New Topical Treatment for Continued Pain After Shingles

Phase 1 Novel Topical Treatment for Post-herpetic Neuralgia

Shingles is an outbreak of rash or blisters on the skin that is caused by the same virus that causes chicken pox. Some people experience continued pain even after the shingles rash and blisters have healed; this pain is known as postherpetic neuralgia. The purpose of this study is to evaluate the effectiveness of a new topical treatment for postherpetic neuralgia in adults.

Study Overview

• Status: Completed
• Conditions: Postherpetic Neuralgia
• Intervention / Treatment: Drug: Epikeia coatings with aspirin; Drug: Epikeia coatings with lidocaine; Other: Epikeia coatings alone

Detailed Description

After an initial infection of chicken pox, the varicella-zoster virus can remain dormant inside nerve cells. Years later, the virus can be reactivated, causing a repeat outbreak called shingles. The first symptom of shingles is usually a burning or tingling pain in one particular location and on one side of the body. This pain can range from mild to severe. Other possible symptoms of shingles include numbness and itching. After several days or 1 week, a rash of fluid-filled blisters similar to chicken pox appears. For most healthy people, a case of shingles heals within a month. However, some people continue to feel pain after the rash and blisters have resolved; this pain is known as postherpetic neuralgia. Current treatments for postherpetic neuralgia include antiviral drugs, steroids, antidepressants, anticonvulsants, and topical products. A new topical treatment consists of a liquid product that is applied directly to the skin to let dry and form a thin, transparent barrier film. In contrast to creams or ointments that can stay in contact with skin for only minutes, this product remains intact on the skin for many hours, providing sustained delivery of a drug or medication while maintaining barrier protection for the skin. The purpose of this study is to evaluate the effectiveness of this new topical treatment for postherpetic neuralgia in adults.

This study will last about 3 weeks and will include seven study visits on Days 1, 8, 9, 15, 16, 22, and 23. All study visits will include questionnaires on pain levels and an examination and digital photos of the affected skin area. The study visit on Day 1 will also include a urine pregnancy test and a review of medical and medication history. During the study visits on Days 8, 15, and 22, one of three topical products will be applied to participants' affected skin. The product will dry on the skin in 30 to 45 seconds. Participants will then wait at the study site for 1.5 hours, after which they will record the time when they experienced pain relief. At each of these three treatment visits, participants will receive one of the following three topical products: Epikeia coatings with aspirin, Epikeia coatings with local anesthetic, and Epikeia coatings alone. At these three study visits, questionnaires, examinations, and digital photographs will occur both before and after the products are applied to the skin. Throughout the study, participants will record their pain levels and medications in a diary, which will be reviewed at all study visits.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Dermatology Clincial Reseach Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• In good general health
• Postherpetic neuralgia, defined as pain persisting more than 4 months after onset of herpes zoster outbreak
• Willing to use effective forms of contraception for the duration of the study

Exclusion Criteria:

• Known lidocaine sensitivity or allergy
• Inability to discontinue use of any nonstudy lidocaine-containing products for the duration of the study
• Known hypersensitivity to aspirin
• Open herpes zoster blisters
• Known sensitivity or allergy to an amide-type local anesthetic agent
• Existing conditions that make participation unsafe
• Pregnant
• Immunocompromised (e.g., HIV infected)
• Herpes zoster in any dermatome (area of skin innervated by a specific sensory nerve) affecting the face or scalp
• Affected skin area is greater than 420 square cm
• Affected area includes skin breakdown or nonintact skin
• Affected area consists of more than one contiguous area

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 1; Participants will receive one of three different topical treatments on Days 8, 15, or 22.

Drug: Epikeia coatings with aspirin; Applied to affected skin area using a roll-on ball applicator; Other Names: Epikeia coatings with acetylsalicylic acid; Drug: Epikeia coatings with lidocaine; Applied to affected skin area using a roll-on ball applicator; Other Names: Epikeia coatings with local anesthetic; Other: Epikeia coatings alone; Applied to affected skin area using a roll-on ball applicator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Latency to analgesia onset and duration of analgesia measures	Between 8 and 16 hours after treatment application

Secondary Outcome Measures

Outcome Measure	Time Frame
Skin irritation potential	Between 8 and 24 hours after treatment application

Collaborators and Investigators

• Sponsor: Biomedical Development Corporation
• Collaborators: The University of Texas Health Science Center, Houston; National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Investigators: Principal Investigator: Adelaide A. Hebert, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: September 10, 2007
• First Submitted That Met QC Criteria: November 30, 2007
• First Posted (Estimate): December 4, 2007

Study Record Updates

• Last Update Posted (Estimate): August 31, 2011
• Last Update Submitted That Met QC Criteria: August 29, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: Shingles; PHN; Post-herpetic Neuralgia; Pain after Shingles
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Neuralgia, Postherpetic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Membrane Transport Modulators; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Aspirin; Anesthetics; Lidocaine; Anesthetics, Local
• Other Study ID Numbers: R43AR052998 (U.S. NIH Grant/Contract); 1R43AR052998-01 (U.S. NIH Grant/Contract); HSC-MS-06-0352