S-Caine™ Peel (Skin Numbing Cream) to Treat Pain During Pulsed Dye Laser (PDL) Therapy in Adults
|Pain||Drug: S-Caine™ Peel (lidocaine and tetracaine topical 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:||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|
- Pain Intensity [ Time Frame: 20 minutes ]Patient's evaluation of procedural pain intensity using the 100 mm Visual Analog Scale (VAS).
- Number of participants with adverse events [ Time Frame: 20 minutes ]To monitor the nature and frequency of adverse events (AEs) associated with the application of S-Caine Peel
|Study Start Date:||June 2005|
|Study Completion Date:||October 2005|
|Primary Completion Date:||October 2005 (Final data collection date for primary outcome measure)|
|Experimental: S-Caine Peel||
Drug: S-Caine™ Peel (lidocaine and tetracaine topical cream 7%/7%)
S-Caine Peel, composed of a 1:1 (w:w) eutectic mixture of 7% lidocaine and 7% tetracaine, applied topically. S-Caine Peel applied at approximately 1 mm in thickness and remained on the treatment area for 20 minutes (±2 minutes).
Other Name: Pliaglis
|Placebo Comparator: Placebo Peel||
Drug: Placebo Peel
Placebo Peel applied topically at approximately 1 mm in thickness and remained on the treatment area for 20 minutes (±2 minutes).
Other Name: Placebo
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00110773
|United States, District of Columbia|
|Washington Institute of Dermatologic Laser Surgery|
|Washington, District of Columbia, United States, 20037|
|United States, Michigan|
|Midwest Cutaneous Research|
|Clinton Township, Michigan, United States, 48038|
|United States, New York|
|Laser and Skin Surgery Center of New York|
|New York, New York, United States, 10016|
|Principal Investigator:||Tina Alster, MD||Washington Institute of Dermatologic Laser Surgery|