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
  Purpose

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.


Condition Intervention Phase
Pain
Drug: S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by ZARS Pharma Inc.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 40
Study Start Date: June 2005
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: S-Caine Peel 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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110253

Locations
United States, California
Radiant Research
San Diego, California, United States, 92123
Sponsors and Collaborators
ZARS Pharma Inc.
Investigators
Principal Investigator: William Garland, MD Radiant Research San Diego
  More Information

No publications provided

Responsible Party: ZARS Pharma Inc.
ClinicalTrials.gov Identifier: NCT00110253     History of Changes
Other Study ID Numbers: SCP-44-05
Study First Received: May 4, 2005
Last Updated: June 4, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lidocaine
Tetracaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014