Adhesion of Lidocaine Topical System 1.8%

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

Detailed Description
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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.

Official Title
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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.

Conditions
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Healthy

Intervention / Treatment
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* Drug: Lidocaine topical system 1.8%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine Patch<br>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. | Drug: Lidocaine topical system 1.8%<br> <br> * Other names: ZTlido;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |