S-Caine™ Peel (Skin Numbing Cream) to Treat Pain During Skin Filler Injection in the Face
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.
|Pain||Drug: S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%) Drug: Placebo Peel||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Randomized, Double-Blind, Placebo Controlled, Paired Study Evaluating S-Caine™ Peel (Lidocaine 7% and Tetracaine 7% Cream)for Induction of Local Dermal Anesthesia for Dermal Filler Injection on the Face of Adults|
- Pain Intensity [ Time Frame: 30 minutes ]Patient's evaluation of procedural pain intensity using the VAS. Immediately after completion of the dermal filler injections in each treatment area, patients completed a 100 mm horizontal VAS where 0 mm = no pain and 100 mm = the worst pain you can imagine
- Number of participants with adverse events [ Time Frame: 30 minutes ]To monitor the nature and frequency of adverse events (AEs) associated with the use of S-Caine Peel
- Patient's evaluation of the adequacy of pain relief [ Time Frame: 30 minutes ]After the dermal filler procedure, each patient was asked to evaluate the efficacy of each study drug by answering the following questions: (i) Did this study drug provide adequate pain relief for the procedure (yes/no)? ; (ii) Would you have topical anesthesia administered using this study drug again if given the option (yes/no)?
|Study Start Date:||June 2005|
|Study Completion Date:||September 2005|
|Primary Completion Date:||September 2005 (Final data collection date for primary outcome measure)|
|Experimental: S-Caine Peel||
Drug: S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%)
S-Caine Peel was composed of a 1:1 eutectic mixture of 7% lidocaine and 7% tetracaine and was applied topically. S-Caine Peel was applied with a uniform thickness of approximately 1 mm and remained on the treatment area for 30 minutes (+/- 2 minutes).
Other Name: Pliaglis
|Placebo Comparator: Placebo Peel||
Drug: Placebo Peel
Placebo Peel applied topically with a uniform thickness of approximately 1 mm and remained on the treatment area for 30 minutes (+/- 2 minutes).
Other Name: Placebo
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 "top/right" or "bottom/left" 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 patient's right and left or top and bottom. Patients had a concurrent administration of the study drugs, with the appropriate study drug applied to the top/right treatment area first followed immediately by the other study drug applied to the bottom/left 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 (top/right treatment area removed first, followed immediately by removal of the other study drug from bottom/left treatment area), the investigator evaluated the treatment areas for erythema, edema, blanching and any adverse skin reaction.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00110760
|United States, Colorado|
|Englewood, Colorado, United States, 80113|
|United States, Tennessee|
|Tennessee Clinical Research Center|
|Nashville, Tennessee, United States, 37215|
|United States, Texas|
|J&S Studies, Inc.|
|Bryan, Texas, United States, 77802|
|Principal Investigator:||Michael Gold, MD||Tennessee Clinical Research Center|