Phase 3
N=652
Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED)
Atopic Dermatitis Eczema
Bottom Line
View on ClinicalTrials.gov: NCT04845620 ↗Enrolled (actual)
652
Serious AEs
0.2%
Results posted
Dec 2025
Primary outcome: Primary: Achievement of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Success at Week 4 — 25.4; 10.7 percentage of participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Roflumilast Cream 0.05% (Drug); Vehicle Cream (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Arcutis Biotherapeutics, Inc.
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Achievement of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Success at Week 4 |
25.4; 10.7 | <0.0001 sig |
| SECONDARY Achievement of vIGA-AD Success at Week 4 in Participants With 'Moderate' Baseline vIGA-AD |
27.7; 11.0 | <0.0001 sig |
| SECONDARY Achievement of 75% Reduction in the Eczema Area and Severity Index (EASI-75) at Week 4 In Participants With 'Moderate' Baseline vIGA |
39.4; 20.6 | <0.0001 sig |
| SECONDARY Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' |
35.4; 14.6 | <0.0001 sig |
| SECONDARY Achievement of vIGA-AD Success at Week 2 |
21.2; 6.8 | <0.0001 sig |
| SECONDARY Achievement of vIGA-AD Success at Week 1 |
9.4; 0.9 | <0.0001 sig |
| SECONDARY Achievement of vIGA-AD of 'Clear' or 'Almost Clear' at Week 2 |
30.4; 10.6 | <0.0001 sig |
| SECONDARY Achievement of vIGA-AD of 'Clear' or 'Almost Clear' at Week 1 |
17.00; 3.7 | <0.0001 sig |
Summary
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).
Eligibility Criteria
Inclusion Criteria
- Informed consent by parent(s) or legal guardian as required by local laws.
- Males and females, ages 2 to 5 years old at time of signing Informed Consent (Screening) and at Baseline (Day 1).
- 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.
- In good health as judged by the Investigator.
- Subjects considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.
Exclusion Criteria
- 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
- Has unstable AD or any consistent requirement for high potency topical steroids.
- Subjects who are unwilling to refrain from prolonged sun exposure for 4 weeks prior to Baseline/Day 1 and during the study.
- Previous treatment with ARQ-151.
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT04845620). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.