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A Randomized, Crossover, Adhesion Performance and Pharmacokinetic Study of a Lidocaine Topical System Under Conditions of Water Exposure in Healthy Subjects
PURPOSE: This 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 METHODS: This open-label, 3-period, 3-trea...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Dove
2021
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8379683/ https://www.ncbi.nlm.nih.gov/pubmed/34429646 http://dx.doi.org/10.2147/JPR.S323789 |
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author | Vought, Kip Greuber, Emileigh Patel, Kalpana Argoff, Charles Lissin, Dmitri |
author_facet | Vought, Kip Greuber, Emileigh Patel, Kalpana Argoff, Charles Lissin, Dmitri |
author_sort | Vought, Kip |
collection | PubMed |
description | PURPOSE: This 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 METHODS: This 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. RESULTS: Twenty-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. CONCLUSION: These 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. CLINICALTRIALS.GOV: NCT04784728. |
format | Online Article Text |
id | pubmed-8379683 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Dove |
record_format | MEDLINE/PubMed |
spelling | pubmed-83796832021-08-23 A Randomized, Crossover, Adhesion Performance and Pharmacokinetic Study of a Lidocaine Topical System Under Conditions of Water Exposure in Healthy Subjects Vought, Kip Greuber, Emileigh Patel, Kalpana Argoff, Charles Lissin, Dmitri J Pain Res Original Research PURPOSE: This 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 METHODS: This 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. RESULTS: Twenty-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. CONCLUSION: These 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. CLINICALTRIALS.GOV: NCT04784728. Dove 2021-08-16 /pmc/articles/PMC8379683/ /pubmed/34429646 http://dx.doi.org/10.2147/JPR.S323789 Text en © 2021 Vought et al. https://creativecommons.org/licenses/by-nc/3.0/This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/ (https://creativecommons.org/licenses/by-nc/3.0/) ). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php). |
spellingShingle | Original Research Vought, Kip Greuber, Emileigh Patel, Kalpana Argoff, Charles Lissin, Dmitri A Randomized, Crossover, Adhesion Performance and Pharmacokinetic Study of a Lidocaine Topical System Under Conditions of Water Exposure in Healthy Subjects |
title | A Randomized, Crossover, Adhesion Performance and Pharmacokinetic Study of a Lidocaine Topical System Under Conditions of Water Exposure in Healthy Subjects |
title_full | A Randomized, Crossover, Adhesion Performance and Pharmacokinetic Study of a Lidocaine Topical System Under Conditions of Water Exposure in Healthy Subjects |
title_fullStr | A Randomized, Crossover, Adhesion Performance and Pharmacokinetic Study of a Lidocaine Topical System Under Conditions of Water Exposure in Healthy Subjects |
title_full_unstemmed | A Randomized, Crossover, Adhesion Performance and Pharmacokinetic Study of a Lidocaine Topical System Under Conditions of Water Exposure in Healthy Subjects |
title_short | A Randomized, Crossover, Adhesion Performance and Pharmacokinetic Study of a Lidocaine Topical System Under Conditions of Water Exposure in Healthy Subjects |
title_sort | randomized, crossover, adhesion performance and pharmacokinetic study of a lidocaine topical system under conditions of water exposure in healthy subjects |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8379683/ https://www.ncbi.nlm.nih.gov/pubmed/34429646 http://dx.doi.org/10.2147/JPR.S323789 |
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