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Clinical Adhesion Study Between ZTlido 1.8% and Three Over-the-counter External Analgesic Lidocaine-containing Patches

NCT05106400 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-11-03

No results posted yet for this study

Summary

The study is designed to evaluate and compare the clinical adhesion performance of the ZTlido (Lidocaine Topical System) 1.8% of Scilex Pharmaceuticals Inc. (Reference) versus Salonpas (Lidocaine Patch 4%), Aspercreme (Lidocaine Patch 4%) and IcyHot (Lidocaine 4% + Menthol 1% Patch), on the Mid to upper back while being worn for 12 hours in healthy adult human subjects.

Conditions

  • Healthy

Interventions

DRUG

ZTlido (Lidocaine Topical System) 1.8%

1 ZTlido (Lidocaine Topical System) 1.8% is applied predetermined area on the right or left side of the mid to upper back and worn for 12 hours

DRUG

Salonpas (Lidocaine Patch 4%)

1 Salonpas (Lidocaine Patch 4%) is applied predetermined area on the right or left side of the mid to upper back and worn for 12 hours

DRUG

Aspercreme (Lidocaine Patch 4%)

1 Aspercreme (Lidocaine Patch 4%) is applied predetermined area on the right or left side of the mid to upper back and worn for 12 hours

DRUG

IcyHot (Lidocaine 4% + Menthol 1% Patch)

1 IcyHot (Lidocaine 4% + Menthol 1% Patch) is applied predetermined area on the right or left side of the mid to upper back and worn for 12 hours

Sponsors & Collaborators

  • Scilex Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Dmitri Lissin, MD · Chief Medical Officer

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2021-07-21
Completion
2021-07-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05106400 on ClinicalTrials.gov