Trial reportAmerican journal of clinical dermatology2023
Pharmacokinetics of Roflumilast Cream in Chronic Plaque Psoriasis: Data from Phase I to Phase III Studies.
Trial report in American journal of clinical dermatology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 17 papers, 2 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.
A Phase 1/2a Single Dose and 28-day Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety, Pharmacokinetics and Efficacy of ARQ-151 Cream 0.5% and 0.15% in Adults With Mild to Moderate Chronic Plaque Psoriasis
A Phase 3, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.3% Administered QD in Subjects With Chronic Plaque Psoriasis
A Phase 3, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.3% Administered QD in Subjects With Chronic Plaque Psoriasis
An Open Label, Phase 1, Maximal Usage Pharmacokinetics and Safety Study of ARQ-151 Cream 0.3% Administered QD in Adolescent and Adult Subjects With Chronic Plaque Psoriasis
Who cites it
17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 31 citations in OpenAlex.
- 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
- Considerations for Genital Psoriasis Care Across Age Groups: A Modified Delphi Consensus Initiative from the Genital Psoriasis Wellness Consortium.American journal of clinical dermatology · 2026Pooled it
- Early Evidence of Safety, Clinical Benefit, and Pharmacokinetics of Roflumilast Cream 0.3% Once Daily for Treatment of Mild or Moderate Plaque Psoriasis in Children Aged 2-11 Years.Pediatric dermatology · 2025Trial
- Skin Barrier-Informed Topical and Transdermal Drug Delivery: Excipient-Driven Strategies, Vehicle Transformation, and Translational Challenges.Pharmaceutics · 2026Review
- A review of current therapeutics for psoriasis: Systemic and topical use of non-biological drugs.European journal of clinical pharmacology · 2026Review
- Practical considerations for managing patients being treated with topical roflumilast.Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques · 2026Review
- Targeting Intracellular Pathways in Atopic Dermatitis with Small Molecule Therapeutics.Current issues in molecular biology · 2025Review
- Patient Satisfaction with Calcipotriol/Betamethasone Dipropionate Cream in Psoriatic Patients Previously Treated With Foam Vehicle.Dermatology practical & conceptual · 2025Article
- Structural Insights: What Makes Some PDE4 Inhibitors More Effective in Inflammatory Dermatoses.The Journal of clinical and aesthetic dermatology · 2025Review
- PDE4 inhibitors in psoriasis therapy: current insights and future directions.Inflammopharmacology · 2025Review
- [Modern topical drugs-new developments in galenics and pharmacology].Dermatologie (Heidelberg, Germany) · 2024Review
- Skin Penetration and Permeation Properties of TranscutolAAPS PharmSciTech · 2024Review
- Insights into Inhalation Drug Disposition: The Roles of Pulmonary Drug-Metabolizing Enzymes and Transporters.International journal of molecular sciences · 2024Review
- Successful treatment of nail psoriasis with topical roflumilast: A case report.SAGE open medical case reports · 2024Article
- Topical Management of Pediatric Psoriasis: A Review of New Developments and Existing Therapies.Paediatric drugs · 2024Review
- Novel Therapeutic Targets for the Treatment of Atopic Dermatitis.Biomedicines · 2023Review
- Roflumilast in Dermatology: A Newer Phosphodiesterase-4 Inhibitor.Indian journal of dermatologyArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundMost patients with chronic plaque psoriasis receive topical treatment; however, available options lack a balance of efficacy with long-term safety and tolerability. Roflumilast cream 0.3% is a highly potent phosphodiesterase 4 (PDE4) inhibitor approved by the US FDA for treatment of psoriasis.
objectiveThe aim of this study was to define the pharmacokinetic (PK) profile of roflumilast delivered topically from a phase I maximal usage study and data from phase II and phase III studies.
methodsPK data for roflumilast and the active metabolite, roflumilast N-oxide, were determined from a phase I PK and safety maximal usage study of roflumilast cream 0.3% applied once daily for 14 days in patients with plaque psoriasis affecting body surface area (BSA) ≥20% (N = 26). Serial plasma samples were obtained on Days 1 and 15 to determine maximum plasma concentration (C
resultsBioavailability of roflumilast cream 0.3% after topical administration was 1.5%. Unlike after oral dosing, the plasma concentration-time curve was flat, with a peak-to-trough ratio of 1.2. Roflumilast N-oxide concentrations were eightfold higher than roflumilast concentrations. The t
conclusionTopical administration of roflumilast cream 0.3% results in concentrations in skin 126- and 61.8-fold higher relative to plasma, which are much higher than expected to be achievable with oral dosing. PDE4 inhibition in the skin is likely due to roflumilast as compared with its active metabolite, as there is no significant conversion to roflumilast N-oxide in the skin. Consistent with reservoir formation and retention of drug in the stratum corneum, roflumilast is slowly released from the skin (t CLINICALTRIALS: GOV IDENTIFIERS: NCT04279119, NCT03392168, NCT04211363, NCT04211389.
Indexed as
Identifiers
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.