NCT04320173

Adhesion Performance Study of Lidocaine Topical System 1.8% Compared to Lidocaine Patch 5% and Lidocaine Medicated Plaster 5% in Healthy, Adult, Human Subjects

An Open Label, Three-period, Single-application, Adhesion Performance Study ZTlido® (Lidocaine Topical System) 1.8% Compared to Lidoderm® (Lidocaine Patch 5%) and Versatis® (Lidocaine Medicated Plaster 5%) in Healthy, Adult, Human Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Scilex Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study was to evaluate the adhesion performance of ZTlido® (lidocaine topical system) 1.8% compared to adhesion performance for Lidoderm® (lidocaine patch 5%) and Versatis® (lidocaine medicated plaster 5%).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Lidocaine patch 1.8%	Three patches are applied to the subject's back for 12 hours.
DRUG	Lidocaine patch 5%	Three patches are applied to the subject's back for 12 hours.
DRUG	Lidocaine medicated plaster 5%	Three plasters are applied to the subject's back for 12 hours.

Timeline

• Start date: 2017-02-14
• Primary completion: 2017-03-22
• Completion: 2017-03-22
• First posted: 2020-03-24
• Last updated: 2020-03-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study