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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Heated Lidocaine/Tetracaine Patch; Drug: 5% Lidocaine Patch

• Registration Number: NCT01688518
• Lead Sponsor: CRI Lifetree

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-17
• Study First Submitted QC: 2012-09-19
• Study First Posted: 2012-09-20
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-02
• Last Update Posted: 2013-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Synera® for 30min & Lidoderm® for 4 hours	Heated Lidocaine/Tetracaine Patch	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.
Lidoderm® for 30min & Synera® for 4 hours	Heated Lidocaine/Tetracaine Patch	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.
Lidoderm® for 30min & Synera® for 4 hours	5% Lidocaine Patch	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.
Synera® for 30min & Lidoderm® for 4 hours	5% Lidocaine Patch	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Duration of Anesthesia measured in sensory presence, absence, and thermal thresholds.	Approximately 5 months

Trial Locations

Locations (1)

Lifetree Clinical Research; 🇺🇸 Salt Lake City, Utah, United States