Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00254449
Status:
COMPLETED
Last Update Posted:
2009-02-16
First Post:
2005-11-14
Brief Title:
Effect of NGX-4010 on ENFD and Sensory Function
Sponsor:
NeurogesX
Organization:
NeurogesX
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mcgcm2 as compared to comparable untreated skin areas controlThe 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 95 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 50 55 cm NGX-4010 patches In addition two 50 55 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 95 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None