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

NCT ID: NCT00110253

Last Updated: 2012-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2005-06-30

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 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

Conditions

Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

S-Caine Peel

Group Type: EXPERIMENTAL

S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%)

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Pliaglis

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ZARS Pharma Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Garland, MD

Role: PRINCIPAL_INVESTIGATOR

Radiant Research San Diego

Locations

Radiant Research

San Diego, California, United States

Countries

United States

Other Identifiers

SCP-44-05

Identifier Type: -

Identifier Source: org_study_id