NCT00758433

Civamide Patch Safety, Tolerability and PK Study

Randomized, Double-Blind, Placebo-Controlled Evaluation of the Tolerability of Two Civamide (Zucapsaicin) Patch Strengths Compared to Placebo Patch in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Winston Laboratories · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

To evaluate the tolerability of two different strengths of a Civamide Patch (0.0075% and 0.0150%) compared to the placebo patch and each other in healthy adult volunteers. To assess the pharmacokinetics of civamide and to determine if there is systemic absorption of the drug from civamide patch in a subset of study subjects.

Detailed description

This is a double-blind, randomized study of the tolerability of two different strengths of a Civamide Patch compared to placebo patch. The study consists of a Screening Period (Days -21 to Day 1), a one week Treatment Period (Days 1-8) and a follow-up telephone call to subjects on Day 10. Pharmacokinetics will be assessed relative to dosing on Day 1, Day 2, and Day 8 in a subset of subjects. Subjects will also rate stinging and burning sensation at the application site during the Treatment Period. Twenty-four (24) hours after the last patch application, subjects will return to the study site on Day 8. The treatment area will be evaluated by the Study Physician. Subjects will complete a Subject's Global Rating of Stinging and Burning Sensation and a Subject's Global Rating of Tolerability.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Zucapsaicin	Civamide patch 0.0075% q.d. 24 hours for 7 days
DRUG	Zucapsaicin	Civamide patch 0.0150% q.d. 24 hours for 7 days
DRUG	Placebo patch	Placebo patch q.d. 24 hours for 7 days

Timeline

• Start date: 2008-09-01
• Primary completion: 2008-12-01
• Completion: 2009-04-01
• First posted: 2008-09-25
• Last updated: 2011-06-10

Locations

1 site across 1 country: United States