Trial reportPediatric dermatology
Efficacy and Safety of Once-Daily Roflumilast Cream 0.05% in Pediatric Patients Aged 2-5 Years With Mild-to-Moderate Atopic Dermatitis (INTEGUMENT-PED): A Phase 3 Randomized Controlled Trial.
Trial report in Pediatric dermatology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04845620 (A Phase 3, 4-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.05% Administered QD in Subjects With Atopic Dermatitis), which is not on this map. Cited by 12 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3, 4-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.05% Administered QD in Subjects With Atopic Dermatitis
Who cites it
12 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Assessing the Adverse Events of Roflumilast and Tapinarof Use in Pediatric and Young Adult Patients with Atopic Dermatitis: A Systematic Review.Clinical drug investigation · 2026Pooled it
- Novel nonsteroidal topical therapies for pediatric atopic dermatitis: a systematic review and network meta-analysis of randomized controlled trials.Frontiers in immunology · 2026Pooled it
- Trial
- PDE4 Inhibition in Dermatologic Disease: Impacts Beyond Inflammation.International journal of dermatology · 2026Review
- Pushing the Boundaries of Topical Therapy in Patients with Atopic Dermatitis: A Review of Baseline Disease Severity and Burden in Clinical Trials.Dermatology and therapy · 2026Review
- Emerging topical nonsteroidal therapies in pediatric dermatology: atopic dermatitis, psoriasis, alopecia areata, vitiligo, and seborrheic dermatitis.Current opinion in pediatrics · 2026Review
- Understanding Infantile Atopic Dermatitis: A Review of Environmental, Familial, Genetic and Microbial Influences.Current allergy and asthma reports · 2026Review
- Epithelial Barrier Dysfunction in Atopic Dermatitis, Allergic Contact Dermatitis, and Chronic Spontaneous Urticaria and its Therapeutic Implications.Current allergy and asthma reports · 2026Review
- Expanding the Topical Therapeutic Landscape for Atopic Dermatitis: A Systematic Review.The Journal of clinical and aesthetic dermatology · 2026Review
- Efficacy and safety of PDE4 inhibitor monotherapy in adult patients with atopic dermatitis: a systematic review and meta-analysis.Postepy dermatologii i alergologii · 2026Review
- PDE4 Inhibitor-Responsive Dermatoses: An Emerging Concept in Dermatology.The Journal of clinical and aesthetic dermatology · 2025Review
- Targeting Intracellular Pathways in Atopic Dermatitis with Small Molecule Therapeutics.Current issues in molecular biology · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors.
Funding
Abstract
BACKGROUND/
objectivesEfficacy and safety of roflumilast cream 0.15% were demonstrated in patients aged ≥ 6 years with atopic dermatitis (AD) in two Phase 3 trials. This Phase 3 parallel-group, double-blind trial (INTEGUMENT-PED; NCT04845620) compared the efficacy and safety of roflumilast cream 0.05% and a vehicle in patients aged 2-5 years with AD.
methodsPatients aged 2-5 years with mild-to-moderate AD were treated with once-daily roflumilast cream 0.05% or vehicle for 4 weeks. The primary efficacy endpoint was Validated Investigator Global Assessment for AD (vIGA-AD) Success (0 [Clear] or 1 [Almost Clear] plus ≥ 2-grade improvement from baseline) at Week 4. Other endpoints included ≥ 75% improvement in Eczema Area and Severity Index (EASI-75) and Worst Itch-Numeric Rating Score (WI-NRS) Success (≥ 4-point improvement in patients with baseline ≥ 4). Safety and tolerability were also assessed.
resultsAmong 437 and 215 patients treated with roflumilast and vehicle, respectively, significantly greater proportions of the roflumilast group achieved Week-4 vIGA-AD Success (25.4% vs. 10.7%; p < 0.0001), EASI-75 (39.4% vs. 20.6%; p < 0.0001), and WI-NRS Success (35.3% vs. 18.0%; nominal p = 0.0002). Improvement in pruritus was observed within 24 h after the first application (nominal p = 0.0014). Treatment-emergent adverse event (TEAE) rates were low in both groups, and 98.9% were mild or moderate. At all timepoints, stinging/burning that caused definite discomfort was reported by ≤ 0.7% of caregivers of patients in the roflumilast group.
conclusionsIn this Phase 3 trial, once-daily roflumilast cream 0.05% improved AD signs/symptoms in patients aged 2-5 years, with early pruritus improvement, low AE rates, and local tolerability comparable with vehicle.
trial registrationClinicalTrials.gov: NCT04845620.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.