NCT00528216

Study of Three Capsaicin Dermal Liquid Formulations on Epidermal Nerve Fiber Immunostaining and Sensory Function

A Randomized, Controlled, Single-Blind Study to Investigate the Effect of Three Capsaicin Dermal Liquid Formulations on Epidermal Nerve Fiber Immunostaining and Sensory Function In Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: NeurogesX · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate potential changes in epidermal nerve fiber immunostaining (ENFI) and sensory nerve function in healthy normal volunteers following single applications of three different investigational topical Capsaicin Dermal Liquids (10% w/v trans capsaicin), and a comparable control (propylene glycol). In addition, the pain and tolerability of the application of each formulation will also be assessed. Data from this clinical study may be used to select a formulation for further clinical evaluation.

Detailed description

This is a randomized, controlled, single-blind, single-center, Phase 1 study in twenty normal healthy volunteers. Each subject will have a single 15 minute exposure to each of three topical Capsaicin Dermal Liquids and the control. Each application site, located on the distal and proximal anterior medial thigh areas, will be 5.0 × 5.0 cm in size. The volume applied will be 15 mcL per cm2 and hence the total volume applied will be 375 mcL. At baseline and prior to skin punch biopsy at Day 7, QST of the four application sites for warming and cooling detection thresholds, and assessment of mechanical (sharp pain) sensation and tactile thresholds, will be performed and evaluated. This will be repeated at each of the four application sites on Day 7 and the Termination Visit.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Capsaicin Dermal Liquid

Timeline

• First posted: 2007-09-12
• Last updated: 2008-03-06