Evaluate the Depth and Duration of Anesthesia

ZARS Pharma

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: Synera™ Topical Patch (70 mg lidocaine/70 mg tetracaine); Drug: Placebo Patch

Study type: Interventional

Funder types: Industry

Identifiers

NCT00891163

EN3274-101

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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25 participants in 2 patient groups, including a placebo group

Synera

Experimental group

Treatment:

Drug: Synera™ Topical Patch (70 mg lidocaine/70 mg tetracaine)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo Patch