Study of Three Capsaicin Dermal Liquid Formulations on Epidermal Nerve Fiber Immunostaining and Sensory Function
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Official Title:||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|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00528216
|Study Director:||Jeff Tobias, MD||NeurogesX|