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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: lidocaine topical system 1.8%; Drug: lidocaine patch 5%

• Registration Number: NCT04319926
• Lead Sponsor: Scilex Pharmaceuticals, Inc.

Brief Summary

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%

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-07
• Primary Completion: 2018-09-09
• Study Completion: 2018-09-09
• Study First Submitted: 2020-03-20
• Study First Submitted QC: 2020-03-23
• Study First Posted: 2020-03-24
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lidocaine Patch (Sequence T1T2)	lidocaine topical system 1.8%	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.
Lidocaine Patch (Sequence T1T2)	lidocaine patch 5%	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.
Lidocaine Patch (Sequence T2T1)	lidocaine topical system 1.8%	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.
Lidocaine Patch (Sequence T2T1)	lidocaine patch 5%	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.

Primary Outcome Measures

Name	Time	Method
Mean Percent Adhesion	12 hours post-dose	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.

Trial Locations

Locations (1)

AXIS Clinicals; 🇺🇸 Dilworth, Minnesota, United States