Adhesion of Lidocaine Topical System 1.8%

Healthy Clinical Trial

Official title:

An Open Label, Single-treatment, Single-period, Single-application, Adhesion Performance Study of Lidocaine Patch 36 mg/Patch (1.8%) in Healthy, Adult, Human Subjects.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04312750
• Other study ID #: SCI-LIDO-ADH-001
• Status: Completed
• Phase: Phase 1
• Start date: December 2015
• Est. completion date: December 2015

Study information

• Verified date: March 2020
• Source: Scilex Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• 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, 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

Related Conditions & MeSH terms

• Healthy
• Tissue Adhesions

Intervention

Drug:
• Lidocaine topical system 1.8%

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Scilex Pharmaceuticals, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Cumulative Adhesion Score	Adhesion of the topical system to the skin is assessed by FDA 0-4 scoring system. The scoring for adhesion of topical systems is indicated as follows: 0 = = 90% Adhered (essentially no lift off the skin), 1 = = 75% to < 90% Adhered (some edges only lifting off the skin), 2 = = 50% to < 75% Adhered (less than half of the patch lifting off the skin), > 0% to < 50% Adhered but not detached (more than half of the patch lifting off the skin without falling off), and 4 = 0% adhered (patched completely detached). The mean cumulative adhesion score is calculated as the sum of scores at each assessment time point divided by the total number of observations.	0, 3, 6, 9, 12 hours post-dose
Secondary	Dermal Response Score	Product tolerability is assessed by Dermal Response Score. The application site is evaluated 30 minutes and 2 hours after product removal (12.5 and 14 hours post-dose, respectively). Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; minimal edema or minimal papular response, 3= Erythema and papules, 4= Definite edema, 5= Erythema, edema and papules, 6= Vesicular eruption, 7= Strong reaction spreading beyond test (i.e., application) site.	12.5 and 14 hours post-dose