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Duration of Skin Numbing Effect Created by the S-Caine™ Peel

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ZARS Pharma Inc.
ClinicalTrials.gov Identifier:
NCT00110253
First received: May 4, 2005
Last updated: June 4, 2012
Last verified: June 2012

May 4, 2005
June 4, 2012
June 2005
June 2005   (final data collection date for primary outcome measure)
Duration of anesthetic effect [ Time Frame: first time after onset when the number of painful pinpricks was 3 or more for 2 consecutive time points ] [ Designated as safety issue: No ]
The duration of anesthesia was defined as the difference between the onset and end of anesthesia. If there was no onset of anesthesia, the duration was defined as zero. Onset of anesthesia was defined as the first time that the number of painful pinpricks was 2 or less (out of 5) for 2 consecutive time points. For subjects/treatments with onset of anesthesia, the end of anesthesia was defined as the first time after onset when the number of painful pinpricks was 3 or more for 2 consecutive time points
To evaluate the duration of anesthetic effect produced by S-Caine Peel when applied for 30 and 60 minutes
Complete list of historical versions of study NCT00110253 on ClinicalTrials.gov Archive Site
Number of participants with adverse events [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
To monitor the nature and frequency of adverse events (AEs) associated with the application of S-Caine Peel
To monitor the nature and frequency of adverse events (AEs) associated with the application of S-Caine Peel
Not Provided
Not Provided
 
Duration of Skin Numbing Effect Created by the S-Caine™ Peel
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

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.

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 1:1 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 1:1 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

Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pain
Drug: S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%)
S-Caine Peel is composed of a 1:1 eutectic mixture of 7% lidocaine, and 7% tetracaine, which was applied topically. The S Caine Peel was applied at approximately 1 mm in thickness and remained on the treatment area for 30 or 60 minutes
Other Name: Pliaglis
Experimental: S-Caine Peel
Intervention: Drug: S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
June 2005
June 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject is 18 years of age or older.
  • Meet pinprick test requirements.

Exclusion Criteria:

  • Subject is pregnant or breastfeeding.
  • Subject has participated in a clinical trial of an unapproved drug within the previous 30 days.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00110253
SCP-44-05
No
ZARS Pharma Inc.
ZARS Pharma Inc.
Not Provided
Principal Investigator: William Garland, MD Radiant Research San Diego
ZARS Pharma Inc.
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP