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

NCT ID: NCT04320173

Last Updated: 2020-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-14
• Study Completion Date: 2017-03-22

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Lidocaine patch 1.8%

Intervention Type: DRUG

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

Lidocaine patch 5%

Intervention Type: DRUG

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

Lidocaine medicated plaster 5%

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Lidocaine patch 1.8%

Intervention Type: DRUG

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

Lidocaine patch 5%

Intervention Type: DRUG

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

Lidocaine medicated plaster 5%

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Lidocaine patch 1.8%

Intervention Type: DRUG

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

Lidocaine patch 5%

Intervention Type: DRUG

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

Lidocaine medicated plaster 5%

Intervention Type: DRUG

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

Interventions

Lidocaine patch 1.8%

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

Intervention Type: DRUG

Lidocaine patch 5%

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

Intervention Type: DRUG

Lidocaine medicated plaster 5%

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

Intervention Type: DRUG

Other Intervention Names

Lidocaine topical system 1.8%; ZTlido; Lidoderm; Versatis

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Scilex Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Phillip LaStella, MD

Role: PRINCIPAL_INVESTIGATOR

TKL Research, Inc.

Locations

TKL Research, Inc.

Fair Lawn, New Jersey, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33654425 (View on PubMed)

Other Identifiers

SCI-LIDO-ADH-002

Identifier Type: -

Identifier Source: org_study_id