Pain
Conditions
Keywords
Topical anesthesia, Analgesia
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.
Interventions
DRUGSynera™ Topical Patch (70 mg lidocaine/70 mg tetracaine)
30 minute applicable on antecubital fossa
DRUGPlacebo Patch
placebo
Sponsors
Endo Pharmaceuticals
ZARS Pharma Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed