Adhesion of Lidocaine Topical System 1.8%

NCT04312750 | Completed Phase 1 FDA Drug

• 1 other identifier: SCI-LIDO-ADH-001
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to evaluate the adhesion performance of ZTlido (lidocaine topical system) 1.8% in normal, healthy volunteers.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Mean Cumulative Adhesion Score

  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.

  0, 3, 6, 9, 12 hours post-dose

Secondary Outcomes (1)

• Dermal Response Score

  12.5 and 14 hours post-dose

Study Arms (1)

Lidocaine Patch

EXPERIMENTAL

All subjects received one lidocaine topical system, which was applied to a predetermined fixed area on subject's left side of the back or right side of the back (lower/mid back) according to randomization schedule and worn for 12 hours.

Drug: Lidocaine topical system 1.8%

Interventions

Lidocaine topical system 1.8% DRUG

Also known as: Lidocaine patch 1.8%, ZTlido

Lidocaine Patch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Scilex Pharmaceuticals, Inc.: lead

Related Publications (1)

• Gudin J, Webster LR, Greuber E, Vought K, Patel K, Kuritzky L. Open-Label Adhesion Performance Studies of a New Lidocaine Topical System 1.8% versus Lidocaine Patches 5% and Lidocaine Medicated Plaster 5% in Healthy Subjects. J Pain Res. 2021 Feb 23;14:513-526. doi: 10.2147/JPR.S287153. eCollection 2021.

  PMID: 33654425 DERIVED

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Anthony Godfrey, PharmD

  AXIS Clinicals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 18, 2020
• Study Start: December 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 18, 2020

Record last verified: 2020-03