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

Sponsored by:	ZARS Pharma Inc.
Information provided by:	ZARS Pharma Inc.
ClinicalTrials.gov Identifier:	NCT00110253

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 III

MedlinePlus related topics: Anesthesia

Drug Information available for: Tetracaine Viractin Lidocaine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by ZARS Pharma Inc.:

Primary Outcome Measures:

To evaluate the duration of anesthetic effect produced by S-Caine Peel when applied for 30 and 60 minutes

Secondary Outcome Measures:

To monitor the nature and frequency of adverse events (AEs) associated with the application of S-Caine Peel

Estimated Enrollment:	40
Study Start Date:	June 2005

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

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

Study ID Numbers:	SCP-44-05
Study First Received:	May 4, 2005
Last Updated:	September 21, 2005
ClinicalTrials.gov Identifier:	NCT00110253
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Tetracaine
Lidocaine
Pain

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Cardiovascular Agents

Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions
Anesthetics, Local

ClinicalTrials.gov processed this record on January 16, 2009