Postherpetic NeuralgiaPhase 1NCT00566904
New Topical Treatment for Continued Pain After Shingles
A Phase 1 study testing Epikeia coatings with aspirin, Epikeia coatings with lidocaine and Epikeia coatings alone in people with Postherpetic Neuralgia, run by Biomedical Development Corporation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postherpetic Neuralgia
- What is being tested?
- Epikeia coatings with aspirin, Epikeia coatings with lidocaine and Epikeia coatings alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Sep 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Dermatology Clincial Reseach Center
Houston, Texas, 77030
About this study
Official title: 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.
Read the 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.
- Conditions
- Postherpetic Neuralgia
- Being tested
- Epikeia coatings with aspirin, Epikeia coatings with lidocaine, Epikeia coatings alone
- Keywords
- Post-herpetic Neuralgia, Pain after Shingles, Shingles, PHN
- Medical subject headings
- Neuralgia, Postherpetic, Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epikeia coatings with aspirinDrug
Also called Epikeia coatings with acetylsalicylic acid
Applied to affected skin area using a roll-on ball applicator
Epikeia coatings with lidocaineDrug
Also called Epikeia coatings with local anesthetic
Applied to affected skin area using a roll-on ball applicator
Epikeia coatings aloneOther
Applied to affected skin area using a roll-on ball applicator
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive one of three different topical treatments on Days 8, 15, or 22. Receives: Drug: Epikeia coatings with aspirin; Drug: Epikeia coatings with lidocaine; Other: Epikeia coatings alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Latency to analgesia onset and duration of analgesia measures
Measured: Between 8 and 16 hours after treatment application
Secondary outcomes (1)
Skin irritation potential
Measured: Between 8 and 24 hours after treatment application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2007 (estimated)
- Study startSep 2006
- Primary completionAug 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postherpetic NeuralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomedical Development Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), The University of Texas Health Science Center, Houston
- Responsible party
- Sponsor
- Investigators
- Adelaide A. Hebert, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00566904
- Sponsor's protocol ID
- R43AR052998
- Other IDs
- 1R43AR052998-01, HSC-MS-06-0352
- Status last verified
- Aug 2011
- First submitted
- 10 Sep 2007
- Last updated
- 31 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Novel Topical Treatment for Post-herpetic Neuralgia
- ClinicalTrials.gov ID
- NCT00566904
- Acronym / sponsor ID
- R43AR052998
- Conditions
- Postherpetic Neuralgia
- Keywords
- Post-herpetic Neuralgia, Pain after Shingles, Shingles, PHN
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Biomedical Development CorporationIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), The University of Texas Health Science Center, Houston
- Study start
- Sep 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 4 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Epikeia coatings with aspirin, Drug: Epikeia coatings with lidocaine, Other: Epikeia coatings aloneParticipants will receive one of three different topical treatments on Days 8, 15, or 22. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epikeia coatings with aspirinAlso: Epikeia coatings with acetylsalicylic acidApplied to affected skin area using a roll-on ball applicator | Drug | 1 |
| Epikeia coatings with lidocaineAlso: Epikeia coatings with local anestheticApplied to affected skin area using a roll-on ball applicator | Drug | 1 |
| Epikeia coatings aloneApplied to affected skin area using a roll-on ball applicator | Other | 1 |
Primary outcome
Latency to analgesia onset and duration of analgesia measures
Time frame: Between 8 and 16 hours after treatment application
1 secondary outcome
Skin irritation potential
Time frame: Between 8 and 24 hours after treatment application
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2011.
Related trials for Postherpetic Neuralgia
Not yet recruitingPhase 1
Simultaneous Engagement of Networks for Alleviating Pain (SENAP)
Neuropathic Pain, Postherpetic Neuralgia
Active, not recruiting
Transcranial Magnetic Stimulation for Chronic Neuropathic Pain
Chronic Neuropathic Pain, Post-Stroke Pain
Active, not recruitingObservational study
Obesity and Obesity-Related Factors and Risk of Herpes Zoster (Shingles) and Postherpetic Neuralgia
Herpes Zoster (HZ)
Recruiting
The Analgesic Efficacy and Safety of Venlafaxine for Prevention of Postherpetic Neuralgia in Patients With Acute Herpes Zoster
Herpes Zoster, Pain
RecruitingPhase 2
A Clinical Trial to Evaluate the Efficacy and Safety of HL-1186 Tablet in the Treatment of Postherpetic Neuralgia
Postherpetic Neuralgia ( PHN )
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adelaide A. Hebert, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Epikeia coatings with aspirin, Epikeia coatings with lidocaine and Epikeia coatings alone in people with Postherpetic Neuralgia, run by Biomedical Development Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Latency to analgesia onset and duration of analgesia measures (time frame: Between 8 and 16 hours after treatment application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2011; AzTrials last refreshed its copy on 6 Nov 2026.