Lidocaine and Tetracaine Cream to Treat Postherpetic Neuralgia (PHN)

Study Overview
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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).

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.

Official Title
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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

Conditions
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Postherpetic Neuralgia

Intervention / Treatment
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* Drug: lidocaine and tetracaine cream 7%/7%
* Drug: Placebo


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: lidocaine and tetracaine cream 7%/7%<br>* One treatment of up to 400 cm2 Cream applied for 60 minutes.<br>* Other names: Pliaglis™;|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* One treatment of up to 400 cm2 Cream applied for 60 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain will be rated using the Numeric Pain Rating Scale (NPRS). Patients will rate: Worst pain over the last 24 hours, Least pain over the last 24 hours, Average pain over the last 24 hours, Present pain intensity. |  | 24 hours after treatment | 
| Area of allodynia will be mapped at baseline and at the treatment sessions. |  | 1-2 weeks between study treatments | 
| Intensity of allodynia |  | Baseline, 4 hours, 9 hours, 24 hours after treatment | 
| Patient global impression of change. |  | 9 & 24 hours after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postherpetic neuralgia, Pain