Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-31 @ 4:44 PM
Study NCT ID:
NCT00758433
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2008-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Civamide Patch Safety, Tolerability and PK Study
Sponsor:
Winston Laboratories
Organization:
Study Overview
Official Title:
Randomized, Double-Blind, Placebo-Controlled Evaluation of the Tolerability of Two Civamide (Zucapsaicin) Patch Strengths Compared to Placebo Patch in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: