Adhesion of Lidocaine Topical System 1.8%

Scilex

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Lidocaine topical system 1.8%

Study type: Interventional

Funder types: Industry

Identifiers

NCT04312750

SCI-LIDO-ADH-001

Details and patient eligibility

About

The objective of this study is to evaluate the adhesion performance of ZTlido (lidocaine topical system) 1.8% in normal, healthy volunteers.

Full description

In this open-label, single-treatment, single-period, single-application adhesion performance study, 54 healthy, adult male and female subjects are treated with one lidocaine topical system to their back for 12 hours. Adhesion will be monitored throughout the wear time and skin irritation will be assessed after the topical system is removed.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Must be healthy based on by medical history, laboratory work, and physical exam
• 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 1 patient group

Lidocaine Patch

Experimental group

Description:

All subjects received one lidocaine topical system, which was applied to a predetermined fixed area on subject's left side of the back or right side of the back (lower/mid back) according to randomization schedule and worn for 12 hours.

Treatment:

Drug: Lidocaine topical system 1.8%