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

NCT04320173 | Completed Phase 1 FDA Drug

• 1 other identifier: SCI-LIDO-ADH-002
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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%).

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Dermal Response Score

  12.5 and 14 hours post-dose

Study Arms (3)

Lidocaine Patch (Sequence ABC)

EXPERIMENTAL

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%; Drug: Lidocaine patch 5%; Drug: Lidocaine medicated plaster 5%

Lidocaine Patch (Sequence CAB)

EXPERIMENTAL

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%; Drug: Lidocaine patch 5%; Drug: Lidocaine medicated plaster 5%

Lidocaine Patch (Sequences BCA)

EXPERIMENTAL

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%; Drug: Lidocaine patch 5%; Drug: Lidocaine medicated plaster 5%

Interventions

Lidocaine patch 1.8% DRUG

Three patches are applied to the subject's back for 12 hours.

Also known as: Lidocaine topical system 1.8%, ZTlido

Lidocaine Patch (Sequence ABC); Lidocaine Patch (Sequence CAB); Lidocaine Patch (Sequences BCA)

Lidocaine patch 5% DRUG

Three patches are applied to the subject's back for 12 hours.

Also known as: Lidoderm

Lidocaine Patch (Sequence ABC); Lidocaine Patch (Sequence CAB); Lidocaine Patch (Sequences BCA)

Lidocaine medicated plaster 5% DRUG

Three plasters are applied to the subject's back for 12 hours.

Also known as: Versatis

Lidocaine Patch (Sequence ABC); Lidocaine Patch (Sequence CAB); Lidocaine Patch (Sequences BCA)

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 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

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
• 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

Sponsors & Collaborators

• Scilex Pharmaceuticals, Inc.: lead

Study Sites (1)

TKL Research, Inc.

Fair Lawn, New Jersey, 07410, United States

Location

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; Lidoderm

Intervention Hierarchy (Ancestors)

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

Study Officials

• Phillip LaStella, MD

  TKL Research, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: March 24, 2020
• Study Start: February 14, 2017
• Primary Completion: March 22, 2017
• Study Completion: March 22, 2017
• Last Updated: March 24, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)