S-Caine™ Peel (Skin Numbing Cream) to Treat Pain During Laser-Assisted Tattoo Removal in Adults - Full Text View

Sponsored by:	ZARS Pharma Inc.
Information provided by:	ZARS Pharma Inc.
ClinicalTrials.gov Identifier:	NCT00110734

Purpose

There is pain associated with laser-assisted tattoo removal. For this reason, some form of anesthesia is commonly used to eliminate or minimize the pain. This anesthesia is usually a topical local anesthetic cream or ointment spread over the skin. The purpose of this study is to further estimate the effectiveness of S-Caine™ Peel (lidocaine 7% and tetracaine 7% cream) for treating pain during laser-assisted tattoo removal.

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, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo Controlled, Paired Study Evaluating S-Caine™ Peel (Lidocaine 7% and Tetracaine 7% Cream) for Induction of Local Dermal Anesthesia for Laser-Assisted Tattoo Removal in Adults

Further study details as provided by ZARS Pharma Inc.:

Primary Outcome Measures:

To evaluate the efficacy of S-Caine Peel when applied for 60 minutes for induction of local dermal anesthesia prior to laser-assisted tattoo removal in adults

Secondary Outcome Measures:

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

Estimated Enrollment:	60
Estimated Study Completion Date:	September 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient is 18 years of age or older
Patient elects to undergo laser-assisted tattoo removal

Exclusion Criteria:

Patient is pregnant or breastfeeding
Patient has participated in a clinical trial of an unapproved drug within the previous 30 days
Patient has participated in any previous clinical trial involving S-Caine Peel

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110734

Locations

United States, New York
Laser and Skin Surgery Center of New York
New York, New York, United States, 10016

Sponsors and Collaborators

ZARS Pharma Inc.

More Information

Study ID Numbers:	SCP-43-05
Study First Received:	May 12, 2005
Last Updated:	September 21, 2005
ClinicalTrials.gov Identifier:	NCT00110734
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