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

An Open Label, Randomized, Two-treatment, Two-period, Single-dose Study Evaluating the Product Adhesion in Healthy, Adult Subjects Using ZTlido 1.8% Topical System and a Generic Lidocaine Patch 5%.

An open label, randomized, two-treatment, two-period, single-dose study evaluating the product adhesion in healthy, adult subjects using ZTlido 1.8% Topical System and a generic Lidocaine Patch 5%

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: lidocaine topical system 1.8%; Drug: lidocaine patch 5%

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Dilworth, Minnesota, United States, 56529
      • Axis Clinicals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Key Inclusion Criteria:

• Must be healthy based on by medical history, laboratory work, ECG, and physical exam with BMI range between 18.00 and 30.00 kg/m2 inclusive.
• Be at least 18 years of age
• If childbearing potential, use of acceptable form of birth control
• In the case of females of childbearing potential, have a negative serum pregnancy test

Key Exclusion Criteria:

• Allergy or known hypersensitivity to lidocaine, amide-type local anesthetics, or any component of the product formulation
• Any major medical illness 3 months prior or any significant history or ongoing chronic medical illness
• Subjects with conditions that might affect application of the product or its adhesive properties (including psoriasis, eczema, atopic dermatitis, damaged or irritated epidermal layer, and excessive hair or oil on the skin)
• History of addiction, abuse, and misuse of any drug
• Use of local anesthetics of antiarrhythmic drugs (such as tocainide or mexiletine) within 14 days prior to product application

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lidocaine Patch (Sequence T1T2); Subjects receive both lidocaine topical system 1.8% and the generic lidocaine patch 5%. The sequence in which they receive the lidocaine products is determined by random assignment. For subjects in Arm 1, lidocaine 1.8% topical systems are applied in Period 1, and the generic lidocaine 5% patches are applied in Period 2.	Drug: lidocaine topical system 1.8%; One topical system is applied to the subject's back for 12 hours.; Other Names: lidocaine patch 1.8%; ZTlido; Drug: lidocaine patch 5%; One generic lidocaine patch is applied to the subject's back for 12 hours.
Experimental: Lidocaine Patch (Sequence T2T1); Subjects receive both lidocaine topical system 1.8% and the generic lidocaine patch 5%. The sequence in which they receive the lidocaine products is determined by random assignment. For subjects in Arm 2, generic lidocaine 5% patches are applied in Period 1, and the lidocaine 1.8% topical systems are applied in Period 2.	Drug: lidocaine topical system 1.8%; One topical system is applied to the subject's back for 12 hours.; Other Names: lidocaine patch 1.8%; ZTlido; Drug: lidocaine patch 5%; One generic lidocaine patch is applied to the subject's back for 12 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Percent Adhesion	Percent adhesion is assessed by laying a transparent sheet the exact size of the product over the top of the product and outlining areas of adhesion with a marker on the transparent sheet. The area excluded from the adhered area will be assessed to determine the degree of lift-off. Adhesion is assessed every 3 hours after product application. Mean percent adhesion is calculated as the sum of scores at each assessment time point divided by the total number of observations.	12 hours post-dose

Collaborators and Investigators

• Sponsor: Scilex Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Patrick Luger, MD, Axis Clinicals

Publications and helpful links

General Publications

• Gudin J, Webster LR, Greuber E, Vought K, Patel K, Kuritzky L. 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. J Pain Res. 2021 Feb 23;14:513-526. doi: 10.2147/JPR.S287153. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2018
• Primary Completion (Actual): September 9, 2018
• Study Completion (Actual): September 9, 2018

Study Registration Dates

• First Submitted: March 20, 2020
• First Submitted That Met QC Criteria: March 23, 2020
• First Posted (Actual): March 24, 2020

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Tissue Adhesions; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: SCI-LIDO-ADH-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No