Lidocaine and Tetracaine Cream to Treat Postherpetic Neuralgia (PHN) - Full Text View

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:

MedlinePlus related topics: Shingles

Drug Information available for: Lidocaine hydrochloride Tetracaine Tetracaine hydrochloride Lidocaine

U.S. FDA Resources

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

ClinicalTrials.gov processed this record on March 02, 2015