Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00107822
Status:
COMPLETED
Last Update Posted:
2005-10-06
First Post:
2005-04-08
Brief Title:
Safety Study of S-Caine Peel Skin Numbing Cream Before a Painful Dermatologic Procedure in Children
Sponsor:
ZARS Pharma Inc
Organization:
ZARS Pharma Inc
Study Overview
Official Title:
An Open-Label Safety Study to Evaluate the Use of S-Caine Peel Lidocaine 7 and Tetracaine 7 Cream in Pediatric Patients Undergoing a Minor or Major Dermal Procedure
Status:
COMPLETED
Status Verified Date:
2005-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety of one treatment of S-Caine Peel skin numbing cream applied on healthy skin before a painful dermatologic procedure in children This study will also evaluate how well the S-Caine Peel eases the pain of the procedure
Detailed Description:
The practice of dermatology is seeing a rise in the number of surgical and laser procedures as technological advances have expanded the number of conditions amenable to these evolving therapies Skin biopsies shave excisions deep excisions electro-surgical procedures intralesional injections and laser surgery are frequently performed by dermatologists on a daily basis Some pain accompanies almost all of these procedures and a local anesthetic is commonly used Traditionally intracutaneous injection of lidocaine with or without epinephrine has been the anesthetic of choice However patients undergoing these procedures are often afraid of needles and syringes and the pain associated with injections As a result topical anesthetic agents have been explored and developed as painless alternatives to injected anesthesia
S-Caine Peel lidocaine 7 and tetracaine 7 cream consists of a new eutectic formulation of lidocaine and tetracaine S-Caine Peel is a topical local anesthetic cream that forms a pliable peel on the skin when exposed to air S-Caine Peel is not occluded during application
The pain associated with medical procedures is often under-treated in children Children often undergo painful procedures with little or no anesthetic even when effective therapy is available Reasons for not providing available therapy in children include concerns over adverse side effects as well as the length of time necessary to provide adequate anesthesia Recent guidelines strongly advocate for the proactive treatment of pain in children including the pain associated with medical procedures
S-Caine Peel lidocaine 7 and tetracaine 7 cream consists of a new eutectic formulation of lidocaine and tetracaine S-Caine Peel is a topical local anesthetic cream that forms a pliable peel on the skin when exposed to air S-Caine Peel is not occluded during application
The pain associated with medical procedures is often under-treated in children Children often undergo painful procedures with little or no anesthetic even when effective therapy is available Reasons for not providing available therapy in children include concerns over adverse side effects as well as the length of time necessary to provide adequate anesthesia Recent guidelines strongly advocate for the proactive treatment of pain in children including the pain associated with medical procedures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None