Lidocaine and Tetracaine Cream to Treat Postherpetic Neuralgia (PHN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ZARS Pharma Inc.
ClinicalTrials.gov Identifier:
NCT00609323
First received: January 18, 2008
Last updated: March 22, 2012
Last verified: March 2012
  Purpose

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).


Condition Intervention Phase
Postherpetic Neuralgia
Drug: lidocaine and tetracaine cream 7%/7%
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by ZARS Pharma Inc.:

Primary Outcome 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 ] [ Designated as safety issue: No ]
  • Area of allodynia will be mapped at baseline and at the treatment sessions. [ Time Frame: 1-2 weeks between study treatments ] [ Designated as safety issue: No ]
  • Intensity of allodynia [ Time Frame: Baseline, 4 hours, 9 hours, 24 hours after treatment ] [ Designated as safety issue: No ]
  • Patient global impression of change. [ Time Frame: 9 & 24 hours after treatment ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: January 2008
Study Completion Date: September 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: lidocaine and tetracaine cream 7%/7%
One treatment of up to 400 cm2 Cream applied for 60 minutes.
Other Name: Pliaglis™
Placebo Comparator: 2 Drug: Placebo
One treatment of up to 400 cm2 Cream applied for 60 minutes.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00609323

Locations
United States, Kentucky
ZARS Pharma Clinical Site
Lexington, Kentucky, United States, 40503
United States, North Carolina
ZARS Pharma Clinical Site. Reference: SCP-403
High Point, North Carolina, United States, 27262
ZARS Pharma Clinical Site. Reference: SCP-403
Winston Salem, North Carolina, United States, 27103
United States, Oklahoma
ZARS Pharma Clinical Site
Norman, Oklahoma, United States, 73069
ZARS Pharma Clinical Site
Oklahoma City, Oklahoma, United States, 73112
United States, Texas
ZARS Pharma Clinical Site
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
ZARS Pharma Inc.
Investigators
Study Director: Medical Monitor ZARS Pharma
  More Information

No publications provided

Responsible Party: ZARS Pharma Inc.
ClinicalTrials.gov Identifier: NCT00609323     History of Changes
Other Study ID Numbers: SCP-403
Study First Received: January 18, 2008
Last Updated: March 22, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by ZARS Pharma Inc.:
Pain
postherpetic neuralgia

Additional relevant MeSH terms:
Neuralgia
Neuralgia, Postherpetic
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Lidocaine
Tetracaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014