Lidocaine and Tetracaine Cream to Treat Postherpetic Neuralgia (PHN)

ZARS Pharma

Status and phase

Completed

Phase 2

Conditions

Postherpetic Neuralgia

Treatments

Drug: lidocaine and tetracaine cream 7%/7%

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00609323

SCP-403

Details and patient eligibility

About

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).

Full 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.

Enrollment

23 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Clinical diagnosis of PHN.
Painful PHN areas not located on the face, eye, or in the hair.
At least 3 months post-vesicle crusting.

Exclusion criteria

Has broken skin at the target treatment site.
Is currently on certain prescription medications.
Doesn't meet criteria due to physical exam findings or medical history.
Female that is pregnant, breastfeeding, or of childbearing potential and not practicing adequate birth control.