S-Caine™ Peel (Skin Numbing Cream) to Treat Pain During Non-Ablative Facial Laser Resurfacing in Adults

Phase 3

Completed

• Conditions: Pain
• Interventions: Drug: S-Caine™ Peel (lidocaine and tetracaine topical cream 7%/7%); Drug: Placebo Peel

• Registration Number: NCT00110747
• Lead Sponsor: ZARS Pharma Inc.

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 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 Timeline

• Study First Submitted: 2005-05-12
• Study First Submitted QC: 2005-05-12
• Study First Posted: 2005-05-13
• Study Start: 2005-06
• Primary Completion: 2005-09
• Study Completion: 2005-09
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-04
• Last Update Posted: 2012-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
S-Caine Peel	S-Caine™ Peel (lidocaine and tetracaine topical cream 7%/7%)	-
Placebo Peel	Placebo Peel	-

Primary Outcome Measures

Name	Time	Method
Patient's evaluation of pain	30 minutes	Patient's evaluation of pain using a 100 mm Visual Analog scale (VAS)

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events	30 minutes	To monitor the nature and frequency of adverse events (AEs) associated with the application of S-Caine Peel

Trial Locations

Locations (3)

Midwest Cutaneous Research; 🇺🇸 Clinton Township, Michigan, United States

Laser and Skin Surgery Center of New York; 🇺🇸 New York, New York, United States

New York Dermatology; 🇺🇸 New York, New York, United States