S-Caine™ Peel (Skin Numbing Cream) to Treat Pain During Pulsed Dye Laser (PDL) Therapy in Adults

NCT ID: NCT00110773

Last Updated: 2012-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2005-10-31

Brief Summary

Pulsed dye laser (PDL) on the face is painful. 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 the efficacy of S-Caine Peel for induction of local dermal anesthesia for PDL therapy in adults.

Detailed Description

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.

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, 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).

Placebo Peel

Group Type: PLACEBO_COMPARATOR

Placebo Peel

Intervention Type: DRUG

Placebo Peel applied topically at approximately 1 mm in thickness and remained on the treatment area for 20 minutes (±2 minutes).

Interventions

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).

Intervention Type: DRUG

Placebo Peel

Placebo Peel applied topically at approximately 1 mm in thickness and remained on the treatment area for 20 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 PDL therapy for the treatment of vascular lesions on the face

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 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

Washington Institute of Dermatologic Laser Surgery

Washington D.C., District of Columbia, United States

Midwest Cutaneous Research

Clinton Township, Michigan, United States

Laser and Skin Surgery Center of New York

New York, New York, United States

Countries

United States

Other Identifiers

SCP-42-05

Identifier Type: -

Identifier Source: org_study_id