Effect of NGX-4010 on ENFD and Sensory Function

NCT00254449 | Completed Phase 1

• 1 other identifier: C115
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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 (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.

Conditions

Human Volunteers

Outcome Measures

Primary Outcomes (3)

• 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.

Interventions

NGX-4010 DRUG

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).
• 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).

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• NeurogesX: lead

Study Sites (1)

NeurogesX Investigational Site

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

• 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.

  PMID: 20400377 DERIVED

MeSH Terms

Interventions

Capsaicin

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Officials

• Jeffrey Tobias, MD

  NeurogesX

  STUDY DIRECTOR

• William R. Kennedy, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 14, 2005
• First Posted: November 16, 2005
• Study Start: November 1, 2005
• Study Completion: May 1, 2006
• Last Updated: February 16, 2009

Record last verified: 2007-09

Locations

US (1)