Lidocaine and Tetracaine Cream to Treat Postherpetic Neuralgia (PHN)

NCT00609323 | Completed Phase 2

• 1 other identifier: SCP-403
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 6

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).

Conditions

Postherpetic Neuralgia

Keywords

Pain; postherpetic neuralgia

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

1

EXPERIMENTAL

Drug: lidocaine and tetracaine cream 7%/7%

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

lidocaine and tetracaine cream 7%/7% DRUG

One treatment of up to 400 cm2 Cream applied for 60 minutes.

Also known as: Pliaglis™

1

Placebo DRUG

One treatment of up to 400 cm2 Cream applied for 60 minutes.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of PHN.
• Painful PHN areas not located on the face, eye, or in the hair.
• At least 3 months post-vesicle crusting.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ZARS Pharma Inc.: lead

Study Sites (6)

ZARS Pharma Clinical Site

Lexington, Kentucky, 40503, United States

Location

ZARS Pharma Clinical Site. Reference: SCP-403

High Point, North Carolina, 27262, United States

Location

ZARS Pharma Clinical Site. Reference: SCP-403

Winston-Salem, North Carolina, 27103, United States

Location

ZARS Pharma Clinical Site

Norman, Oklahoma, 73069, United States

Location

ZARS Pharma Clinical Site

Oklahoma City, Oklahoma, 73112, United States

Location

ZARS Pharma Clinical Site

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Neuralgia, Postherpetic; Pain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Medical Monitor

  ZARS Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2008
• First Posted: February 7, 2008
• Study Start: January 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: September 1, 2008
• Last Updated: March 29, 2012

Record last verified: 2012-03

Locations

US (6)