Trial reportThe Journal of dermatology2020
Phase 2, randomized, double-blind, placebo-controlled, 4-week study to evaluate the safety and efficacy of OPA- 15406 (difamilast), a new topical selective phosphodiesterase type-4 inhibitor, in Japanese pediatric patients aged 2-14 years with atopic dermatitis.
Trial report in The Journal of dermatology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 5 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
20 citing papers in PubMed, 5 syntheses or guidelines pooled it, 39 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
- Comparative efficacy of pediatric atopic dermatitis treatments: a network meta-analysis highlighting dupilumab and pimecrolimus for SCORAD and EASI improvement.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
- Difamilast, a selective phosphodiesterase 4 inhibitor, ointment in paediatric patients with atopic dermatitis: a phase III randomized double-blind, vehicle-controlled trial.The British journal of dermatology · 2022Trial
- A phase 3, multicenter, randomized, double-blind, vehicle-controlled, parallel-group study of 5% sofpironium bromide (BBI-4000) gel in Japanese patients with primary axillary hyperhidrosis.The Journal of dermatology · 2021Trial
- 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
- Defining "Flares" in Atopic Dermatitis: A Narrative Review.American journal of clinical dermatology · 2025Review
- Targeting Intracellular Pathways in Atopic Dermatitis with Small Molecule Therapeutics.Current issues in molecular biology · 2025Review
- Molecular and cellular mechanisms of itch sensation and the anti-itch drug targets.Acta pharmacologica Sinica · 2025Review
- 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
- Topical Treatments in Atopic Dermatitis: An Expansive Review.Journal of clinical medicine · 2024Review
- Novel Topical Treatments for Itch.Dermatology and therapy · 2024Review
- Difamilast for the treatment of atopic dermatitis.The Journal of international medical research · 2023Review
- Treatment Options for Troublesome Itch.Pharmaceuticals (Basel, Switzerland) · 2022Review
- Atopic dermatitis: an expanding therapeutic pipeline for a complex disease.Nature reviews. Drug discovery · 2022Review
- Safety Profile and Tolerability of Topical Phosphodiesterase 4 Inhibitors for the Treatment of Atopic Dermatitis: A Systematic Review and Meta-Analysis.Current therapeutic research, clinical and experimental · 2022Article
- Treatments for Childhood Atopic Dermatitis: an Update on Emerging Therapies.Clinical reviews in allergy & immunology · 2021Review
- Anti-inflammatory topical medication - new developments in the treatment of atopic dermatitis.Allergologie select · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 3 institutions in 1 country.
Funding
Abstract
The safety and efficacy of OPA-15406 (international non-proprietary name, difamilast; also referred to as MM36), a new topical, selective phosphodiesterase type-4 inhibitor, in Japanese pediatric patients with atopic dermatitis aged 2-14 years were evaluated in a phase 2, randomized, double-blind, vehicle-controlled, 4-week study. Seventy-three patients were randomized 1:1:1 to receive OPA-15406 0.3%, OPA-15406 1% or vehicle ointment twice daily for 4 weeks. The mean age of patients was similar across treatment groups. No deaths or serious treatment-emergent adverse events were reported; all treatment-emergent adverse events were mild or moderate in severity. The incidence of treatment-emergent adverse events leading to treatment discontinuation was 4.2% (1/24) in the OPA-15406 0.3% group, 4.0% (1/25) in the OPA-15406 1% group and 16.7% (4/24) in the vehicle group, all of which were worsening of atopic dermatitis. Both OPA-15406 groups demonstrated a higher incidence of success in the Investigator Global Assessment score compared with the vehicle group over the 4-week study. The OPA-15406 groups also showed greater improvements from baseline compared with the vehicle group in the Investigator Global Assessment score, Eczema Area and Severity Index overall score and subscale (erythema, induration/papulation, excoriation and lichenification) scores, Visual Analog Scale pruritus score, Patient-Oriented Eczema Measure score, and percentage of affected body surface area over the 4-week study. Topical OPA-15406 twice daily for 4 weeks was considered a safe and effective treatment option in this phase 2 study in pediatric patients with atopic dermatitis, and phase 3 development is currently ongoing.
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What OpenQuestion holds
Registered trials
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.