Open-Label Adhesion Performance Study of a Prescription Lidocaine Topical System 1.8% versus Three Lidocaine-Containing Over-the-Counter Patches in Healthy Subjects.

ABSTRACT:

Purpose

This study evaluates and compares the clinical adhesion performance of a prescription lidocaine topical system 1.8% versus two different over-the-counter (OTC) lidocaine patches 4% and an OTC combination menthol and lidocaine patch 1%/4% in human subjects.

Patients and methods

This study was an open-label, randomized, four-treatment, four-sequence, Phase 1 adhesion performance study in healthy adult volunteers (N = 24). Lidocaine topical system 1.8% (R) and the three OTC patch products (T1, T2, and T3) were separately applied for 12 hours. Adhesion of all products was scored at 0, 3, 6, 8, and 12 hours post-application.

Results

There were no issues with the conduct of the study. Overall, the majority (≥59.1%) of subjects treated ("patched") with the lidocaine

SUBMITTER: Fudin J 

PROVIDER: S-EPMC9341344 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature