Lidocaine and Tetracaine Cream to Treat Postherpetic Neuralgia (PHN)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-09-30

Brief Summary

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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).

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Detailed Description

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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

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Postherpetic Neuralgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

lidocaine and tetracaine cream 7%/7%

Intervention Type DRUG

One treatment of up to 400 cm2 Cream applied for 60 minutes.

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

One treatment of up to 400 cm2 Cream applied for 60 minutes.

Interventions

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lidocaine and tetracaine cream 7%/7%

One treatment of up to 400 cm2 Cream applied for 60 minutes.

Intervention Type DRUG

Placebo

One treatment of up to 400 cm2 Cream applied for 60 minutes.

Intervention Type DRUG

Other Intervention Names

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Pliaglis™

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No