Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00107835
Status:
COMPLETED
Last Update Posted:
2012-06-06
First Post:
2005-04-08
Brief Title:
Safety Study of S-Caine Peel Skin Numbing Cream Before a Painful Dermatologic Procedure in Adults
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 Adult Patients Undergoing a Minor or Major Dermal Procedure
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
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 adults 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 purpose of this study is to gain additional safety information for S-Caine Peel when used in minor and major dermal procedures in adults
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 purpose of this study is to gain additional safety information for S-Caine Peel when used in minor and major dermal procedures in adults
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