NCT00107835

Safety Study of S-Caine Peel (Skin Numbing Cream) Before a Painful Dermatologic Procedure in Adults

An Open-Label Safety Study to Evaluate the Use of S-Caine™ Peel (Lidocaine 7% and Tetracaine 7% Cream) in Adult Patients Undergoing a Minor or Major Dermal Procedure

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 408 (actual)
• Sponsor: ZARS Pharma Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety of one treatment of S-Caine™ Peel (skin numbing cream) applied on healthy skin before a painful dermatologic procedure in adults. This study will also evaluate how well the S-Caine™ Peel eases the pain of the procedure.

Detailed description

The practice of dermatology is seeing a rise in the number of surgical and laser procedures as technological advances have expanded the number of conditions amenable to these evolving therapies. Skin biopsies, shave excisions, deep excisions, electro-surgical procedures, intralesional injections, and laser surgery are frequently performed by dermatologists on a daily basis. Some pain accompanies almost all of these procedures, and a local anesthetic is commonly used. Traditionally, intracutaneous injection of lidocaine (with or without epinephrine) has been the anesthetic of choice. However, patients undergoing these procedures are often afraid of needles and syringes and the pain associated with injections. As a result, topical anesthetic agents have been explored and developed as painless alternatives to injected anesthesia. S-Caine™ Peel (lidocaine 7% and tetracaine 7% cream) consists of a new eutectic formulation of lidocaine and tetracaine. S-Caine Peel is a topical local anesthetic cream that forms a pliable peel on the skin when exposed to air. S-Caine Peel is not occluded during application. The purpose of this study is to gain additional safety information for S-Caine Peel when used in minor and major dermal procedures in adults.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%)	S-Caine Peel comprising a 1:1 eutectic mixture of 7% lidocaine, and 7% tetracaine was applied topically. The study drug remained on the treatment area for 20-30 minutes for minor dermal procedures and 60 minutes for major dermal procedures

Timeline

• Start date: 2005-05-01
• Primary completion: 2005-09-01
• Completion: 2005-09-01
• First posted: 2005-04-11
• Last updated: 2012-06-06

Locations

5 sites across 1 country: United States