Effect of NGX-4010 on ENFD and Sensory Function

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.

Timeline

Start

2005-11

Primary completion

—

Completion

2006-05

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.

Drugs

Indications

No indication recorded.