New Topical Treatment for Continued Pain After Shingles

August 29, 2011 updated by: Biomedical Development Corporation

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Latency to analgesia onset and duration of analgesia measures
Time Frame: Between 8 and 16 hours after treatment application
Between 8 and 16 hours after treatment application

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Skin irritation potential
Time Frame: Between 8 and 24 hours after treatment application
Between 8 and 24 hours after treatment application

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biomedical Development Corporation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The University of Texas Health Science Center, Houston
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Adelaide A. Hebert, MD, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 10, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R43AR052998 (U.S. NIH Grant/Contract)
  • 1R43AR052998-01 (U.S. NIH Grant/Contract)
  • HSC-MS-06-0352

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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