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Sponsors and Collaborators: |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Biomedical Development Corporation The University of Texas Health Science Center, Houston |
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Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
ClinicalTrials.gov Identifier: | NCT00566904 |
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.
Condition | Intervention | Phase |
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Postherpetic Neuralgia |
Drug: Epikeia coatings with aspirin Drug: Epikeia coatings with lidocaine Other: Epikeia coatings alone |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Investigator), Uncontrolled, Crossover Assignment, Efficacy Study |
Official Title: | Phase 1 Novel Topical Treatment for Post-Herpetic Neuralgia |
Enrollment: | 30 |
Study Start Date: | September 2006 |
Study Completion Date: | September 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will receive one of three different topical treatments on Days 8, 15, or 22.
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Drug: Epikeia coatings with aspirin
Applied to affected skin area using a roll-on ball applicator
Drug: Epikeia coatings with lidocaine
Applied to affected skin area using a roll-on ball applicator
Other: Epikeia coatings alone
Applied to affected skin area using a roll-on ball applicator
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
Dermatology Clincial Reseach Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Adelaide A. Hebert, MD | The University of Texas Health Science Center, Houston |
Responsible Party: | University of Texas Health Science Center at Houston ( Adelaide A. Hebert, MD ) |
Study ID Numbers: | R43 AR052998, HSC-MS-06-0352 |
Study First Received: | September 10, 2007 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00566904 |
Health Authority: | United States: Food and Drug Administration |
Post-herpetic Neuralgia Pain after Shingles Shingles PHN |
Neuralgia, Postherpetic Herpes Zoster Signs and Symptoms Aspirin Neuromuscular Diseases |
Neuralgia Peripheral Nervous System Diseases Lidocaine Neurologic Manifestations Pain |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors Hematologic Agents Nervous System Diseases Physiological Effects of Drugs Enzyme Inhibitors Fibrinolytic Agents Cardiovascular Agents Pharmacologic Actions |
Fibrin Modulating Agents Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Platelet Aggregation Inhibitors Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |