Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
NCT07916480, Phase 3, Recruiting, Arcutis Biotherapeutics, Inc.
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis | ClinicalTrials.gov |
| NCT number | NCT07916480 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Phase 3 | ClinicalTrials.gov |
| Enrollment | 415 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Arcutis Biotherapeutics, Inc. | ClinicalTrials.gov |
| Conditions | Atopic Dermatitis, Atopic Dermatitis (AD), Atopic Dermatitis (Eczema) | ClinicalTrials.gov |
| Interventions | Roflumilast Cream 0.3%, Vehicle Cream | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Achievement of vIGA-AD Success at Week 4 | Week 4 | vIGA-AD Success is defined as achieving a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of Clear (0) or Almost Clear (1) with at least a 2-grade improvement from Baseline. | ClinicalTrials.gov |
| Secondary | Achievement of at least a 75% reduction in the Eczema Area and Severity Index (EASI-75) | Week 4 | EASI-75 is defined as achieving at least a 75% reduction from Baseline in Eczema Area and Severity Index (EASI) score. | ClinicalTrials.gov |
| Secondary | In participants ≥12 years old with Baseline Itch-NRS ≥ 4, achievement of at least a 4-point reduction on the Itch-NRS | Week 4 | In participants aged ≥12 years and older with a Baseline Itch Numeric Rating Scale (Itch-NRS) score of 4 or greater who achieve at least a 4-point reduction from Baseline in the Itch-NRS score at Week 4. The Itch-NRS is an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), with higher scores indicating greater itch severity. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
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 | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)