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Completed

NCT Number: NCT04784728

Pharmacokinetics and Adhesion of Lidocaine Topical System 1.8% With Water Exposure

The objectives of this study are to evaluate the adhesion performance and pharmacokinetics of ZTlido (lidocaine topical system) 1.8% during swimming, showering, and under normal conditions.

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

AXIS Clinicals

Dilworth, Minnesota, 56529, United States

About this study

In this Phase 1, open-label, three-period crossover study, 24 healthy, adult male and female subjects are randomized to 1 of 3 treatment sequences. During each treatment period, subjects have one lidocaine topical system applied to their back for 12 hours with a 4-day washout between treatments. In each treatment period, the subject will either swim (Treatment A), shower (Treatment B), or refrain from these activities (Treatment C) while wearing the topical system. Blood samples for lidocaine PK will be collected pre-dose until 24 hours. Adhesion will be monitored throughout the wear time and skin irritation will be assessed 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 medical history, laboratory work, and physical exam
  • Body mass index ranging between 18.0-30.0 kg/m2, inclusive
  • Capable of unaided swimming
  • If childbearing potential, use of acceptable form of birth control
  • In case of females of childbearing potential, have a negative serum pregnancy

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 affecting the major body systems, including the skin
  • 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)
  • Use of antiarrhymthic drugs (such as tocainide and mexiletine) and local anesthetics within 14 days prior to product application.
  • History of addiction, abuse, or misuse of any drug
  • Use of nicotine-containing products within 30 days

Treatment and study plan

lidocaine topical system 1.8%

Drug

lidocaine patch

Other names: ZTlido

Primary outcomes

  1. Mean cumulative adhesion score

    Time frame: Over 12 hours

    Adhesion to skin assessed by FDA 0-4 scoring system. The scoring for adhesion of patches 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 cumulative adhesion score is calculated as the sum of scores at each assessment time point (3, 4.5, 7, 8.5, and 12 hours).

Secondary outcomes

  1. Peak plasma concentration (Cmax) of lidocaine

    Time frame: 0, 1.5, 3.0, 6.0, 9.0, 12.0, 15.0, 18.0, 24.0 hours post-dose

    Peak plasma concentration of lidocaine after product application for 12 hours

  2. Area under the plasma concentration-time curve (AUC) from Time 0 to Time 24 hours

    Time frame: 0, 1.5, 3.0, 6.0, 9.0, 12.0, 15.0, 18.0, 24.0 hours post-dose

    Area under the plasma concentration versus time curve from 0 to 24 hours of lidocaine in plasma

  3. Area under the plasma concentration-time curve (AUC) from Time 0 to Time Infinity

    Time frame: 0, 1.5, 3.0, 6.0, 9.0, 12.0, 15.0, 18.0, 24.0 hours post-dose

    Area under the plasma concentration versus time curve from 0 to infinite time of lidocaine in plasma

  4. 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

A Phase 1, Open Label, Randomized, Three-treatment, Three-sequence, Three-period, Crossover Adhesion Performance and Pharmacokinetic Study of Lidocaine Topical System 1.8% in Healthy, Adult Subjects Under Normal and Two Water Stress Conditions

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 5, 2021
Registry last updated
Mar 5, 2021

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.

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