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

NCT ID: NCT00110747

Last Updated: 2012-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2005-09-30

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

S-Caine Peel

Group Type: EXPERIMENTAL

S-Caine™ Peel (lidocaine and tetracaine topical cream 7%/7%)

Intervention Type: DRUG

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

Group Type: PLACEBO_COMPARATOR

Placebo Peel

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

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).

Intervention Type: DRUG

Other Intervention Names

Pliaglis; Placebo

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ZARS Pharma Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tina Alster, MD

Role: PRINCIPAL_INVESTIGATOR

Washington Institute of Dermatologic Laser Surgery

Locations

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

Countries

United States

Other Identifiers

SCP-41-05

Identifier Type: -

Identifier Source: org_study_id