation of missing observations. The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the participant experienced in the previous 24 hours (higher scores indicate higher itch severity).

Time frame:
Week 2
Reported as:
Number · percentage of participants
Achievement of a 4-Point Reduction in the Average, Weekly WI-NRS at Week 2 in Participants ≥12 Years of Age With Baseline WI-NRS ≥ 4
percentage of participantsRoflumilast Cream 0.15%Vehicle Cream
Achievement of a 4-Point Reduction in the Average, Weekly WI-NRS at Week 2 in Participants ≥12 Years of Age With Baseline WI-NRS ≥ 423.8 (19.14 to 29.24)9.8 (5.79 to 16.03)
Statistical analysis
  • Roflumilast Cream 0.15% · Cochran-Mantel-Haenszel · p = 0.0016 · Odds ratio (or): 2.81 · 95% CI 1.450 to 5.457Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations
SecondaryAchievement of a 4-Point Reduction in the Average, Weekly WI-NRS at Week 1 in Participants ≥12 Years of Age With Baseline WI-NRS ≥ 4

The percentage of participants ≥12 years of age with a baseline WI-NRS ≥4 achieving WI-NRS success at Week 1 is presented with multiple imputation of missing observations. The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the participant experienced in the previous 24 hours (higher scores indicate higher itch severity).

Time frame:
Week 1
Reported as:
Number · percentage of participants
Achievement of a 4-Point Reduction in the Average, Weekly WI-NRS at Week 1 in Participants ≥12 Years of Age With Baseline WI-NRS ≥ 4
percentage of participantsRoflumilast Cream 0.15%Vehicle Cream
Achievement of a 4-Point Reduction in the Average, Weekly WI-NRS at Week 1 in Participants ≥12 Years of Age With Baseline WI-NRS ≥ 49.5 (6.60 to 13.60)2.3 (0.77 to 6.41)
Statistical analysis
  • Roflumilast Cream 0.15% vs Vehicle Cream · Cochran-Mantel-Haenszel · p = 0.0159 · Odds ratio (or): 3.81 · 95% CI 1.161 to 12.511Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations
SecondaryAchievement of ≥ 75% Reduction in the Eczema Area and Severity Index (EASI-75) at Week 4

The percentage of participants achieving EASI-75 is presented with multiple imputation of missing observations. EASI-75 is a ≥75% reduction from the baseline EASI score. EASI combines the assessment of the severity of lesions and the area affected into a single total score in the range 0 (no disease) to 72 (maximal disease). To calculate the EASI, the sum of the severity rating (0 to 3 with 3 being the most severe) for four clinical signs are multiplied with the numerical value of the area affected and with the percentage of the four body areas.

Time frame:
Week 4
Reported as:
Number · percentage of participants
Achievement of ≥ 75% Reduction in the Eczema Area and Severity Index (EASI-75) at Week 4
percentage of participantsRoflumilast Cream 0.15%Vehicle Cream
Achievement of ≥ 75% Reduction in the Eczema Area and Severity Index (EASI-75) at Week 443.2 (38.54 to 47.94)22.0 (16.97 to 28.04)
Statistical analysis
  • Roflumilast Cream 0.15% vs Vehicle Cream · Cochran-Mantel-Haenszel · p = <0.0001 · Odds ratio (or): 3.17 · 95% CI 2.102 to 4.795Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations
SecondaryAchievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 4

The percentage of participants scoring 'clear' or 'almost clear' on vIGA-AD at Week 4 is presented with multiple imputation of missing observations. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity.

Time frame:
Week 4
Reported as:
Number · percentage of participants
Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 4
percentage of participantsRoflumilast Cream 0.15%Vehicle Cream
Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 441.5 (36.93 to 46.25)25.2 (19.91 to 31.41)
Statistical analysis
  • Roflumilast Cream 0.15% vs Vehicle Cream · Cochran-Mantel-Haenszel · p = <0.0001 · Odds ratio (or): 2.56 · 95% CI 1.707 to 3.843Stratified by pooled study stie and vIGA-AD randomization strata with multiple imputation of missing observations
SecondaryAchievement of vIGA-AD Success at Week 2

The percentage of participants achieving "success" on the VIGA-AD at Week 2 is presented with multiple imputation of missing observations. vIGA-AD "success" is defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity.

Time frame:
Week 2
Reported as:
Number · percentage of participants
Achievement of vIGA-AD Success at Week 2
percentage of participantsRoflumilast Cream 0.15%Vehicle Cream
Achievement of vIGA-AD Success at Week 221.2 (17.57 to 25.33)6.4 (3.84 to 10.44)
Statistical analysis
  • Roflumilast Cream 0.15% vs Vehicle Cream · Cochran-Mantel-Haenszel · p = <0.0001 · Odds ratio (or): 4.28 · 95% CI 2.310 to 7.926Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations
SecondaryAchievement of vIGA-AD Success at Week 1

The percentage of participants achieving "success" on the VIGA-AD at Week 1 is presented with multiple imputation of missing observations. vIGA-AD "success" is defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity.

Time frame:
Week 1
Reported as:
Number · percentage of participants
Achievement of vIGA-AD Success at Week 1
percentage of participantsRoflumilast Cream 0.15%Vehicle Cream
Achievement of vIGA-AD Success at Week 18.1 (5.87 to 11.03)0.5 (0.08 to 2.52)
Statistical analysis
  • Roflumilast Cream 0.15% vs Vehicle Cream · Cochran-Mantel-Haenszel · p = <0.0001 · Odds ratio (or): 25.41 · 95% CI 2.815 to 229.388Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations
SecondaryAchievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 2

The percentage of participants scoring 'clear' or 'almost clear' on vIGA-AD at Week 4 is presented with multiple imputation of missing observations. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity.

Time frame:
Week 2
Reported as:
Number · percentage of participants
Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 2
percentage of participantsRoflumilast Cream 0.15%Vehicle Cream
Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 231.8 (27.58 to 36.38)13.6 (9.72 to 18.79)
Statistical analysis
  • Roflumilast Cream 0.15% vs Vehicle Cream · Cochran-Mantel-Haenszel · p = <0.0001 · Odds ratio (or): 3.62 · 95% CI 2.217 to 5.911Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations
SecondaryAchievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 1

The percentage of participants scoring 'clear' or 'almost clear' on vIGA-AD at Week 4 is presented with multiple imputation of missing observations. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity.

Time frame:
Week 1
Reported as:
Number · percentage of participants
Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 1
percentage of participantsRoflumilast Cream 0.15%Vehicle Cream
Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 114.3 (11.33 to 17.93)5.9 (3.47 to 9.80)
Statistical analysis
  • Roflumilast Cream 0.15% vs Vehicle Cream · Cochran-Mantel-Haenszel · p = 0.0002 · Odds ratio (or): 3.46 · 95% CI 1.705 to 7.007Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations

Adverse events

Collected over Up to approximately 29 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Roflumilast Cream 0.15%0/433 (0%)4/433 (0.9%)0/433 (0%)
Vehicle Cream0/221 (0%)0/221 (0%)0/221 (0%)
Most frequent serious events
Most frequent serious events
EventRoflumilast Cream 0.15%Vehicle Cream
DiverticulitisInfections and infestations1/4330/221
DepressionPsychiatric disorders1/4330/221
Suicidal ideationPsychiatric disorders1/4330/221
Pulmonary embolismVascular disorders1/4330/221

Baseline characteristics

Age, Continuous
Age, Continuous(years)Roflumilast Cream 0.15%Vehicle CreamTotal
Mean28.1 ± 19.1428.5 ± 18.9428.2 ± 19.06
Sex: Female, Male
Sex: Female, Male(Participants)Roflumilast Cream 0.15%Vehicle CreamTotal
Female237129366
Male19692288
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Roflumilast Cream 0.15%Vehicle CreamTotal
Hispanic or Latino9956155
Not Hispanic or Latino333164497
Unknown or Not Reported112
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Roflumilast Cream 0.15%Vehicle CreamTotal
White261129390
American Indian or Alaska native202
Asian633295
Native Hawaiian or other Pacific Islander101
Black or African American8046126
Multiple12618
Other14822
Randomization validated Investigator's Global Assessment Scale for Atopic Dermatitis (vIGA-AD)
Randomization validated Investigator's Global Assessment Scale for Atopic Dermatitis (vIGA-AD)(Participants)Roflumilast Cream 0.15%Vehicle CreamTotal
2 - Mild10557162
3 - Moderate328164492
Verified vIGA-AD
Verified vIGA-AD(Participants)Roflumilast Cream 0.15%Vehicle CreamTotal
Mild10359162
Moderate330162492
08

Study locations

49 sites
  • Arcutis Clinical Site 57
    Montgomery, Alabama 36117, United States
  • Arcutis Clinical Site 34
    Scottsdale, Arizona 85255, United States
  • Arcutis Clinical Site 58
    Little Rock, Arkansas 72212, United States
  • Arcutis Clinical Site 40
    Beverly Hills, California 90212, United States
  • Arcutis Clinical Site 06
    Encinitas, California 92024, United States
  • Arcutis Clinical Site 52
    Los Angeles, California 90056, United States
  • Arcutis Clinical Site 05
    San Diego, California 92123, United States
  • Arcutis Clinical Site 08
    San Francisco, California 94132, United States
  • Arcutis Clinical Site 62
    Thousand Oaks, California 91320, United States
  • Arcutis Clinical Site 30
    Coral Gables, Florida 33134, United States
  • Arcutis Clinical Site 04
    Jacksonville, Florida 32256, United States
  • Arcutis Clinical Site 15
    Largo, Florida 33770, United States
  • Arcutis Clinical Site 39
    Miami Lakes, Florida 33014, United States
  • Arcutis Clinical Site 38
    North Miami Beach, Florida 33162, United States
  • Arcutis Clinical Site 01
    Tampa, Florida 33613, United States
  • Arcutis Clinical Site 61
    Wellington, Florida 33449, United States
  • Arcutis Clinical Site 26
    Sandy Springs, Georgia 30328, United States
  • Arcutis Clinical Site 13
    Rolling Meadows, Illinois 33770, United States
  • Arcutis Clinical Site 48
    Clarksville, Indiana 47129, United States
  • Arcutis Clinical Site 02
    Indianapolis, Indiana 46250, United States
  • Arcutis Clinical Site 03
    Louisville, Kentucky 40217, United States
  • Arcutis Clinical Site 36
    Rockville, Maryland 20850, United States
  • Arcutis Clinical Site 55
    Auburn Hills, Michigan 48326, United States
  • Arcutis Clinical Site 54
    Bay City, Michigan 48706, United States
  • Arcutis Clinical Site 46
    Clarkston, Michigan 48346, United States
  • Arcutis Clinical Site 37
    Detroit, Michigan 48202, United States
  • Arcutis Clinical Site 10
    New Brighton, Minnesota 55112, United States
  • Arcutis Clinical Site 33
    Reno, Nevada 89509, United States
  • Arcutis Clinical Site 42
    East Windsor, New Jersey 08520, United States
  • Arcutis Clinical Site 17
    Gresham, Oregon 97030, United States
  • Arcutis Clinical Site 16
    Portland, Oregon 97223, United States
  • Arcutis Clinical Site 14
    Portland, Oregon 97239, United States
  • Arcutis Clinical Site 35
    Newtown Square, Pennsylvania 19073, United States
  • Arcutis Clinical Site 101
    Johnston, Rhode Island 02919, United States
  • Arcutis Clinical Site 31
    Murfreesboro, Tennessee 37130, United States
  • Arcutis Clinical Site 19
    Arlington, Texas 76011, United States
  • Arcutis Clinical Site 43
    Bellaire, Texas 77401, United States
  • Arcutis Clinical Site 27
    Houston, Texas 77030, United States
  • Arcutis Clinical Site 20
    Houston, Texas 77056, United States
  • Arcutis Clinical Site 28
    San Antonio, Texas 78218, United States
  • Arcutis Clinical Site 21
    South Jordan, Utah 84095, United States
  • Arcutis Clinical Site 12
    Spokane, Washington 99202, United States
  • Arcutis Clinical Site 41
    Calgary, Alberta T2J 7E1, Canada
  • Arcutis Clinical Site 29
    Fredericton, New Brunswick E3B 1G9, Canada
  • Arcutis Clinical Site 11
    Markham, Ontario L3P 1X3, Canada
  • Clinical Site 25
    Mississauga, Ontario L5H 1G9, Canada
  • Arcutis Clinical Site 32
    Peterborough, Ontario K9J 5K2, Canada
  • Arcutis Clinical Site 09
    Windsor, Ontario N8W 1E6, Canada
  • Arcutis Clinical Site 24
    Montreal, Quebec H2X 2V1, Canada
09

References and documents

Publications

  • Simpson EL, Eichenfield LF, Alonso-Llamazares J, Draelos ZD, Ferris LK, Forman SB, Gooderham M, Gonzalez ME, Hebert AA, Kircik LH, Lomaga M, Moore A, Papp KA, Prajapati VH, Hanna D, Snyder S, Krupa D, Burnett P, Almaraz E, Higham RC, Chu DH, Berk DR. Roflumilast Cream, 0.15%, for Atopic Dermatitis in Adults and Children: INTEGUMENT-1 and INTEGUMENT-2 Randomized Clinical Trials. JAMA Dermatol. 2024 Nov 1;160(11):1161-1170. doi: 10.1001/jamadermatol.2024.3121. PubMed 39292443 ↗

Study documents

  • Study protocol · Oct 19, 2020
  • Statistical analysis plan · Oct 25, 2022

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04773587
Lead sponsor
Arcutis Biotherapeutics, Inc.
Responsible party
Sponsor
First posted
Feb 26, 2021
Start date
Jan 27, 2021
Primary completion
Aug 30, 2022
Completion
Aug 30, 2022
Results posted
Oct 9, 2024
Last update
Oct 9, 2024

Study contacts

David Berk, MD
study director · Arcutis Biotherapeutics, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Roflumilast

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