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Effect of NGX-4010 on ENFD and Sensory Function

NCT00254449 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2009-02-16

No results posted yet for this study

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

Interventions

DRUG

NGX-4010

Sponsors & Collaborators

  • NeurogesX

    lead INDUSTRY

Principal Investigators

  • Jeffrey Tobias, MD · NeurogesX

  • William R. Kennedy, MD · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-11-30
Completion
2006-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00254449 on ClinicalTrials.gov