- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00110747
S-Caine™ Peel (Skin Numbing Cream) to Treat Pain During Non-Ablative Facial Laser Resurfacing in Adults
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
Study Overview
Status
Conditions
Intervention / Treatment
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 patient's 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 Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Michigan
-
Clinton Township, Michigan, United States, 48038
- Midwest Cutaneous Research
-
-
New York
-
New York, New York, United States, 10016
- Laser and Skin Surgery Center of New York
-
New York, New York, United States, 10021
- New York Dermatology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient is 18 years of age or older
- Patient elects to undergo non-ablative facial laser resurfacing procedure
Exclusion Criteria:
- Patient is pregnant or breastfeeding
- Patient has participated in a clinical trial of an unapproved drug within the previous 30 days
- Patient has participated in any previous clinical trial involving S-Caine Peel
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: S-Caine Peel
|
S-Caine Peel comprising a 1:1 eutectic mixture of 7% lidocaine and 7% tetracaine was applied topically.
A thin layer of the peel (approximately 1 mm in thickness) was applied and remained on the treatment area for 30 minutes (±2 minutes).
Other Names:
|
Placebo Comparator: Placebo Peel
|
Peel was applied topically.
A thin layer of the peel (approximately 1 mm in thickness) was applied and remained on the treatment area for 30 minutes (±2 minutes).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient's evaluation of pain
Time Frame: 30 minutes
|
Patient's evaluation of pain using a 100 mm Visual Analog scale (VAS)
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with adverse events
Time Frame: 30 minutes
|
To monitor the nature and frequency of adverse events (AEs) associated with the application of S-Caine Peel
|
30 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tina Alster, MD, Washington Institute of Dermatologic Laser Surgery
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
- Tetracaine
Other Study ID Numbers
- SCP-41-05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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