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

• ClinicalTrials.gov Identifier: NCT00107835
• Recruitment Status: Completed
• First Posted: April 11, 2005
• Last Update Posted: June 6, 2012
• Sponsor: ZARS Pharma Inc.
• Information provided by (Responsible Party): ZARS Pharma Inc.

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Pain	Drug: S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%)	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 408 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: May 2005
• Actual Primary Completion Date: September 2005
• Actual Study Completion Date: September 2005

Arms and Interventions

Arm	Intervention/treatment
Experimental: S-Caine Peel	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; Other Name: Pliaglis

Outcome Measures

Primary Outcome Measures :

1. Number of participants with adverse events [ Time Frame: 20-30 minutes ]
   To evaluate the safety of a single administration of S-Caine Peel in providing dermal anesthesia over intact skin prior to a minor and major dermal procedure in adults

Secondary Outcome Measures :

1. Adequacy of Anesthesia [ Time Frame: 20-30 minutes ]
   To evaluate the adequacy of anesthesia provided for the minor and major dermal procedure. The adequacy of anesthesia was evaluated by asking patients whether the study drug provided adequate pain relief for the procedure (yes or no), and by asking the investigator whether the study drug provided adequate anesthesia for the procedure (yes or no).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Patient is 18 years of age or older.
• Patient elects to undergo a minor or major dermal procedure.
• Patient is able to read and understand a written informed consent and has signed and dated a written informed consent.

Exclusion Criteria:

• Patient has known allergies, contraindications or sensitivities to lidocaine, tetracaine, or other local anesthetics of the amide or ester type or to any components of the test materials.
• Patient has known active atopic dermatitis at the designated treatment site.
• Patient has damaged, denuded or broken skin at the designated treatment site.
• Patient is pregnant or breastfeeding.
• Patient has participated in an investigational study or clinical trial of an unapproved drug within the previous 30 days.
• Patient has enrolled in any previous study involving S-Caine Peel.

Contacts and Locations

Locations

United States, Florida

International Dermatology Research Inc.

Miami, Florida, United States, 33144

United States, Michigan

Midwest Cutaneous Research

Clinton Township, Michigan, United States, 48038

United States, New York

Laser and Skin Surgery Center of New York

New York, New York, United States, 10016

United States, Tennessee

Tennessee Clinical Research Center

Nashville, Tennessee, United States, 37215

United States, Texas

Texas Dermatology Research Institute

Dallas, Texas, United States, 75230

Sponsors and Collaborators

ZARS Pharma Inc.

Investigators

• Principal Investigator: Alicia Barba, MD; International Dermatology Research

More Information

Additional Information:

Pain 

• Responsible Party: ZARS Pharma Inc.
• ClinicalTrials.gov Identifier: NCT00107835 History of Changes
• Other Study ID Numbers: SCP-45-05
• First Posted: April 11, 2005
• Last Update Posted: June 6, 2012
• Last Verified: June 2012

Keywords provided by ZARS Pharma Inc.:

Pain

Additional relevant MeSH terms:

Lidocaine; Tetracaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action