Open-Label Adhesion Performance Studies of a New Lidocaine Topical System 1.8% versus Lidocaine Patches 5% and Lidocaine Medicated Plaster 5% in Healthy Subjects
Authors Gudin J, Webster LR, Greuber E, Vought K, Patel K, Kuritzky L
Received 17 November 2020
Accepted for publication 16 January 2021
Published 23 February 2021 Volume 2021:14 Pages 513—526
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr Robert B. Raffa
Jeffrey Gudin,1,2 Lynn R Webster,3 Emileigh Greuber,4 Kip Vought,4 Kalpana Patel,4 Louis Kuritzky5
1Department of Anesthesiology, Rutgers New Jersey Medical School, Newark, NJ, USA; 2Department of Anesthesiology and Pain Management, Englewood Hospital and Medical Center, Englewood, NJ, USA; 3Scientific Affairs Neurosciences, PRA Health Sciences, Salt Lake City, UT, USA; 4Global Research and Development and Medical Affairs, Scilex Pharmaceuticals Inc, Palo Alto, CA, USA; 5Community Health and Family Medicine, University of Florida Community Health & Family Medicine, Gainesville, FL, USA
Correspondence: Lynn R Webster
Vice President Scientific Affairs, PRA Health Sciences, Salt Lake City, UT, 84103, USA
Tel +1 801 904 4593
Purpose: The primary objective was to evaluate adhesion performance of the lidocaine topical system 1.8% for 12 hours in healthy human subjects in three studies: as a single product (Study 1) and versus other lidocaine topical products (lidocaine patch 5% and lidocaine medicated plaster 5% [Study 2] and generic lidocaine patch 5% [Study 3]). Safety of the lidocaine topical system 1.8%, with a skin irritation focus, was a secondary objective.
Patients and Methods: All three studies were open-label, randomized, Phase 1 adhesion performance studies in healthy adult volunteers (N=125). Lidocaine topical products were applied for 12 hours per test, per study arm. Adhesion of all test products was scored at 0, 3, 6, 9, and 12 hours post-application. Skin irritation was scored after product removal or when a product detached.
Results: Overall, the majority (≥ 75%) of subjects treated with the lidocaine topical system 1.8% demonstrated ≥ 90% adhesion (FDA adhesion score 0) throughout the 12-hour administration period versus 13.6% of subjects treated with lidocaine patch 5%, 15.9% of subjects treated with lidocaine medicated plaster 5%, and 0% of subjects treated with the generic lidocaine patch 5%. There were no complete detachments with the lidocaine topical system 1.8%, whereas 4.5% of lidocaine patch 5% and lidocaine medicated plaster 5% detached, and 29% of generic lidocaine patch 5% detached. Minimal skin irritation was observed with each lidocaine topical product.
Conclusion: Across three studies, lidocaine topical system 1.8% demonstrated superior adhesion performance versus the three other products tested. Skin irritation was minimal across products and studies.
Clinicaltrials.gov: NCT04312750, NCT04320173, NCT04319926.
Keywords: lidocaine topical system, lidocaine patch, lidocaine medicated plaster, adhesion, postherpetic neuralgia
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