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

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

This study has been completed.

Study NCT00110773. Last updated on September 30, 2005. Information provided by ZARS Pharma Inc.

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	S-Caine™ Peel (Skin Numbing Cream) to Treat Pain During Pulsed Dye Laser (PDL) Therapy in Adults
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
Brief Summary	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.
Detailed Description
Study Phase	Phase III
Study Type ^†	Interventional
Study Design ^†	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure ^†	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 Measure ^†	To monitor the nature and frequency of adverse events (AEs) associated with the application of S-Caine Peel
Condition ^†	Pain
Intervention ^†	Drug: S-Caine™ Peel (lidocaine and tetracaine topical cream 7%/7%)
MEDLINE PMIDs
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Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†	80
Start Date ^†
Completion Date
Eligibility 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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00110773
Organization ID	SCP-42-05
Secondary IDs ^††
Study Sponsor ^†	ZARS Pharma Inc.
Collaborators ^††
Investigators ^†
Information Provided By	ZARS Pharma Inc.
Verification Date	September 2005
First Received Date ^†	May 12, 2005
Last Updated Date	September 30, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.