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NCT Number: NCT00609323

Lidocaine and Tetracaine Cream to Treat Postherpetic Neuralgia (PHN)

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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Key information

Conditions

Postherpetic Neuralgia Nervous System Diseases Neuralgia Neuralgia, Postherpetic Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

ZARS Pharma Clinical Site, Lexington, Kentucky, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

lidocaine and tetracaine cream 7%/7%

Drug

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

Other names: Pliaglis™

Placebo

Drug

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

Primary outcomes

  1. 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.

    Time frame: 24 hours after treatment

  2. Area of allodynia will be mapped at baseline and at the treatment sessions.

    Time frame: 1-2 weeks between study treatments

  3. Intensity of allodynia

    Time frame: Baseline, 4 hours, 9 hours, 24 hours after treatment

  4. Patient global impression of change.

    Time frame: 9 & 24 hours after treatment

Sponsors and collaborators

Lead sponsor

ZARS Pharma Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Feb 7, 2008
Registry last updated
Mar 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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