Evaluate the Depth and Duration of Anesthesia

A Randomized, Double-Blind, Two-Period, Crossover Study to Evaluate the Depth and Duration of Anesthesia of Synera™ Patches Compared to Placebo Patches Applied to Healthy Adult Volunteers

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.

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