利多卡因
医学
麻醉
刺激
粘附
表面麻醉剂
局部麻醉剂
外科
皮肤病科
有机化学
化学
免疫学
作者
Jeffrey Gudin,Lynn R. Webster,Emileigh Greuber,Kip Vought,Kalpana Patel,Louis Kuritzky
摘要
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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