Lidocaine and Tetracaine Cream to Treat Postherpetic Neuralgia (PHN)

Overview

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 Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 2008

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: 1
  • Placebo Comparator: 2

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • Area of allodynia will be mapped at baseline and at the treatment sessions.
    • Time Frame: 1-2 weeks between study treatments
  • Intensity of allodynia
    • Time Frame: Baseline, 4 hours, 9 hours, 24 hours after treatment
  • Patient global impression of change.
    • Time Frame: 9 & 24 hours after treatment

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • ZARS Pharma Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Monitor, Study Director, ZARS Pharma

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