Lidocaine and Tetracaine Cream to Treat Postherpetic Neuralgia (PHN)

Postherpetic Neuralgia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00609323
• Other study ID #: SCP-403
• Status: Completed
• Phase: Phase 2
• First received: January 18, 2008
• Last updated: March 22, 2012
• Start date: January 2008
• Est. completion date: September 2008

Study information

• Verified date: March 2012
• Source: ZARS Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: September 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Neuralgia
• Neuralgia, Postherpetic
• Postherpetic Neuralgia

Intervention

Drug:
• lidocaine and tetracaine cream 7%/7%
One treatment of up to 400 cm2 Cream applied for 60 minutes.
• Placebo
One treatment of up to 400 cm2 Cream applied for 60 minutes.

Locations

Country	Name	City	State
United States	ZARS Pharma Clinical Site. Reference: SCP-403	High Point	North Carolina
United States	ZARS Pharma Clinical Site	Lexington	Kentucky
United States	ZARS Pharma Clinical Site	Norman	Oklahoma
United States	ZARS Pharma Clinical Site	Oklahoma City	Oklahoma
United States	ZARS Pharma Clinical Site	San Antonio	Texas
United States	ZARS Pharma Clinical Site. Reference: SCP-403	Winston Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
ZARS Pharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		24 hours after treatment	No
Primary	Area of allodynia will be mapped at baseline and at the treatment sessions.		1-2 weeks between study treatments	No
Primary	Intensity of allodynia		Baseline, 4 hours, 9 hours, 24 hours after treatment	No
Primary	Patient global impression of change.		9 & 24 hours after treatment	No