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Sponsored by: |
NeurogesX |
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Information provided by: | NeurogesX |
ClinicalTrials.gov Identifier: | NCT00528216 |
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.
Condition | Intervention | Phase |
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Pain |
Drug: Capsaicin Dermal Liquid |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Placebo Control, 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 |
Estimated Enrollment: | 20 |
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.
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | C201 |
Study First Received: | September 10, 2007 |
Last Updated: | March 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00528216 |
Health Authority: | United States: Food and Drug Administration |
Analgesics Capsaicin |
Pain Healthy Capsaicin |
Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Antipruritics |
Peripheral Nervous System Agents Dermatologic Agents Pharmacologic Actions |