Trial · NCT04773600
Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-II)
NCT04773600, Phase 3, Completed, Arcutis Biotherapeutics, Inc.; results first posted 2024-10-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-II). Trials, record NCT04773600. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04773600
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-II)
- NCT number
- NCT04773600
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 683 participants, actual
- Lead sponsor
- Arcutis Biotherapeutics, Inc.
- Conditions
- Atopic Dermatitis Eczema
- Interventions
- Roflumilast Cream, Vehicle cream
- First posted
- 2021-02-26
- Last updated
- 2024-10-04
- Results first posted
- 2024-10-04
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Achievement of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Success at Week 4 | 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. |
| Secondary | Achievement of vIGA-AD Success at Week 4 in Participants With "Moderate" Baseline Scores | Week 4 | 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. |
| Secondary | vIGA-AD Success at Week 2 | Week 2 | 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. |
| Secondary | vIGA-AD Success at Week 1 | Week 1 | 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. |
| Secondary | Achievement of a 4-point Reduction at Week 4 in the Average, Weekly Worst Itch Numeric Rating Scale (WI-NRS) in Participants With Baseline WI-NRS Score ≥4 | Week 4 | The percentage of participants with a baseline WI-NRS ≥ 4 achieving WI-NRS success 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). |
| Secondary | Achievement of a 4-point Reduction at Week 2 in the WI-NRS in Participants With Baseline WI-NRS Score ≥4 | Week 2 | The percentage of participants with a baseline WI-NRS ≥ 4 achieving WI-NRS success 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). |
| Secondary | Achievement of a 4-point Reduction at Week 1 in the WI-NRS in Participants With Baseline WI-NRS Score ≥4 | Week 1 | The percentage of participants with a baseline WI-NRS ≥ 4 achieving WI-NRS success 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). |
| Secondary | Achievement of ≥75% Decrease From Baseline at Week 4 in the Eczema Area and Severity Index (EASI-75) | 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. |
| Secondary | Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 4 | Week 4 | The percentage of participants scoring 'clear' or 'almost clear' on viGA-AD 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. |
| Secondary | Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 2 | Week 2 | The percentage of participants scoring 'clear' or 'almost clear' on viGA-AD 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Achievement of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Success at Week 4 | Week 4 | All randomized participants are included. | percentage of participants | NUMBER |
| SECONDARY | Achievement of vIGA-AD Success at Week 4 in Participants With Moderate Baseline Scores | Week 4 | All randomized participants who were included in the moderate baseline vIGA-AD group during randomization are included. | percentage of participants | NUMBER |
| SECONDARY | vIGA-AD Success at Week 2 | Week 2 | All randomized participants are included. | percentage of participants | NUMBER |
| SECONDARY | vIGA-AD Success at Week 1 | Week 1 | All randomized participants are included. | percentage of participants | NUMBER |
| SECONDARY | Achievement of a 4-point Reduction at Week 4 in the Average, Weekly Worst Itch Numeric Rating Scale (WI-NRS) in Participants With Baseline WI-NRS Score ≥4 | Week 4 | All randomized participants who were ≥12 years of age, had an average weekly WI-NRS pruritus score ≥4 at baseline, and completed at least 4 of 7 evaluable daily WI-NRS questionnaires during the last 7 days of the Screening period are included. Multiple imputation was used to handle missing cases. | percentage of participants | NUMBER |
| SECONDARY | Achievement of a 4-point Reduction at Week 2 in the WI-NRS in Participants With Baseline WI-NRS Score ≥4 | Week 2 | All randomized participants who were ≥12 years of age, had an average weekly WI-NRS pruritus score ≥4 at baseline, and completed at least 4 of 7 evaluable daily WI-NRS questionnaires during the last 7 days of the Screening period are included. Multiple imputation was used to handle missing cases. | percentage of participants | NUMBER |
| SECONDARY | Achievement of a 4-point Reduction at Week 1 in the WI-NRS in Participants With Baseline WI-NRS Score ≥4 | Week 1 | All randomized participants who were ≥12 years of age, had an average weekly WI-NRS pruritus score ≥4 at baseline, and completed at least 4 of 7 evaluable daily WI-NRS questionnaires during the last 7 days of the Screening period are included. Multiple imputation was used to handle missing cases. | percentage of participants | NUMBER |
| SECONDARY | Achievement of ≥75% Decrease From Baseline at Week 4 in the Eczema Area and Severity Index (EASI-75) | Week 4 | All randomized participants are included. | percentage of participants | NUMBER |
| SECONDARY | Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 4 | Week 4 | All randomized participants are included. | percentage of participants | NUMBER |
| SECONDARY | Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 2 | Week 2 | All randomized participants are included. | percentage of participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Achievement of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Success at Week 4 | Roflumilast Cream 0.15% | 28.9 | percentage of participants | ||
| Achievement of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Success at Week 4 | Vehicle Cream | 12.0 | percentage of participants | ||
| Achievement of vIGA-AD Success at Week 4 in Participants With Moderate Baseline Scores | Roflumilast Cream 0.15% | 32.9 | percentage of participants | ||
| Achievement of vIGA-AD Success at Week 4 in Participants With Moderate Baseline Scores | Vehicle Cream | 13.1 | percentage of participants | ||
| vIGA-AD Success at Week 2 | Roflumilast Cream 0.15% | 17.7 | percentage of participants | ||
| vIGA-AD Success at Week 2 | Vehicle Cream | 5.3 | percentage of participants | ||
| vIGA-AD Success at Week 1 | Roflumilast Cream 0.15% | 5.9 | percentage of participants | ||
| vIGA-AD Success at Week 1 | Vehicle Cream | 3.1 | percentage of participants | ||
| Achievement of a 4-point Reduction at Week 4 in the Average, Weekly Worst Itch Numeric Rating Scale (WI-NRS) in Participants With Baseline WI-NRS Score ≥4 | Roflumilast Cream 0.15% | 30.2 | 95% Confidence Interval 24.77 to 36.31 | percentage of participants | |
| Achievement of a 4-point Reduction at Week 4 in the Average, Weekly Worst Itch Numeric Rating Scale (WI-NRS) in Participants With Baseline WI-NRS Score ≥4 | Vehicle Cream | 12.4 | 95% Confidence Interval 7.77 to 19.26 | percentage of participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Roflumilast Cream 0.15% | 451 | |
| Overall Study | STARTED | Vehicle Cream | 232 | |
| Overall Study | COMPLETED | Roflumilast Cream 0.15% | 410 | |
| Overall Study | COMPLETED | Vehicle Cream | 211 | |
| Overall Study | NOT COMPLETED | Roflumilast Cream 0.15% | 41 | |
| Overall Study | NOT COMPLETED | Vehicle Cream | 21 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Nerve compression | Injury, poisoning and procedural complications | Roflumilast Cream 0.15% | 1 | 452 | |
| serious | Nerve compression | Injury, poisoning and procedural complications | Vehicle Cream | 0 | 232 | |
| serious | Staphylococcal scalded skin syndrome | Infections and infestations | Roflumilast Cream 0.15% | 1 | 452 | |
| serious | Staphylococcal scalded skin syndrome | Infections and infestations | Vehicle Cream | 0 | 232 | |
| serious | General physical health deterioration | General disorders | Roflumilast Cream 0.15% | 1 | 452 | |
| serious | General physical health deterioration | General disorders | Vehicle Cream | 0 | 232 | |
| serious | Dermatitis atopic | Skin and subcutaneous tissue disorders | Roflumilast Cream 0.15% | 1 | 452 | |
| serious | Dermatitis atopic | Skin and subcutaneous tissue disorders | Vehicle Cream | 0 | 232 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Roflumilast Cream 0.15% | 0 | 452 |
| Total, all-cause mortality | Vehicle Cream | 0 | 232 |
| Total, other adverse events | Roflumilast Cream 0.15% | 0 | 452 |
| Total, other adverse events | Vehicle Cream | 0 | 232 |
| Total, serious adverse events | Roflumilast Cream 0.15% | 4 | 452 |
| Total, serious adverse events | Vehicle Cream | 0 | 232 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39292443 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Roflumilast Cream 0.15% vs Vehicle Cream: deaths from any cause | Trial comparisons |
| Roflumilast Cream 0.15% vs Vehicle Cream: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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