Trial reportPharmaceutical research2013
Diclofenac enables unprecedented week-long microneedle-enhanced delivery of a skin impermeable medication in humans.
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 18 papers.
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
18 citing papers in PubMed, 46 citations in OpenAlex.
- Micropore visualization and lifetime following microneedle application to skin of differing pigments.Drug delivery and translational research · 2025Trial
- Mathematical modelling of hollow microneedle-mediated transdermal drug delivery.Drug delivery and translational research · 2025Article
- Impact of Formulation and Microneedle Length on Transdermal Metronidazole Permeation through Microneedle-Treated Skin.Pharmaceutical research · 2024Article
- Thermosensitive biomaterial gels with chemical permeation enhancers for enhanced microneedle delivery of naltrexone for managing opioid and alcohol dependency.Biomaterials science · 2023Article
- Microneedle-Mediated Transdermal Delivery of Biopharmaceuticals.Pharmaceutics · 2023Review
- Thermosensitive Gels Used to Improve Microneedle-Assisted Transdermal Delivery of Naltrexone.Polymers · 2021Article
- Micropore Closure Rates following Microneedle Application at Various Anatomical Sites in Healthy Human Subjects.Skin pharmacology and physiology · 2021Article
- Microneedle for transdermal drug delivery: current trends and fabrication.Journal of pharmaceutical investigation · 2021Review
- The Current Status of Clinical Research Involving Microneedles: A Systematic Review.Pharmaceutics · 2020Review
- Micropore closure time is longer following microneedle application to skin of color.Scientific reports · 2020Article
- Design and Characterization of Spray-Dried Chitosan-Naltrexone Microspheres for Microneedle-Assisted Transdermal Delivery.Pharmaceutics · 2020Article
- Development of Hydrogels for Microneedle-Assisted Transdermal Delivery of Naloxone for Opioid-Induced Pruritus.Journal of pharmaceutical sciences · 2019Article
- Effect of dosing regimen and microneedle pretreatment on in vitro skin retention of topically applied beta-blockers.Biomedical microdevices · 2018Article
- Mini-Review: Assessing the Potential Impact of Microneedle Technologies on Home Healthcare Applications.Medicines (Basel, Switzerland) · 2018Review
- Optimization of impedance spectroscopy techniques for measuring cutaneous micropore formation after microneedle treatment in an elderly population.Pharmaceutical research · 2014Article
- Single compartment drug delivery.Journal of controlled release : official journal of the Controlled Release Society · 2014Review
- Hydrogel-forming microneedles increase in volume during swelling in skin, but skin barrier function recovery is unaffected.Journal of pharmaceutical sciences · 2014Article
- Skin permeabilization for transdermal drug delivery: recent advances and future prospects.Expert opinion on drug delivery · 2014Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 1 country.
Funding
Abstract
purposeMicroneedles applied to the skin create micropores, allowing transdermal drug delivery of skin-impermeable compounds. The first human study with this technique demonstrated delivery of naltrexone (an opioid antagonist) for two to three days. Rapid micropore closure, however, blunts the delivery window. Application of diclofenac (an anti-inflammatory) allows seven days of naltrexone delivery in animals. The purpose of the current work was to demonstrate delivery of naltrexone for seven days following one microneedle treatment in humans.
methodsHuman subjects were treated with microneedles, diclofenac (or placebo), and naltrexone. Impedance measurements were used as a surrogate marker to measure micropore formation, and plasma naltrexone concentrations were measured for seven days post-microneedle application.
resultsImpedance dropped significantly from baseline to post-microneedle treatment, confirming micropore formation. Naltrexone was detected for seven days in Group 1 (diclofenac + naltrexone, n = 6), vs. 72 h in Group 2 (placebo + naltrexone, n = 2). At study completion, a significant difference in impedance was observed between intact and microneedle-treated skin in Group 1 (confirming the presence of micropores).
conclusionThis is the first study demonstrating week-long drug delivery after one microneedle application, which would increase patient compliance and allow delivery of therapies for chronic diseases.
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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.