Evaluate the Depth and Duration of Anesthesia

ZARS Pharma Inc.25 enrolled

Overview

The purpose of the study is to determine the depth (mm) of anesthesia provided by the Synera topical patch (using sensory depth and pain depth evaluations), and to determine the duration (minutes) of anesthesia provided by the Synera topical patch (using dermal sensory testing and thermal sensory testing evaluations), compared with a matching heated placebo patch.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pain

Interventions

Synera™ Topical Patch (70 mg lidocaine/70 mg tetracaine)DRUG

30 minute applicable on antecubital fossa

Placebo PatchDRUG

placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Had no known significant diseases * Normal 12-lead electrocardiogram * Willing to refrain from using any local topical preparations Exclusion Criteria: * Taken over-the-counter (OTC) or prescription analgesics in any form within 24 hours * Known allergy or sensitivity to any component of the Synera patch, including lidocaine, sympathomimetic amines, other local anesthetics of the amide type, epinephrine, or other patch components * Had an active dermatological disease of any origin that may have interfered with their ability to participate

Locations (1)

UCSD Medical Center, Thornton Hospital

San Diego, California, United States

Outcomes

Primary Outcomes

Sensory and pain depth measurements

Time frame: 0, 30, 60, 90, 120 and 150 minutes

Dermal and thermal sensory testing evaluations

Time frame: 0, 30, 60, 90, 120 and 150 minutes

Secondary Outcomes

Assess the safety and tolerability of the Synera topical patch compared with a matching heated placebo patch

Time frame: Throughout the study

Evaluate local effects on the skin at the site of patch application for dermal adverse events (AEs)

Time frame: Throughout the study

Data from ClinicalTrials.gov

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