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

Scilex

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: lidocaine patch 5%; Drug: lidocaine topical system 1.8%

Study type: Interventional

Funder types: Industry

Identifiers

NCT04319926

SCI-LIDO-ADH-003

Details and patient eligibility

About

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%

Enrollment: 24 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, 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Lidocaine Patch (Sequence T1T2)

Experimental group

Description:

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.

Treatment:

Drug: lidocaine topical system 1.8%

Drug: lidocaine patch 5%

Lidocaine Patch (Sequence T2T1)

Experimental group

Description:

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.

Treatment:

Drug: lidocaine topical system 1.8%

Drug: lidocaine patch 5%