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

March 23, 2020 updated by: Scilex Pharmaceuticals, Inc.

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

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%).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Fair Lawn, New Jersey, United States, 07410
        • TKL Research, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lidocaine Patch (Sequence ABC)
Subjects received all three topical lidocaine products in Periods 1, 2, and 3. The sequence in which they received the lidocaine products was determined by random assignment. For subjects in Arm 1, 3 lidocaine 1.8% patches were applied in Period 1, and 3 lidocaine 5% patches were applied in Period 2, and 3 lidocaine 5% medicated plasters were applied in Period 3.
Drug: Lidocaine patch 1.8%
Three patches are applied to the subject's back for 12 hours.
Other Names:
  • ZTlido
  • Lidocaine topical system 1.8%
Drug: Lidocaine patch 5%
Three patches are applied to the subject's back for 12 hours.
Other Names:
  • Lidoderm
Drug: Lidocaine medicated plaster 5%
Three plasters are applied to the subject's back for 12 hours.
Other Names:
  • Versatis
Experimental: Lidocaine Patch (Sequence CAB)
Subjects received all three topical lidocaine products in Periods 1, 2, and 3. The sequence in which they received the lidocaine products was determined by random assignment. For subjects in Arm 2, 3 lidocaine 5% medicated plasters were applied in Period 1, and 3 lidocaine 1.8% patches were applied in Period 2, and 3 lidocaine 5% patches were applied in Period 3.
Drug: Lidocaine patch 1.8%
Three patches are applied to the subject's back for 12 hours.
Other Names:
  • ZTlido
  • Lidocaine topical system 1.8%
Drug: Lidocaine patch 5%
Three patches are applied to the subject's back for 12 hours.
Other Names:
  • Lidoderm
Drug: Lidocaine medicated plaster 5%
Three plasters are applied to the subject's back for 12 hours.
Other Names:
  • Versatis
Experimental: Lidocaine Patch (Sequences BCA)
Subjects received all three topical lidocaine products in Periods 1, 2, and 3. The sequence in which they received the lidocaine products was determined by random assignment. For subjects in Arm 3, 3 lidocaine 5% patches were applied in Period 1, and 3 lidocaine 5% medicated plasters were applied in Period 2, and 3 lidocaine 1.8% patches were applied in Period 3.
Drug: Lidocaine patch 1.8%
Three patches are applied to the subject's back for 12 hours.
Other Names:
  • ZTlido
  • Lidocaine topical system 1.8%
Drug: Lidocaine patch 5%
Three patches are applied to the subject's back for 12 hours.
Other Names:
  • Lidoderm
Drug: Lidocaine medicated plaster 5%
Three plasters are applied to the subject's back for 12 hours.
Other Names:
  • Versatis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Adhesion Score (FDA scale)
Time Frame: 12 hours post-dose
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
Mean Adhesion Score (EMA scale)
Time Frame: 12 hours post-dose
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12.5 and 14 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scilex Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2017

Primary Completion (Actual)

March 22, 2017

Study Completion (Actual)

March 22, 2017

Study Registration Dates

First Submitted

March 20, 2020

First Submitted That Met QC Criteria

March 23, 2020

First Posted (Actual)

March 24, 2020

Study Record Updates

Last Update Posted (Actual)

March 24, 2020

Last Update Submitted That Met QC Criteria

March 23, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCI-LIDO-ADH-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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