Clinical trial NCT00609323: Lidocaine and Tetracaine Cream to Treat Postherpetic Neuralgia (PHN)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postherpetic Neuralgia
Keywords: Pain
postherpetic neuralgia
Lead sponsor: ZARS Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2008-02-07
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

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 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.

Primary outcomes:
measure: 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.
timeFrame: 24 hours after treatment
measure: Area of allodynia will be mapped at baseline and at the treatment sessions.
timeFrame: 1-2 weeks between study treatments
measure: Intensity of allodynia
timeFrame: Baseline, 4 hours, 9 hours, 24 hours after treatment
measure: Patient global impression of change.
timeFrame: 9 & 24 hours after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: ZARS Pharma Clinical Site
state: Kentucky
city: High Point
country: United States
facility: ZARS Pharma Clinical Site. Reference: SCP-403
state: North Carolina
city: Winston Salem
country: United States
facility: ZARS Pharma Clinical Site. Reference: SCP-403
state: North Carolina
city: Norman
country: United States
facility: ZARS Pharma Clinical Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: ZARS Pharma Clinical Site
state: Oklahoma
city: San Antonio
country: United States
facility: ZARS Pharma Clinical Site
state: Texas
Study officials:
affiliation: ZARS Pharma
name: Medical Monitor
role: STUDY_DIRECTOR
References: