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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00110747
• Other study ID #: SCP-41-05
• Status: Completed
• Phase: Phase 3
• First received: May 12, 2005
• Last updated: June 4, 2012
• Start date: June 2005
• Est. completion date: September 2005

Study information

• Verified date: June 2012
• Source: ZARS Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: September 2005
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• S-Caine™ Peel (lidocaine and tetracaine topical cream 7%/7%)
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).
• 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).

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
ZARS Pharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient's evaluation of pain	Patient's evaluation of pain using a 100 mm Visual Analog scale (VAS)	30 minutes	Yes
Secondary	Number of participants with adverse events	To monitor the nature and frequency of adverse events (AEs) associated with the application of S-Caine Peel	30 minutes	Yes