S-Caine™ Peel (Skin Numbing Cream) to Treat Pain During Skin Filler Injection in the Face - Full Text View

Sponsored by:	ZARS Pharma Inc.
Information provided by:	ZARS Pharma Inc.
ClinicalTrials.gov Identifier:	NCT00110760

Purpose

Injection of dermal filler is used as an aesthetic treatment to fill in unwanted wrinkles and scars. There can be substantial pain associated with dermal filler injections. For this reason, local anesthesia is often used to eliminate or minimize the pain. This anesthesia can be administered by injection or through the use of topical creams and ointments.

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 if S-Caine Peel is effective in providing topical local dermal anesthesia for dermal filler injections in adults.

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), When Applied for 30 Minutes, for Induction of Local Dermal Anesthesia for Dermal Filler Injection on the Face of Adults

Further study details as provided by ZARS Pharma Inc.:

Primary Outcome Measures:

To evaluate the efficacy of S-Caine Peel for induction of local dermal anesthesia for dermal filler injection in adults

Secondary Outcome Measures:

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

Estimated Enrollment:

70

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 dermal filler injection in 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 previous clinical trial involving S-Caine Peel

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110760

Locations

United States, Colorado
AboutSkin Dermatology
Englewood, Colorado, United States, 80113
United States, Tennessee
Tennessee Clinical Research Center
Nashville, Tennessee, United States, 37215
United States, Texas
J&S Studies, Inc.
Bryan, Texas, United States, 77802

Sponsors and Collaborators

ZARS Pharma Inc.

More Information

Study ID Numbers:	SCP-40-05
Study First Received:	May 12, 2005
Last Updated:	September 21, 2005
ClinicalTrials.gov Identifier:	NCT00110760
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Tetracaine
Facies
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