NCT00609323

Lidocaine and Tetracaine Cream to Treat Postherpetic Neuralgia (PHN)

A Randomized, Double-Blind, Crossover Study Comparing Pliaglis™ (Lidocaine and Tetracaine) Cream 7%/7% to Placebo Cream When Applied for 60 Minutes in the Treatment of Patients With Postherpetic Neuralgia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: ZARS Pharma Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Pliaglis™ (lidocaine and tetracaine) Cream 7%/7% is a topical local anesthetic cream that forms a pliable peel on the skin when exposed to air. When applied to intact skin, Pliaglis provides local dermal analgesia by the release of lidocaine and tetracaine from the peel into the skin. Pliaglis is currently approved in the United States for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, and facial laser resurfacing. This study will evaluate lidocaine and tetracaine cream 7%/7% for the treatment of pain associated with postherpetic neuralgia (PHN).

Detailed description

The objectives of the study are 1) to compare the clinical efficacy of lidocaine and tetracaine cream 7%/7% with placebo cream in the treatment of neuropathic pain associated with postherpetic neuralgia (PHN) and 2) to monitor the nature and frequency of adverse events following a single, 60-minute application of lidocaine and tetracaine cream 7%/7% and placebo cream.

Conditions

• Postherpetic Neuralgia

Interventions

Type	Name	Description
DRUG	lidocaine and tetracaine cream 7%/7%	One treatment of up to 400 cm2 Cream applied for 60 minutes.
DRUG	Placebo	One treatment of up to 400 cm2 Cream applied for 60 minutes.

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-07-01
• Completion: 2008-09-01
• First posted: 2008-02-07
• Last updated: 2012-03-29

Locations

6 sites across 1 country: United States