Lidocaine and Tetracaine Cream to Treat Postherpetic Neuralgia (PHN)

Phase 2

Completed

• Conditions: Postherpetic Neuralgia
• Interventions: Drug: Placebo; Drug: lidocaine and tetracaine cream 7%/7%

• Registration Number: NCT00609323
• Lead Sponsor: ZARS Pharma Inc.

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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-18
• Study First Submitted QC: 2008-01-24
• Study First Posted: 2008-02-07
• Primary Completion: 2008-07
• Study Completion: 2008-09
• Status Verified: 2012-03
• Disposition First Submitted: 2012-03-22
• Disposition First Submitted QC: 2012-03-22
• Last Update Submitted: 2012-03-22
• Disposition First Posted: 2012-03-29
• Last Update Posted: 2012-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Placebo	-
1	lidocaine and tetracaine cream 7%/7%	-

Primary Outcome Measures

Name	Time	Method
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
Area of allodynia will be mapped at baseline and at the treatment sessions.	1-2 weeks between study treatments
Intensity of allodynia	Baseline, 4 hours, 9 hours, 24 hours after treatment
Patient global impression of change.	9 & 24 hours after treatment

Trial Locations

Locations (2)

ZARS Pharma Clinical Site. Reference: SCP-403; 🇺🇸 Winston Salem, North Carolina, United States

ZARS Pharma Clinical Site; 🇺🇸 San Antonio, Texas, United States