Adhesion of Lidocaine Topical System 1.… | Clinical Trial

Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lidocaine topical system 1.8%

Drug

Other names: Lidocaine patch 1.8%, ZTlido

Primary outcomes

Mean Cumulative Adhesion Score

Time frame: 0, 3, 6, 9, 12 hours post-dose

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.

Secondary outcomes

Dermal Response Score

Time frame: 12.5 and 14 hours post-dose

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.

Sponsors and collaborators

Lead sponsor

Scilex Pharmaceuticals, Inc.

Industry

Registry information

Official study 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.

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Mar 18, 2020
Registry last updated: Mar 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed