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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
47

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 14, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 22, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 22, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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