New Topical Treatment for Continued Pain After Shingles

Sponsor

Biomedical Development Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT00566904

Collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIH), The University of Texas Health Science Center, Houston (Other)

Enrollment

Location

Arm

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Postherpetic Neuralgia	Drug: Epikeia coatings with aspirin Drug: Epikeia coatings with lidocaine Other: Epikeia coatings alone	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

Phase 1 Novel Topical Treatment for Post-herpetic Neuralgia

Study Start Date :

Sep 1, 2006

Actual Primary Completion Date :

Aug 1, 2008

Actual Study Completion Date :

Sep 1, 2008

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Latency to analgesia onset and duration of analgesia measures [Between 8 and 16 hours after treatment application]

Secondary Outcome Measures

Skin irritation potential [Between 8 and 24 hours after treatment application]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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