Trial reportPharmaceutical research2013
Development and clinical study of a self-dissolving microneedle patch for transcutaneous immunization device.
Trial report in Pharmaceutical research, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 1 of them a synthesis 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
34 citing papers in PubMed, 1 synthesis or guideline pooled it, 104 citations in OpenAlex.
- Immunogenicity, safety, usability and acceptability of microarray patches for vaccination: a systematic review and meta-analysis.BMJ global health · 2023Pooled it
- The safety, immunogenicity, and acceptability of inactivated influenza vaccine delivered by microneedle patch (TIV-MNP 2015): a randomised, partly blinded, placebo-controlled, phase 1 trial.Lancet (London, England) · 2017Trial
- Development and in vitro tuning of empagliflozin-containing dissolvable microneedle patch for enhanced transdermal delivery.Naunyn-Schmiedeberg's archives of pharmacology · 2025Article
- Fabrication and Evaluation of Dissolving Hyaluronic Acid Microneedle Patches for Minimally Invasive Transdermal Drug Delivery by Nanoimprinting.Gels (Basel, Switzerland) · 2025Article
- Sustained release microneedle patch for pronounced systemic delivery of doxazosin mesylate.BioImpacts : BI · 2025Article
- Advances in microneedles for transdermal diagnostics and sensing applications.Mikrochimica acta · 2024Review
- Fourth dose of microneedle array patch of SARS-CoV-2 S1 protein subunit vaccine elicits robust long-lasting humoral responses in mice.International immunopharmacology · 2024Article
- Mechanical Characterization of Dissolving Microneedles: Factors Affecting Physical Strength of Needles.Pharmaceutics · 2024Article
- Fabrication and Characterization of Dissolving Microneedles for Transdermal Drug Delivery of Apomorphine Hydrochloride in Parkinson's Disease.Pharmaceutical research · 2024Article
- Fabrication and evaluation of nanoemulsion based insulin loaded microneedles for transdermal drug delivery.Therapeutic delivery · 2024Article
- Formulation and characterization of thiolated chitosan/polyvinyl acetate based microneedle patch for transdermal delivery of dydrogesterone.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2023Article
- Review
- Experimental Validation of Diffraction Lithography for Fabrication of Solid Microneedles.Materials (Basel, Switzerland) · 2022Article
- Simvastatin Loaded Dissolvable Microneedle Patches with Improved Pharmacokinetic Performance.Micromachines · 2022Article
- Potential of Microneedle Systems for COVID-19 Vaccination: Current Trends and Challenges.Pharmaceutics · 2022Review
- Microneedle-Based Vaccine Delivery: Review of an Emerging Technology.AAPS PharmSciTech · 2022Review
- Transcutaneous Administration of Imiquimod Promotes T and B Cell Differentiation into Effector Cells or Plasma Cells.Pharmaceutics · 2022Article
- Article
- Evolving pharmacovigilance requirements with novel vaccines and vaccine components.BMJ global health · 2021Review
- Dissolvable Microneedle Patches to Enable Increased Access to Vaccines against SARS-CoV-2 and Future Pandemic Outbreaks.Vaccines · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeWe previously reported the safety and efficacy in animal experiments of transcutaneous immunization (TCI) using a self-dissolving microneedle patch (MicroHyala; MH) made of hyaluronic acid and collagen. However, this MH was an unsuitable TCI device for the human skin, as collagen is suspected to induce inflammation. In this study, we developed an improved collagen-free MH (new-MH) and conducted clinical study to evaluate the fundamental properties and safety in human.
methodsMicroneedle dissolution, skin irritation, and antigen-specific antibody production about new-MH were measured in mice and/or rats. On the basis of the results, the clinical study was conducted in healthy volunteers to evaluate local and systemic adverse events caused by new-MH application.
resultsWe confirmed that the microneedles of new-MH, as well as those on our old-MH that contained collagen, could easily pierce stratum corneum without severe skin irritation, and that TCI using new-MH efficiently increased antibody titer with comparable to TCI using old-MH. Application of new-MH caused no severe adverse reactions in 20 healthy volunteers enrolled in a clinical study.
conclusionsThese results verified that new-MH is a safe TCI device in human, and greatly encouraged us to advance PI/PII clinical studies of antigen-loaded new-MH.
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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.