S-Caine™ Peel (Skin Numbing Cream) to Treat Pain During Pulsed Dye Laser (PDL) Therapy in Adults - Full Text View

Sponsored by:	ZARS Pharma Inc.
Information provided by:	ZARS Pharma Inc.
ClinicalTrials.gov Identifier:	NCT00110773

Purpose

Pulsed dye laser (PDL) on the face is painful. For this reason, local anesthesia is commonly used to eliminate or minimize the pain. S-Caine™ Peel (lidocaine 7% and tetracaine 7% cream) is a eutectic formulation of lidocaine and tetracaine. The purpose of this study is to evaluate the efficacy of S-Caine Peel for induction of local dermal anesthesia for PDL therapy in adults.

Condition	Intervention	Phase
Pain	Drug: S-Caine™ Peel (lidocaine and tetracaine topical 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, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo Controlled, Parallel Study Evaluating the Efficacy of S-Caine™ Peel (Lidocaine 7% and Tetracaine 7% Cream) to Provide Local Dermal Anesthesia for Pulsed Dye Laser Therapy 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 20 minutes, for induction of local dermal anesthesia before PDL therapy 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:

80

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 PDL therapy for the treatment of vascular lesions on the face

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 clinical trial involving S-Caine Peel

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110773

Locations

United States, District of Columbia
Washington Institute of Dermatologic Laser Surgery
Washington, District of Columbia, United States, 20037
United States, Michigan
Midwest Cutaneous Research
Clinton Township, Michigan, United States, 48038
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-42-05
Study First Received:	May 12, 2005
Last Updated:	September 30, 2005
ClinicalTrials.gov Identifier:	NCT00110773
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