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

NCT04319926 | Completed Phase 1 FDA Drug

• 1 other identifier: SCI-LIDO-ADH-003
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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%

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Lidocaine Patch (Sequence T1T2)

EXPERIMENTAL

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%; Drug: lidocaine patch 5%

Lidocaine Patch (Sequence T2T1)

EXPERIMENTAL

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%; Drug: lidocaine patch 5%

Interventions

lidocaine topical system 1.8% DRUG

One topical system is applied to the subject's back for 12 hours.

Also known as: lidocaine patch 1.8%, ZTlido

Lidocaine Patch (Sequence T1T2); Lidocaine Patch (Sequence T2T1)

lidocaine patch 5% DRUG

One generic lidocaine patch is applied to the subject's back for 12 hours.

Lidocaine Patch (Sequence T1T2); Lidocaine Patch (Sequence T2T1)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Scilex Pharmaceuticals, Inc.: lead

Study Sites (1)

AXIS Clinicals

Dilworth, Minnesota, 56529, United States

Location

Related Publications (1)

• 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.

  PMID: 33654425 DERIVED

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Patrick Luger, MD

  AXIS Clinicals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: March 24, 2020
• Study Start: September 7, 2018
• Primary Completion: September 9, 2018
• Study Completion: September 9, 2018
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

US (1)