Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00110773
Status:
COMPLETED
Last Update Posted:
2012-06-05
First Post:
2005-05-12
Brief Title:
S-Caine Peel Skin Numbing Cream to Treat Pain During Pulsed Dye Laser PDL Therapy in Adults
Sponsor:
ZARS Pharma Inc
Organization:
ZARS Pharma Inc
Study Overview
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
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:
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:
This was a multi-center 5 centers double-blind placebo-controlled parallel study that included 80 adults who met all the eligibility criteria and who were undergoing PDL therapy for the treatment of vascular lesions on the face
During the screening visit the study including potential risks and benefits was clearly explained to each patient and written informed consent was obtained from each patient The screening visit also included evaluating eligibility criteria obtaining a medical history including skin type demographic data and concomitant medications a brief physical examination and a urine pregnancy test for women of childbearing potential The screening visit could be completed on the same day as the procedure visit
At the procedure visit eligible patients were assigned the next available sequential patient number By having a patient number assigned to them patients were randomized to receive S-Caine Peel or placebo on the facial treatment area
The surface area of the intended treatment area was determined up to 200 cm2 A thin layer approximately 1 mm or the thickness of a dime of the study drug was applied evenly across the area to be treated The study drug was applied for 20 minutes 2 minutes
Immediately following removal of the study drug the investigator performed an evaluation of skin reactions assessing the treatment area for erythema edema and blanching or any other adverse skin reaction
During the screening visit the study including potential risks and benefits was clearly explained to each patient and written informed consent was obtained from each patient The screening visit also included evaluating eligibility criteria obtaining a medical history including skin type demographic data and concomitant medications a brief physical examination and a urine pregnancy test for women of childbearing potential The screening visit could be completed on the same day as the procedure visit
At the procedure visit eligible patients were assigned the next available sequential patient number By having a patient number assigned to them patients were randomized to receive S-Caine Peel or placebo on the facial treatment area
The surface area of the intended treatment area was determined up to 200 cm2 A thin layer approximately 1 mm or the thickness of a dime of the study drug was applied evenly across the area to be treated The study drug was applied for 20 minutes 2 minutes
Immediately following removal of the study drug the investigator performed an evaluation of skin reactions assessing the treatment area for erythema edema and blanching or any other adverse skin reaction
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