Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00110747
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 Non-Ablative Facial Laser Resurfacing in Adults
Sponsor:
ZARS Pharma Inc
Organization:
ZARS Pharma Inc
Study Overview
Official Title:
A Randomized Double-Blind Placebo Controlled Paired Study Evaluating the Efficacy of S-Caine Peel Lidocaine 7 and Tetracaine 7 Cream in Providing Local Dermal Anesthesia for Non-Ablative Facial Laser Resurfacing 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:
Lasers are used for non-ablative resurfacing of facial rhytides atrophic scars and a variety of epidermal and dermal lesions Pain associated with the non-ablative laser treatment has been described as moderate to severe 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 if S-Caine Peel is effective in providing topical local dermal anesthesia for non-ablative facial laser resurfacing in adults
Detailed Description:
This was a multicenter randomized double-blind placebo-controlled paired study that evaluated the effectiveness of S-Caine Peel in providing local dermal anesthesia for non-ablative facial laser resurfacing Patients received a concurrent application of S Caine Peel and placebo for 30 minutes 2 minutes
Patients who presented to the study site for a non-ablative facial laser resurfacing and who met study entry criteria were invited to participate in the study At the screening visit the study including potential risks and benefits was clearly explained to each patient and written informed consent was obtained A medical history was obtained including skin type demographic data prior and current medical disorders and the use of concomitant medications A brief physical examination was performed including taking basic vital signs and examining the skin at the study drug application site If applicable a urine pregnancy test was performed The screening visit could occur on the same day as the procedure visit
At the procedure visit patients were randomized to receive a 30-minute 2 minute application of S Caine Peel either on the right or left treatment area and to receive a concurrent 30-minute 2 minutes application of placebo on the alternate treatment area The point of reference was always the patients right and left S-Caine Peel and placebo were dispensed to cover the treatment area with a uniform thickness of approximately 1 mm Study drug was applied to the right treatment area first then concurrently to the left treatment area Similarly the study drug was removed first from the right treatment area and then from the left treatment area Following removal of the study drugs the investigator or physician subinvestigator evaluated each study drug application site for erythema edema blanching or other skin reactions The right treatment area was evaluated first followed by the left treatment area
After the skin evaluations the laser procedure was performed on the right treatment area followed by patient and investigator efficacy evaluations for the right treatment area The laser procedure was then performed on the left treatment area followed by patient and investigator efficacy evaluations for the left treatment area
Patients who presented to the study site for a non-ablative facial laser resurfacing and who met study entry criteria were invited to participate in the study At the screening visit the study including potential risks and benefits was clearly explained to each patient and written informed consent was obtained A medical history was obtained including skin type demographic data prior and current medical disorders and the use of concomitant medications A brief physical examination was performed including taking basic vital signs and examining the skin at the study drug application site If applicable a urine pregnancy test was performed The screening visit could occur on the same day as the procedure visit
At the procedure visit patients were randomized to receive a 30-minute 2 minute application of S Caine Peel either on the right or left treatment area and to receive a concurrent 30-minute 2 minutes application of placebo on the alternate treatment area The point of reference was always the patients right and left S-Caine Peel and placebo were dispensed to cover the treatment area with a uniform thickness of approximately 1 mm Study drug was applied to the right treatment area first then concurrently to the left treatment area Similarly the study drug was removed first from the right treatment area and then from the left treatment area Following removal of the study drugs the investigator or physician subinvestigator evaluated each study drug application site for erythema edema blanching or other skin reactions The right treatment area was evaluated first followed by the left treatment area
After the skin evaluations the laser procedure was performed on the right treatment area followed by patient and investigator efficacy evaluations for the right treatment area The laser procedure was then performed on the left treatment area followed by patient and investigator efficacy evaluations for the left treatment area
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