Human VolunteersPhase 1NCT00254449
Effect of NGX-4010 on ENFD and Sensory Function
A Phase 1 study testing NGX-4010 in people with Human Volunteers, run by NeurogesX at 1 site in United States.
Trial summary
The purpose of this study is to evaluate epidermal nerve fiber (ENF) regeneration and normalization of peripheral sensory nerve function over time in normal healthy volunteers following a 60 minute application of Capsaicin Dermal Patch (NGX 4010; capsaicin 640 mcg/cm2) as compared to comparable untreated skin areas… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Volunteers
- What is being tested?
- NGX-4010
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to May 2006
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 40 years of age.
- Male and female subjects. (Half of the subjects enrolled must be male.)
- Be in good health.
- Have intact, unscarred skin over the thighs.
- Agree not to use topically-applied products containing nonsteroidal antiinflammatory drugs, menthol, methyl salicylate, local anesthetics, steroids or capsaicin anywhere on the thighs for the duration of the study.
- Female subjects must not be breast-feeding and must have a negative serum beta human chorionic gonadotropin (hCG) pregnancy test performed within 7 days prior to the Study Patch Application Visit (Day 0).
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- All subjects must be willing to use effective methods of birth control and/or refrain from participating in a conception process during the study and for 30 days following experimental drug exposure.
- Willing and able to comply with protocol requirements for the duration of study participation. Requirements include but are not limited to attending all study visits and refraining from extensive travel during study participation.
- Subjects must sign an informed consent form for this study approved by the Investigator's Institutional Review Board (IRB).
Who cannot join
- Any dermatological condition(s) that in the judgment of the Principal Investigator has the potential to disrupt skin integrity or alter sensory function on the thighs.
- Any skin infection, skin irritation (e.g., poison oak), trauma or burn (including sunburn) on the thighs within 30 days preceding the Study Patch Application Visit (Day 0).
- Any medical history of painful conditions, surgery, or injury involving or affecting the thighs, including but not limited to prior orthopedic surgery, lumbosacral disc disease, sciatica, and hip or femur fracture.
- Any medical history of known or suspected body system abnormalities, including but not limited to diabetes, hypothyroidism, asthma or any form of peripheral or central nervous system disease.
- Use of any systemic medications that interact with the peripheral nervous system, including beta adrenergic blockers, alpha adrenergic blockers, anticonvulsant drugs, antidepressant drugs or opioids within 30 days prior to the Study Patch Application Visit (Day 0).
- Use of any topically-applied product including prescription or over the-counter (OTC) analgesic creams/lotions/patches, nonsteroidal antiinflammatory drugs, local anesthetics, steroids or capsaicin on the thighs within 30 days preceding the Study Patch Application Visit (Day 0).
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- Currently taking any prescription medication except for oral, transdermal or injected contraceptives.
- Requirement for ongoing or periodic pain medication for any chronic or recurrent medical condition.
- Participation in another drug research study within 30 days preceding the Study Patch Application Visit (Day 0).
- Diagnosis of human immunodeficiency virus (HIV) infection, according to medical history and/or self-report.
- History or current substance abuse including alcoholism/alcohol abuse, as judged by the investigator.
- Positive test result on the urine drug screen for opioids, cannabis, phencyclidine (PCP), cocaine and amphetamines performed at the Screening Visit.
- History of hypersensitivity to capsaicin (i.e., chili peppers or OTC capsaicin products), local anesthetics including lidocaine or adhesives.
Trial locations and contacts
1 site in 1 country.
United States1 site
NeurogesX Investigational Site
Minneapolis, Minnesota, 55455
About this study
Official title: A Randomized, Controlled, Open-Label Study to Investigate the Effect of NGX-4010 on Epidermal Nerve Fiber Density and Sensory Function in Healthy Volunteers
The purpose of this study is to evaluate epidermal nerve fiber (ENF) regeneration and normalization of peripheral sensory nerve function over time in normal healthy volunteers following a 60 minute application of Capsaicin Dermal Patch (NGX 4010; capsaicin 640 mcg/cm2) as compared to comparable untreated skin areas (control).The objectives of this study are: 1) To assess the difference between patch-treated and comparable untreated skin areas (control) in ENFD as quantified by PGP 9.5 immunohistochemical staining of skin biopsy samples obtained at 1, 12 and 24 weeks following a 60 minute application; 2) To assess the difference between patch-treated and comparable untreated skin areas (control) for thermal detection thresholds as assessed by QST at 1, 12 and 24 weeks following a 60 minute application; and, 3) To assess the difference between patch-treated and comparable untreated skin areas (control) in mechanical (sharp pain) sensation and tactile threshold at 1, 12 and 24 weeks following a 60 minute application.
Read the detailed description
This is a randomized, controlled, open-label, single center, phase 1 study in normal healthy volunteers. Each subject will have a 60 minute exposure to two 5.0 × 5.5 cm NGX-4010 patches. In addition, two 5.0 × 5.5 cm comparable untreated control skin areas will be identified and evaluated. At baseline and prior to skin punch biopsy at Weeks 1 (± 1 day), 12 (± 3 days) and 24 (± 7 days), QST of patch-treated and untreated control skin areas will be performed and evaluated. QST for cooling detection threshold and heat-pain threshold, and assessment of mechanical (sharp pain) sensation and tactile threshold will be performed at each of the two patch-treated and two untreated control skin areas. Serial skin punch biopsies of patch-treated and untreated control skin areas will be obtained and evaluated at Weeks 1 (± 1 day), 12 (± 3 days), and 24 (± 7 days). Skin at the patch-treated and untreated control skin areas will be anesthetized with subcutaneous 1% lidocaine, and then three millimeter (mm) skin biopsies will be obtained with a sterile punch tool from each of the designated areas. Biopsy specimens will be fixed overnight, then cryoprotected in a phosphate buffered solution until processed. Thick sections will be cut and immunostained for localization and quantification of nerve fibers in the epidermis and visualization of the subepidermal plexus using antibodies to PGP 9.5. Antibodies to type IV collagen will be used to identify the basement membrane and superficial blood vessels in the biopsy microsections. Vital signs and adverse events (AEs) will be collected at each visit. Clinical laboratory tests will be performed at the Screening Visit and at the Termination Visit (Week 24).
- Conditions
- Human Volunteers
- Being tested
- NGX-4010
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NGX-4010Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean ENFD in the patch-treated and comparable untreated skin areas (control) at 1, 12 and 24 weeks after exposure.
Mean just noticeable difference (JND) values for thermal perception QST in the patch-treated and comparable untreated skin areas (control) at 1, 12 and 24 weeks after exposure.
Mean difference in mechanical (sharp pain) sensation and tactile threshold between patch-treated and comparable untreated skin areas (control) at 1, 12 and 24 weeks after exposure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2005 (estimated)
- Study startNov 2005
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human VolunteersStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants
Sponsor and investigators
- Lead sponsor
- NeurogesX
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jeffrey Tobias, MD, Study director, NeurogesXWilliam R. Kennedy, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00254449
- Sponsor's protocol ID
- C115
- Status last verified
- Sep 2007
- First submitted
- 14 Nov 2005
- Last updated
- 16 Feb 2009
- Results posted
- No
Publications
Kennedy WR, Vanhove GF, Lu SP, Tobias J, Bley KR, Walk D, Wendelschafer-Crabb G, Simone DA, Selim MM. A randomized, controlled, open-label study of the long-term effects of NGX-4010, a high-concentration capsaicin patch, on epidermal nerve fiber density and sensory function in healthy volunteers. J Pain. 2010 Jun;11(6):579-87. doi: 10.1016/j.jpain.2009.09.019. Epub 2010 Apr 18.
PubMed 20400377
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Open-Label Study to Investigate the Effect of NGX-4010 on Epidermal Nerve Fiber Density and Sensory Function in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00254449
- Acronym / sponsor ID
- C115
- Conditions
- Human Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants
- Lead sponsor
- NeurogesXIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Study completion
- May 2006
- First posted
- 16 Nov 2005 (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.
The purpose of this study is to evaluate epidermal nerve fiber (ENF) regeneration and normalization of peripheral sensory nerve function over time in normal healthy volunteers following a 60 minute application of Capsaicin Dermal Patch (NGX 4010; capsaicin 640 mcg/cm2) as compared to comparable untreated skin areas (control).The objectives of this study are: 1) To assess the difference between patch-treated and comparable untreated skin areas (control) in ENFD as quantified by PGP 9.5 immunohistochemical staining of skin biopsy samples obtained at 1, 12 and 24 weeks following a 60 minute application; 2) To assess the difference between patch-treated and comparable untreated skin areas (control) for thermal detection thresholds as assessed by QST at 1, 12 and 24 weeks following a 60 minute application; and, 3) To assess the difference between patch-treated and comparable untreated skin areas (control) in mechanical (sharp pain) sensation and tactile threshold at 1, 12 and 24 weeks following a 60 minute application.
Detailed description
This is a randomized, controlled, open-label, single center, phase 1 study in normal healthy volunteers. Each subject will have a 60 minute exposure to two 5.0 × 5.5 cm NGX-4010 patches. In addition, two 5.0 × 5.5 cm comparable untreated control skin areas will be identified and evaluated. At baseline and prior to skin punch biopsy at Weeks 1 (± 1 day), 12 (± 3 days) and 24 (± 7 days), QST of patch-treated and untreated control skin areas will be performed and evaluated. QST for cooling detection threshold and heat-pain threshold, and assessment of mechanical (sharp pain) sensation and tactile threshold will be performed at each of the two patch-treated and two untreated control skin areas. Serial skin punch biopsies of patch-treated and untreated control skin areas will be obtained and evaluated at Weeks 1 (± 1 day), 12 (± 3 days), and 24 (± 7 days). Skin at the patch-treated and untreated control skin areas will be anesthetized with subcutaneous 1% lidocaine, and then three millimeter (mm) skin biopsies will be obtained with a sterile punch tool from each of the designated areas. Biopsy specimens will be fixed overnight, then cryoprotected in a phosphate buffered solution until processed. Thick sections will be cut and immunostained for localization and quantification of nerve fibers in the epidermis and visualization of the subepidermal plexus using antibodies to PGP 9.5. Antibodies to type IV collagen will be used to identify the basement membrane and superficial blood vessels in the biopsy microsections. Vital signs and adverse events (AEs) will be collected at each visit. Clinical laboratory tests will be performed at the Screening Visit and at the Termination Visit (Week 24).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 18 to 40 years of age.
- Male and female subjects. (Half of the subjects enrolled must be male.)
- Be in good health.
- Have intact, unscarred skin over the thighs.
- Agree not to use topically-applied products containing nonsteroidal antiinflammatory drugs, menthol, methyl salicylate, local anesthetics, steroids or capsaicin anywhere on the thighs for the duration of the study.
Key exclusion criteria (13 listed)
- Any dermatological condition(s) that in the judgment of the Principal Investigator has the potential to disrupt skin integrity or alter sensory function on the thighs.
- Any skin infection, skin irritation (e.g., poison oak), trauma or burn (including sunburn) on the thighs within 30 days preceding the Study Patch Application Visit (Day 0).
- Any medical history of painful conditions, surgery, or injury involving or affecting the thighs, including but not limited to prior orthopedic surgery, lumbosacral disc disease, sciatica, and hip or femur fracture.
- Any medical history of known or suspected body system abnormalities, including but not limited to diabetes, hypothyroidism, asthma or any form of peripheral or central nervous system disease.
- Use of any systemic medications that interact with the peripheral nervous system, including beta adrenergic blockers, alpha adrenergic blockers, anticonvulsant drugs, antidepressant drugs or opioids within 30 days prior to the Study Patch Application Visit (Day 0).
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 |
|---|---|---|
| NGX-4010 | Drug | – |
Primary outcome
Mean ENFD in the patch-treated and comparable untreated skin areas (control) at 1, 12 and 24 weeks after exposure.
Mean just noticeable difference (JND) values for thermal perception QST in the patch-treated and comparable untreated skin areas (control) at 1, 12 and 24 weeks after exposure.
Mean difference in mechanical (sharp pain) sensation and tactile threshold between patch-treated and comparable untreated skin areas (control) at 1, 12 and 24 weeks after exposure.
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 16 Feb 2009.
- Derived from this study: PubMed 20400377Kennedy WR, Vanhove GF, Lu SP, Tobias J, Bley KR, Walk D, Wendelschafer-Crabb G, Simone DA, Selim MM. A randomized, controlled, open-label study of the long-term effects of NGX-4010, a high-concentration capsaicin patch, on epidermal nerve fiber density and sensory function in healthy volunteers. J Pain. 2010 Jun;11(6):579-87. doi: 10.1016/j.jpain.2009.09.019. Epub 2010 Apr 18.
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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.
Jeffrey Tobias, MD study director
NeurogesX
William R. Kennedy, MD principal investigator
University of Minnesota
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 NGX-4010 in people with Human Volunteers, run by NeurogesX 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 9 inclusion and 13 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 16 Feb 2009. 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?
Mean ENFD in the patch-treated and comparable untreated skin areas (control) at 1, 12 and 24 weeks after exposure.. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00254449, which also lists 1 linked publication.
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 16 Feb 2009.