Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00110760
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 Skin Filler Injection in the Face
Sponsor:
ZARS Pharma Inc
Organization:
ZARS Pharma Inc
Study Overview
Official Title:
Randomized Double-Blind Placebo Controlled Paired Study Evaluating S-Caine Peel Lidocaine 7 and Tetracaine 7 Creamfor Induction of Local Dermal Anesthesia for Dermal Filler Injection on the Face of 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:
Injection of dermal filler is used as an aesthetic treatment to fill in unwanted wrinkles and scars There can be substantial pain associated with dermal filler injections For this reason local anesthesia is often used to eliminate or minimize the pain This anesthesia can be administered by injection or through the use of topical creams and ointments
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 dermal filler injections in adults
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 dermal filler injections in adults
Detailed Description:
This study was a randomized double-blind placebo controlled paired study to evaluate the efficacy of S-Caine Peel for local dermal anesthesia for facial dermal filler injection in 70 adults The study was multi-center with 3 centers participating
Patients who presented to the study center for a dermal filler injection procedure 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 A written and dated informed consent was obtained from each patient A medical history was obtained including skin type demographic data and the use of concomitant medications A brief physical examination was performed a skin examination at the study treatment area and basic vital signs and a urine pregnancy test was obtained for females of childbearing potential
At the procedure visit patients who met the eligibility criteria were assigned the lowest available sequential patient number The randomization determined the placement of the S-Caine Peel and placebo with the active study drug applied to either the topright or bottomleft treatment area and the placebo applied to the alternate treatment area The treatment areas were defined as 2 similar anatomical locations that required similar amounts of dermal filler as measured in mLs injected and number of injections administered The point of reference for these designations was the patients right and left or top and bottom Patients had a concurrent administration of the study drugs with the appropriate study drug applied to the topright treatment area first followed immediately by the other study drug applied to the bottomleft treatment area Study drug application was double-blind The study drugs were applied with a uniform thickness of approximately 1 mm and remained on the skin for 30 minutes - 2 minutes
Upon removal of the study drugs topright treatment area removed first followed immediately by removal of the other study drug from bottomleft treatment area the investigator evaluated the treatment areas for erythema edema blanching and any adverse skin reaction
Patients who presented to the study center for a dermal filler injection procedure 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 A written and dated informed consent was obtained from each patient A medical history was obtained including skin type demographic data and the use of concomitant medications A brief physical examination was performed a skin examination at the study treatment area and basic vital signs and a urine pregnancy test was obtained for females of childbearing potential
At the procedure visit patients who met the eligibility criteria were assigned the lowest available sequential patient number The randomization determined the placement of the S-Caine Peel and placebo with the active study drug applied to either the topright or bottomleft treatment area and the placebo applied to the alternate treatment area The treatment areas were defined as 2 similar anatomical locations that required similar amounts of dermal filler as measured in mLs injected and number of injections administered The point of reference for these designations was the patients right and left or top and bottom Patients had a concurrent administration of the study drugs with the appropriate study drug applied to the topright treatment area first followed immediately by the other study drug applied to the bottomleft treatment area Study drug application was double-blind The study drugs were applied with a uniform thickness of approximately 1 mm and remained on the skin for 30 minutes - 2 minutes
Upon removal of the study drugs topright treatment area removed first followed immediately by removal of the other study drug from bottomleft treatment area the investigator evaluated the treatment areas for erythema edema blanching and any 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