Lidocaine and Tetracaine Cream to Treat Postherpetic Neuralgia (PHN)

March 22, 2012 updated by: ZARS Pharma Inc.

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • ZARS Pharma Clinical Site
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • ZARS Pharma Clinical Site. Reference: SCP-403
      • Winston Salem, North Carolina, United States, 27103
        • ZARS Pharma Clinical Site. Reference: SCP-403
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • ZARS Pharma Clinical Site
      • Oklahoma City, Oklahoma, United States, 73112
        • ZARS Pharma Clinical Site
    • Texas
      • San Antonio, Texas, United States, 78229
        • ZARS Pharma Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: lidocaine and tetracaine cream 7%/7%
One treatment of up to 400 cm2 Cream applied for 60 minutes.
Other Names:
  • Pliaglis™
Placebo Comparator: 2
Drug: Placebo
One treatment of up to 400 cm2 Cream applied for 60 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: 24 hours after treatment
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
1-2 weeks between study treatments
Intensity of allodynia
Time Frame: Baseline, 4 hours, 9 hours, 24 hours after treatment
Baseline, 4 hours, 9 hours, 24 hours after treatment
Patient global impression of change.
Time Frame: 9 & 24 hours after treatment
9 & 24 hours after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ZARS Pharma Inc.

Investigators

  • Study Director: Medical Monitor, ZARS Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

January 18, 2008

First Submitted That Met QC Criteria

January 24, 2008

First Posted (Estimate)

February 7, 2008

Study Record Updates

Last Update Posted (Estimate)

March 29, 2012

Last Update Submitted That Met QC Criteria

March 22, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCP-403

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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