ArticleThe Journal of dermatology2019
Efficacy and safety of topical OPA-15406, a new phosphodiesterase 4 inhibitor, in Japanese patients with atopic dermatitis for 8 weeks: A phase 2, randomized, double-blind, placebo-controlled study.
Article in The Journal of dermatology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 26 citations in OpenAlex.
- 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
- 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.The Journal of dermatology · 2020Trial
- 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
- Systematic Literature Review and Network Meta-Analysis of Clinical Efficacy and Safety of Topical Treatments for Patients with Atopic Dermatitis.Dermatology and therapy · 2025Review
- Cost-Effectiveness Study of Difamilast 1% for the Treatment of Atopic Dermatitis in Adult Japanese Patients.Dermatology and therapy · 2024Article
- Matching-Adjusted Indirect Comparison of the Efficacy and Safety of Difamilast 1% and Delgocitinib 0.5% in Patients with Moderate-to-Severe Atopic Dermatitis.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
- Difamilast for the treatment of atopic dermatitis.The Journal of international medical research · 2023Review
- Treatment Options for Troublesome Itch.Pharmaceuticals (Basel, Switzerland) · 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
Corrections and comments
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Authors and funding
5 authors at 3 institutions in 1 country.
Funding
Abstract
The efficacy and safety of topical OPA-15406, a new phosphodiesterase 4 inhibitor, were examined in Japanese patients aged 15-70 years with atopic dermatitis in a phase 2, randomized, double-blind, vehicle-controlled study. Two hundred patients were randomized to three treatment groups at a 1:1:1 ratio to receive OPA-15406 0.3%, OPA-15406 1% or vehicle ointment twice daily for 8 weeks. The OPA-15406 1% group was superior to the vehicle group in terms of the incidence of success based on the Investigator Global Assessment score at week 4 (P = 0.0328), which was the primary end-point, while the OPA-15406 0.3% group showed a trend toward improvement in the primary end-point. The mean Eczema Area and Severity Index total score and subscale (erythema, induration/papulation, excoriation and lichenification) scores, the Visual Analog Scale pruritus score and the Patient-Oriented Eczema Measure score were significantly improved and the percentage of affected body surface area was significantly decreased in both OPA-15406 groups relative to the vehicle group as early as week 1, and the improved scores and decreased percentages were generally maintained until week 8. No deaths or serious treatment-emergent adverse events occurred in the OPA-15406 treatment groups. Treatment-emergent adverse events frequently observed across treatment groups were worsening of atopic dermatitis, viral upper respiratory tract infection and pruritus, all of which were mild or moderate in severity in the OPA-15406 groups. OPA-15406 1% ointment showed favorable efficacy and safety profiles, indicating a promising treatment option for patients with atopic dermatitis.
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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.