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Lidocaine and Tetracaine Cream to Treat Postherpetic Neuralgia (PHN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00609323
Recruitment Status : Completed
First Posted : February 7, 2008
Last Update Posted : March 29, 2012
Sponsor:
Information provided by (Responsible Party):
ZARS Pharma Inc.

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Postherpetic Neuralgia Drug: lidocaine and tetracaine cream 7%/7% Drug: Placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, 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
Study Start Date : January 2008
Actual Primary Completion Date : July 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles

Arms and Interventions
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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 Name: Pliaglis™
Placebo Comparator: 2 Drug: Placebo
One treatment of up to 400 cm2 Cream applied for 60 minutes.


Outcome Measures
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Primary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00609323


Locations
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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
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Study Director: Medical Monitor ZARS Pharma
More Information
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Responsible Party: ZARS Pharma Inc.
ClinicalTrials.gov Identifier: NCT00609323    
Other Study ID Numbers: SCP-403
First Posted: February 7, 2008    Key Record Dates
Last Update Posted: March 29, 2012
Last Verified: March 2012
Keywords provided by ZARS Pharma Inc.:
Pain
postherpetic neuralgia
Additional relevant MeSH terms:
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Neuralgia
Neuralgia, Postherpetic
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Lidocaine
Tetracaine
Anesthetics, Local
 Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action