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

Healthy Clinical Trial

Official title:

An Open Label, Three-period, Single-application, Adhesion Performance Study ZTlido® (Lidocaine Topical System) 1.8% Compared to Lidoderm® (Lidocaine Patch 5%) and Versatis® (Lidocaine Medicated Plaster 5%) in Healthy, Adult, Human Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04320173
• Other study ID #: SCI-LIDO-ADH-002
• Status: Completed
• Phase: Phase 1
• Start date: February 14, 2017
• Est. completion date: March 22, 2017

Study information

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

Clinical Trial Summary

The primary objective of this study was to evaluate the adhesion performance of ZTlido® (lidocaine topical system) 1.8% compared to adhesion performance for Lidoderm® (lidocaine patch 5%) and Versatis® (lidocaine medicated plaster 5%).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: March 22, 2017
• Est. primary completion date: March 22, 2017
• 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 with BMI range between 18.00 and 30.00 kg/m2 inclusive.

• Non-smokers

• 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

• Presence of any current dermatological condition including psoriasis, eczema, and atopic dermatitis

• Presence of any skin condition such as scratches, cuts, scars, abrasions, excessive hair, tattoos, moles, recently shaved skin, uneven skin texture, irritated (e.g., redness, rash or having blister, etc.) or excessively oily skin at the application areas that may affect the application of the product or adhesion properties of the product.

• History of significant dermatologic cancers (e.g., melanoma, squamous cell carcinoma) except basal cell carcinomas that were superficial and do not involve the investigative site

• History of addiction, abuse, and misuse of any drug

Related Conditions & MeSH terms

• Healthy
• Tissue Adhesions

Intervention

Drug:
• Lidocaine patch 1.8%
Three patches are applied to the subject's back for 12 hours.
• Lidocaine patch 5%
Three patches are applied to the subject's back for 12 hours.
• Lidocaine medicated plaster 5%
Three plasters are applied to the subject's back for 12 hours.

Locations

Country	Name	City	State
United States	TKL Research, Inc.	Fair Lawn	New Jersey

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 Adhesion Score (FDA scale)	Adhesion of the product to the skin is assessed by the FDA 0-4 scoring system. The scoring for adhesion 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). Adhesion is assessed every 3 hours for 12 hours. The mean cumulative adhesion score is calculated as the sum of scores at each assessment time point divided by the total number of observations.	12 hours post-dose
Primary	Mean Adhesion Score (EMA scale)	Adhesion of the product to the skin is assessed by the EMA 0-6 scoring system. The scoring for adhesion is indicated as follows: 0 = < 70% Adhered, 1 = > 70% Adhered, 2 = > 75% Adhered, 3 = > 80% Adhered, 4 = > 85% Adhered, 5 = > 90% adhered, and 6 = > 95% Adhered. Adhesion is assessed every 3 hours for 12 hours. The mean cumulative adhesion score is calculated as the sum of scores at each assessment time point divided by the total number of observations.	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