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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%)

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 Type: Interventional
• Enrollment (Actual): 408
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33144
      • International Dermatology Research Inc.
  • Michigan
    • Clinton Township, Michigan, United States, 48038
      • Midwest Cutaneous Research
  • New York
    • New York, New York, United States, 10016
      • Laser and Skin Surgery Center of New York
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Tennessee Clinical Research Center
  • Texas
    • Dallas, Texas, United States, 75230
      • Texas Dermatology Research Institute

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Pliaglis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events	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	20-30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adequacy of Anesthesia	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).	20-30 minutes

Collaborators and Investigators

• Sponsor: ZARS Pharma Inc.
• Investigators: Principal Investigator: Alicia Barba, MD, International Dermatology Research, Inc.

Publications and helpful links

Helpful Links

• Pain

Study record dates

Study Major Dates

• Study Start: May 1, 2005
• Primary Completion (Actual): September 1, 2005
• Study Completion (Actual): September 1, 2005

Study Registration Dates

• First Submitted: April 8, 2005
• First Submitted That Met QC Criteria: April 8, 2005
• First Posted (Estimate): April 11, 2005

Study Record Updates

• Last Update Posted (Estimate): June 6, 2012
• Last Update Submitted That Met QC Criteria: June 4, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Pain
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Tetracaine
• Other Study ID Numbers: SCP-45-05