Evaluate the Depth and Duration of Anesthesia

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: Synera™ Topical Patch (70 mg lidocaine/70 mg tetracaine); Drug: Placebo Patch

• Registration Number: NCT00891163
• Lead Sponsor: ZARS Pharma Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2009-04
• Study First Submitted: 2009-04-29
• Study First Submitted QC: 2009-04-30
• Last Update Submitted: 2009-04-30
• Study First Posted: 2009-05-01
• Last Update Posted: 2009-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Synera	Synera™ Topical Patch (70 mg lidocaine/70 mg tetracaine)	-
Placebo	Placebo Patch	-

Primary Outcome Measures

Name	Time	Method
Sensory and pain depth measurements	0, 30, 60, 90, 120 and 150 minutes
Dermal and thermal sensory testing evaluations	0, 30, 60, 90, 120 and 150 minutes

Secondary Outcome Measures

Name	Time	Method
Assess the safety and tolerability of the Synera topical patch compared with a matching heated placebo patch	Throughout the study
Evaluate local effects on the skin at the site of patch application for dermal adverse events (AEs)	Throughout the study

Trial Locations

Locations (1)

UCSD Medical Center, Thornton Hospital; 🇺🇸 San Diego, California, United States