Overview

New Topical Treatment for Continued Pain After Shingles

Status:
Completed
Trial end date:
2008-09-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Biomedical Development Corporation
Collaborators:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
The University of Texas Health Science Center, Houston
Treatments:
Anesthetics
Anesthetics, Local
Aspirin
Lidocaine
Criteria
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