Trial · NCT04845620
Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED)
NCT04845620, Phase 3, Completed, Arcutis Biotherapeutics, Inc.; results first posted 2025-12-23
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-PED). Trials, record NCT04845620. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04845620
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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-PED)
- NCT number
- NCT04845620
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 652 participants, actual
- Lead sponsor
- Arcutis Biotherapeutics, Inc.
- Conditions
- Atopic Dermatitis Eczema
- Interventions
- Roflumilast Cream 0.05%, Vehicle Cream
- First posted
- 2021-04-15
- Last updated
- 2025-12-23
- Results first posted
- 2025-12-23
Source ClinicalTrials.gov
Registered outcomes8
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 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. |
| Secondary | Achievement of vIGA-AD Success at Week 4 in Participants With 'Moderate' Baseline vIGA-AD | 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. |
| Secondary | Achievement of 75% Reduction in the Eczema Area and Severity Index (EASI-75) at Week 4 In Participants With 'Moderate' Baseline vIGA | 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. |
| Secondary | Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' | 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. |
| Secondary | Achievement of vIGA-AD Success at Week 2 | 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. |
| Secondary | Achievement of vIGA-AD Success at Week 1 | 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. |
| Secondary | Achievement of vIGA-AD of 'Clear' or 'Almost Clear' at Week 2 | 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. |
| Secondary | Achievement of vIGA-AD of 'Clear' or 'Almost Clear' at Week 1 | 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. |
Source ClinicalTrials.gov
Outcomes8
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, 1 participant in the Roflumilast Cream 0.05% arm was inadvertently treated prior to randomization and thus excluded from analysis. | percentage of participants | NUMBER |
| SECONDARY | Achievement of vIGA-AD Success at Week 4 in Participants With 'Moderate' Baseline vIGA-AD | Week 4 | All randomized participants with a baseline vIGA score of 'moderate' are included. | percentage of participants | NUMBER |
| SECONDARY | Achievement of 75% Reduction in the Eczema Area and Severity Index (EASI-75) at Week 4 In Participants With 'Moderate' Baseline vIGA | Week 4 | All randomized participants are included, with the exception of 1 participant in the Roflumilast Cream 0.05% arm who was inadvertently treated prior to randomization and thus excluded from analysis. | percentage of participants | NUMBER |
| SECONDARY | Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' | Week 4 | All randomized participants are included, 1 participant in the Roflumilast Cream 0.05% arm was inadvertently treated prior to randomization and thus excluded from analysis. | percentage of participants | NUMBER |
| SECONDARY | Achievement of vIGA-AD Success at Week 2 | Week 2 | All randomized participants are included, 1 participant in the Roflumilast Cream 0.05% arm was inadvertently treated prior to randomization and thus excluded from analysis. | percentage of participants | NUMBER |
| SECONDARY | Achievement of vIGA-AD Success at Week 1 | Week 1 | All randomized participants are included, 1 participant in the Roflumilast Cream 0.05% arm was inadvertently treated prior to randomization and thus excluded from analysis. | percentage of participants | NUMBER |
| SECONDARY | Achievement of vIGA-AD of 'Clear' or 'Almost Clear' at Week 2 | Week 2 | All randomized participants are included, 1 participant in the Roflumilast Cream 0.05% arm was inadvertently treated prior to randomization and thus excluded from analysis. | percentage of participants | NUMBER |
| SECONDARY | Achievement of vIGA-AD of 'Clear' or 'Almost Clear' at Week 1 | Week 1 | All randomized participants are included, 1 participant in the Roflumilast Cream 0.05% arm was inadvertently treated prior to randomization and thus excluded from analysis. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group16
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 0.05% | 25.4 | 97.5% Confidence Interval 20.95 to 30.34 | percentage of participants | |
| Achievement of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Success at Week 4 | Vehicle Cream | 10.7 | 97.5% Confidence Interval 6.77 to 16.45 | percentage of participants | |
| Achievement of vIGA-AD Success at Week 4 in Participants With 'Moderate' Baseline vIGA-AD | Roflumilast Cream 0.05% | 27.7 | 97.5% Confidence Interval 22.55 to 33.62 | percentage of participants | |
| Achievement of vIGA-AD Success at Week 4 in Participants With 'Moderate' Baseline vIGA-AD | Vehicle Cream | 11.0 | 97.5% Confidence Interval 6.67 to 17.73 | percentage of participants | |
| Achievement of 75% Reduction in the Eczema Area and Severity Index (EASI-75) at Week 4 In Participants With 'Moderate' Baseline vIGA | Roflumilast Cream 0.05% | 39.4 | 97.5% Confidence Interval 34.21 to 44.81 | percentage of participants | |
| Achievement of 75% Reduction in the Eczema Area and Severity Index (EASI-75) at Week 4 In Participants With 'Moderate' Baseline vIGA | Vehicle Cream | 20.6 | 97.5% Confidence Interval 15.06 to 27.55 | percentage of participants | |
| Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' | Roflumilast Cream 0.05% | 35.4 | 97.5% Confidence Interval 30.39 to 40.66 | percentage of participants | |
| Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' | Vehicle Cream | 14.6 | 97.5% Confidence Interval 9.94 to 20.86 | percentage of participants | |
| Achievement of vIGA-AD Success at Week 2 | Roflumilast Cream 0.05% | 21.2 | 97.5% Confidence Interval 17.13 to 25.98 | percentage of participants | |
| Achievement of vIGA-AD Success at Week 2 | Vehicle Cream | 6.8 | 97.5% Confidence Interval 3.85 to 11.88 | percentage of participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 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 0.05% | 437 | |
| Overall Study | STARTED | Vehicle Cream | 215 | |
| Overall Study | COMPLETED | Roflumilast Cream 0.05% | 410 | |
| Overall Study | COMPLETED | Vehicle Cream | 192 | |
| Overall Study | NOT COMPLETED | Roflumilast Cream 0.05% | 27 | |
| Overall Study | NOT COMPLETED | Vehicle Cream | 23 |
Source ClinicalTrials.gov
Adverse events2
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 | Cellulitis | Skin and subcutaneous tissue disorders | Roflumilast Cream 0.05% | 1 | 437 | |
| serious | Cellulitis | Skin and subcutaneous tissue disorders | Vehicle Cream | 0 | 215 |
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 0.05% | 0 | 437 |
| Total, all-cause mortality | Vehicle Cream | 0 | 215 |
| Total, other adverse events | Roflumilast Cream 0.05% | 0 | 437 |
| Total, other adverse events | Vehicle Cream | 0 | 215 |
| Total, serious adverse events | Roflumilast Cream 0.05% | 1 | 437 |
| Total, serious adverse events | Vehicle Cream | 0 | 215 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 0.05% vs Vehicle Cream: deaths from any cause | Trial comparisons |
| Roflumilast Cream 0.05% 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.
The record and each of its lists are JSON, twenty rows a page. No key.
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