Evaluation of the Depth and Duration of Anesthesia From Heated Lidocaine/Tetracaine (Synera®) Patches Compared With 5% Lidocaine (Lidoderm®) Patches Applied to Healthy Adult Volunteers

This will be a randomized, single-blind, active-controlled, two-period crossover study in adult volunteers to compare the duration and depth of anesthesia between Synera® and Lidoderm® patches when applied for 30 minutes and 4 hours. The study will include a Screening Visit, two Treatment Periods, and a Follow-Up Phone Contact.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Heated Lidocaine/Tetracaine Patch; Drug: 5% Lidocaine Patch

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • Lifetree Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion:

1. Subject is male or female 18-60 years of age, inclusive.
2. Subject is judged by the Investigator to be in generally good health at screening based upon the results of a medical history, physical examination, clinical laboratory profile, and 12-lead electrocardiogram (ECG).
3. Subject is willing to refrain from using any local topical preparations on the volar aspect of the forearms for 24 hours prior to each site visit.
4. Subject has normal, intact skin bilaterally at the antecubital area.

5. If female, must be of non-childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy or hysterectomy]) or must be using adequate contraception (practicing one of the following methods of birth control):

   • Total abstinence from sexual intercourse (minimum of one complete menstrual cycle before study entry),
   • A vasectomized partner,
   • Contraceptives (oral, parenteral, or transdermal) for 3 consecutive months prior to test product administration,
   • Intrauterine device (IUD), or
   • Double-barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream).
6. If female, must have a negative urine pregnancy test at Screening and at check-in of each Treatment Period.
7. Subject is willing to be blindfolded during the study and agrees to abide by all study restrictions and comply with all study procedures.
8. Able to fluently speak and understand English and be able to provide meaningful written informed consent for the study.

Exclusion:

1. Subject has clinically significant ECG abnormalities at screening.
2. Subject is currently receiving class I, II, or III anti-arrhythmic agents.
3. Subject has used over-the-counter (OTC) or prescription analgesics within 24 hours prior to either study period.
4. Subject has a known allergy or history of significant adverse reaction to any component of the treatment or related compounds.
5. Subject has a history of or active use or abuse of illicit drug substance or alcohol abuse.
6. Subject has a positive urine test result for drugs of abuse or a positive ethanol breath test at the Screening Visit or check-in to Treatment Visit 1.
7. Subject has active dermatological disease of any origin that may interfere with the ability to participate.
8. Subject has denuded or broken skin on either forearm.
9. Subject has a history of unstable peripheral/vascular disease and/or hypertensive vascular disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Synera® for 30min & Lidoderm® for 4 hours; Heated Lidocaine/Tetracaine (Synera®)applied to one forearm for either 30 minutes or 4 hours and a 5% Lidocaine (Lidoderm®) patch applied to the alternate forearm for the alternate time period.	Drug: Heated Lidocaine/Tetracaine Patch; Other Names: Synera® Patch; Drug: 5% Lidocaine Patch; Other Names: Lidoderm® Patch
Active Comparator: Lidoderm® for 30min & Synera® for 4 hours; Heated Lidocaine/Tetracaine (Synera®)applied to one forearm for either 30 minutes or 4 hours and a 5% Lidocaine (Lidoderm®) patch applied to the alternate forearm for the alternate time period.	Drug: Heated Lidocaine/Tetracaine Patch; Other Names: Synera® Patch; Drug: 5% Lidocaine Patch; Other Names: Lidoderm® Patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Depth of Anesthesia measured in mm via insertion of 21-gauge needle into the skin.	Approximately 5 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Duration of Anesthesia measured in sensory presence, absence, and thermal thresholds.	Approximately 5 months

Collaborators and Investigators

• Sponsor: CRI Lifetree
• Collaborators: Nuvo Research Inc.
• Investigators: Principal Investigator: Miroslav Backonja, MD, CRI Lifetree

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: September 17, 2012
• First Submitted That Met QC Criteria: September 19, 2012
• First Posted (Estimate): September 20, 2012

Study Record Updates

• Last Update Posted (Estimate): January 4, 2013
• Last Update Submitted That Met QC Criteria: January 2, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Evaluation; Anesthesia; Depth and Duration
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Tetracaine
• Other Study ID Numbers: LCR-07-01-101