ArticleJournal of pain research2021
A Randomized, Crossover, Adhesion Performance and Pharmacokinetic Study of a Lidocaine Topical System Under Conditions of Water Exposure in Healthy Subjects.
Article in Journal of pain research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04784728 (A Phase 1, Open Label, Randomized, Three-treatment, Three-sequence, Three-period, Crossover Adhesion Performance and Pharmacokinetic Study of Lidocaine Topical System 1.8% in Healthy, Adult Subjects Under Normal and Two Water Stress Conditions), which is not on this map. Cited by 2 papers.
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, Open Label, Randomized, Three-treatment, Three-sequence, Three-period, Crossover Adhesion Performance and Pharmacokinetic Study of Lidocaine Topical System 1.8% in Healthy, Adult Subjects Under Normal and Two Water Stress Conditions
Who cites it
2 citing papers in PubMed.
- Multimodal Therapies for the Treatment of Neuropathic Pain: The Role of Lidocaine Patches in Combination Therapy: A Narrative Review.Pain and therapy · 2025Review
- Open-Label Adhesion Performance Study of a Prescription Lidocaine Topical System 1.8% versus Three Lidocaine-Containing Over-the-Counter Patches in Healthy Subjects.Journal of pain research · 2022Article
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.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThis study compares the adhesion performance, pharmacokinetic profile, and safety of lidocaine topical system 1.8%, which is approved to treat postherpetic neuralgia, under conditions of swimming and showering versus normal conditions. PATIENTS AND
methodsThis open-label, 3-period, 3-treatment crossover study randomized 24 healthy adults to receive one lidocaine topical system during each of three treatment periods; subjects either swam in a heated swimming pool for 15 minutes 4.0 hours post-product application (swimming), showered for 10 minutes 8.0 hours after product application (showering), or the product remained dry throughout the treatment period (normal conditions). The product was applied to the mid-upper back and was removed after 12 hours. The pharmacokinetic profile of each subject under water exposure conditions was compared to subjects under normal conditions. Skin irritation, adhesion, and adverse events were assessed.
resultsTwenty-four (24) subjects enrolled and 23 completed the study. Exposure to water resulted in lifting of the topical systems. There were two complete detachments, as well as seven occurrences of major lifting (more than 50% detached) after water exposure. The topical systems were immediately pressed down and/or reapplied after observing lifting and remained adhered to for the rest of the 12-hour application period. No clinically relevant differences in systemic absorption were observed under either showering or swimming conditions. The topical systems were well tolerated, with only mild adverse events, none leading to discontinuation.
conclusionThese data show that while water exposure can cause the topical system to lift or detach, the lidocaine topical system 1.8% is capable of being reapplied and maintains adhesion for up to 12 hours of wear with no clinically significant changes in drug delivery. CLINICALTRIALSGOV: NCT04784728.
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