Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00110253
Status:
COMPLETED
Last Update Posted:
2012-06-05
First Post:
2005-05-04
Brief Title:
Duration of Skin Numbing Effect Created by the S-Caine Peel
Sponsor:
ZARS Pharma Inc
Organization:
ZARS Pharma Inc
Study Overview
Official Title:
A Randomized Double-Blind Paired Placebo Controlled Study Evaluating the Duration of Anesthetic Effect Produced by the S-Caine Peel Lidocaine 7 and Tetracaine 7 Cream When Applied for 30 and 60 Minutes
Status:
COMPLETED
Status Verified Date:
2012-06
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:
S-Caine Peel lidocaine 7 and tetracaine 7 cream is a new skin numbing cream made of lidocaine and tetracaine The purpose of this study is to evaluate and measure the length of time the S-Caine Peel numbs the skin when applied for 30 and 60 minutes
Detailed Description:
This was a single center randomized double-blind placebo controlled paired study that evaluated the duration of anesthetic effect produced by S-Caine Peel when applied for 30 or 60 minutes in 40 adult volunteers A pinprick test was used to determine duration of anesthetic effect
At the procedure visit subjects were to be assigned the lowest available sequential subject number Treatment was randomized according to a computer-generated randomization schedule provided by the sponsor The randomization to application time of 30 or 60 minutes was to be 11 and un-blinded The randomization of study drug to treatment area concurrent applications of either S Caine Peel applied to the anterior surface of the right thigh with placebo applied to the anterior surface of the left thigh or placebo applied to the anterior surface of the right thigh and S-Caine Peel applied to the anterior surface of the left thigh was 11 and double-blind Instructions for implementing the randomization ie the correct application time and treatment area appeared on the study drug labels assigned to each subject number
Subjects were administered both S-Caine Peel and placebo on separate thighs for either 30 or 60 minutes The study drugs were applied concurrently to the anterior surfaces of the right and left thigh one application per thigh with study drug applied to the right thigh first followed immediately by application of the alternate study drug to the left thigh Each study drug was dispensed to cover a 200 cm² treatment area with a uniform thickness of approximately 1 mm
At the procedure visit subjects were to be assigned the lowest available sequential subject number Treatment was randomized according to a computer-generated randomization schedule provided by the sponsor The randomization to application time of 30 or 60 minutes was to be 11 and un-blinded The randomization of study drug to treatment area concurrent applications of either S Caine Peel applied to the anterior surface of the right thigh with placebo applied to the anterior surface of the left thigh or placebo applied to the anterior surface of the right thigh and S-Caine Peel applied to the anterior surface of the left thigh was 11 and double-blind Instructions for implementing the randomization ie the correct application time and treatment area appeared on the study drug labels assigned to each subject number
Subjects were administered both S-Caine Peel and placebo on separate thighs for either 30 or 60 minutes The study drugs were applied concurrently to the anterior surfaces of the right and left thigh one application per thigh with study drug applied to the right thigh first followed immediately by application of the alternate study drug to the left thigh Each study drug was dispensed to cover a 200 cm² treatment area with a uniform thickness of approximately 1 mm
Study Oversight
Has Oversight DMC:
None
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?:
None