Adhesion of Lidocaine Topical System 1.8%

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT04319926

Healthy

COMPLETED PHASE1

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

Healthy

COMPLETED PHASE1

Pharmacokinetics and Adhesion of Lidocaine Topical System 1.8% Under Conditions of Heat and Exercise

NCT04150536

Healthy

COMPLETED PHASE1

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

NCT04784728

Healthy

COMPLETED PHASE1

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

NCT05106400

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In this open-label, single-treatment, single-period, single-application adhesion performance study, 54 healthy, adult male and female subjects are treated with one lidocaine topical system to their back for 12 hours. Adhesion will be monitored throughout the wear time and skin irritation will be assessed after the topical system is removed.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lidocaine Patch

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.

Group Type EXPERIMENTAL

Lidocaine topical system 1.8%

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lidocaine topical system 1.8%

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Lidocaine patch 1.8% ZTlido

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

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
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes