Study of Three Capsaicin Dermal Liquid Formulations on Epidermal Nerve Fiber Immunostaining and Sensory Function
|ClinicalTrials.gov Identifier: NCT00528216|
Recruitment Status : Completed
First Posted : September 12, 2007
Last Update Posted : March 6, 2008
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: Capsaicin Dermal Liquid||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|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|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00528216
|Study Director:||Jeff Tobias, MD||NeurogesX|