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

Healthy Clinical Trial

Official title:

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%.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04319926
• Other study ID #: SCI-LIDO-ADH-003
• Status: Completed
• Phase: Phase 1
• Start date: September 7, 2018
• Est. completion date: September 9, 2018

Study information

• Verified date: April 2024
• Source: Scilex Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 9, 2018
• Est. primary completion date: September 9, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Tissue Adhesions

Intervention

Drug:
• lidocaine topical system 1.8%
One topical system is applied to the subject's back for 12 hours.
• lidocaine patch 5%
One generic lidocaine patch is applied to the subject's back for 12 hours.

Locations

Country	Name	City	State
United States	AXIS Clinicals	Dilworth	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Scilex Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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