Trial reportPediatric dermatology
Long-Term Safety and Efficacy of Once-Daily and Proactive Twice-Weekly Roflumilast Cream 0.05% for Mild-to-Moderate Atopic Dermatitis in Children Aged 2-5 Years From a 52-Week, Phase 3 Trial (INTEGUMENT-OLE).
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 2 registered trials, which are not on this map. Not yet cited in PubMed.
What it found
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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, Multicenter, Open-Label Extension Study of the Long-Term Safety of ARQ-151 Cream 0.15% and ARQ-151 Cream 0.05% in Subjects With Atopic Dermatitis
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
0 citing papers in PubMed.
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Corrections and comments
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Authors and funding
15 authors.
Funding
Abstract
backgroundINTEGUMENT-PED/NCT04845620, a 4-week, phase 3 trial, demonstrated efficacy and safety of roflumilast cream 0.05% in children aged 2-5 years with mild-to-moderate atopic dermatitis (AD). A phase 3 open-label extension trial (INTEGUMENT-OLE [NCT04804605]) investigated long-term outcomes continuing roflumilast cream for ≤ 56 weeks.
methodsCaregivers of eligible patients from INTEGUMENT-PED applied roflumilast cream 0.05% once-daily in INTEGUMENT-OLE. Patients achieving Validated Investigator Global Assessment for AD (vIGA-AD) clear (0) at/after week 4 of INTEGUMENT-OLE switched to twice-weekly (BIW) application. Evaluation of safety (adverse events [AEs] and application-site tolerability) was the primary objective. Efficacy endpoints assessed from INTEGUMENT-PED baseline included vIGA-AD success (clear/almost clear [0/1] plus ≥ 2-point improvement), vIGA-AD 0/1, ≥ 75% improvement in Eczema Area and Severity Index, and Worst Itch-Numeric Rating Scale success (≥ 4-point improvement in patients with baseline score ≥ 4). Duration of vIGA-AD 0/1 and sign/symptom control ("disease control") with BIW application was determined.
resultsAmong 562 patients, 14 (2.5%) had treatment-related AEs reported. Roflumilast was well tolerated; application-site pain AEs were reported for four (0.7%) patients. At treatment-week 56, AD signs/symptoms continued to improve (63.1% of patients achieved vIGA-AD 0/1). Of 170 (30.2%) patients who switched to BIW application, the median Kaplan-Meier duration of "disease control" was 238 days.
conclusionsRoflumilast cream 0.05% demonstrated a favorable long-term safety profile and durable efficacy for up to 56 weeks of treatment in children aged 2-5 years with AD, and "disease control" was maintained with BIW application. These results are consistent with previous studies, including patients aged ≥ 6 years from INTEGUMENT-OLE.
trial registrationClinicaltrials.gov identifier: NCT04845620.
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