Trial reportThe British journal of dermatology2022
Difamilast, a selective phosphodiesterase 4 inhibitor, ointment in paediatric patients with atopic dermatitis: a phase III randomized double-blind, vehicle-controlled trial.
Trial report in The British journal of dermatology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 4 of them syntheses that pooled it.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
25 citing papers in PubMed, 4 syntheses or guidelines pooled it, 63 citations in OpenAlex.
- Efficacy and safety of treatments for atopic dermatitis: a model based meta-analysis of randomized controlled trials.European journal of clinical pharmacology · 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
- Effectiveness and safety of topical phosphodiesterase 4 inhibitors in children with mild-to-moderate atopic dermatitis: A systematic review and meta-analysis.The Journal of international medical research · 2025Pooled it
- Topical anti-inflammatory treatments for eczema: network meta-analysis.The Cochrane database of systematic reviews · 2024Pooled it
- 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
- From Barrier Disruption and Immune Dysregulation to Targeted Therapies in Atopic Dermatitis.Clinical reviews in allergy & immunology · 2026Review
- Phosphodiesterase 4B (PDE4B) inhibitors and their applications in recent years (2014 to early 2025).Molecular diversity · 2026Review
- A Phase 3, Long-Term, Open-Label Study of Difamilast Ointment to Evaluate Efficacy and Safety in Japanese Infants with Atopic Dermatitis.Dermatology and therapy · 2026Article
- Efficacy and safety of PDE4 inhibitor monotherapy in adult patients with atopic dermatitis: a systematic review and meta-analysis.Postepy dermatologii i alergologii · 2026Review
- Defining "Flares" in Atopic Dermatitis: A Narrative Review.American journal of clinical dermatology · 2025Review
- DIFENSE Study Protocol: Early Intervention With Difamilast Ointment in Infantile Early-Onset Atopic Dermatitis for Prevention of Transcutaneous Sensitisation.Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology · 2025Article
- Exploring the Therapeutic Landscape: A Narrative Review on Topical and Oral Phosphodiesterase-4 Inhibitors in Dermatology.Pharmaceutics · 2025Review
- Cost-Effectiveness Study of Difamilast 1% for the Treatment of Atopic Dermatitis in Adult Japanese Patients.Dermatology and therapy · 2024Article
- An Interim Report of a Phase 3, Long-Term, Open-Label Study to Evaluate Efficacy and Safety of Difamilast Ointment in Japanese Infants with Atopic Dermatitis.Dermatology and therapy · 2024Article
- Biologic and Small Molecule Therapy in Atopic Dermatitis.Biomedicines · 2024Review
- Topical Treatments in Atopic Dermatitis: An Expansive Review.Journal of clinical medicine · 2024Review
- Novel Topical Treatments for Itch.Dermatology and therapy · 2024Review
- Challenges and Future Trends in Atopic Dermatitis.International journal of molecular sciences · 2023Review
- Difamilast for the treatment of atopic dermatitis.The Journal of international medical research · 2023Review
- The translational revolution in atopic dermatitis: the paradigm shift from pathogenesis to treatment.Cellular & molecular immunology · 2023Review
Corrections and comments
- Commented on byA new topical.2022
Authors and funding
5 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn atopic dermatitis (AD), phosphodiesterase 4 (PDE4) inhibition reduces proinflammatory mediators and cytokines. Difamilast is a new selective PDE4 inhibitor.
objectivesTo demonstrate the superiority of topical difamilast to vehicle in Japanese paediatric patients with AD.
methodsThis was a phase III randomized, double-blind, vehicle-controlled trial. Patients aged 2-14 years with an Investigator Global Assessment (IGA) score of 2 or 3 received difamilast 0·3% (n = 83), difamilast 1% (n = 85) or vehicle (n = 83) ointment twice daily for 4 weeks.
resultsThe primary endpoint was the percentage of patients with an IGA score of 0 or 1 with improvement by at least two grades at week 4. The success rates in IGA score at week 4 were 44·6%, 47·1% and 18·1% in the difamilast 0·3%, difamilast 1% and vehicle groups, respectively. Both difamilast groups demonstrated significantly higher success rates in IGA score compared with vehicle at week 4 [difamilast 0·3% (P < 0·001); difamilast 1% (P < 0·001)]. Regarding secondary endpoints, improvements in Eczema Area and Severity Index (EASI; improvement of ≥ 50%, ≥ 75% and ≥ 90% in overall score) at week 4 were significantly higher in patients in the difamilast 0·3% and 1% groups than those in the vehicle group. EASI score in the difamilast 0·3% and 1% groups was significantly reduced compared with that of patients in the vehicle group at week 1. The significant difference between both the difamilast groups and the vehicle groups was maintained from week 1 through to week 4. Most treatment-emergent adverse events were mild or moderate, and no serious events or deaths were reported.
conclusionsDifamilast 0·3% and 1% ointments are superior to vehicle and well tolerated in Japanese paediatric patients with AD.
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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.