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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00107835
Recruitment Status : Completed
First Posted : April 11, 2005
Last Update Posted : June 6, 2012
Information provided by (Responsible Party):
ZARS Pharma Inc.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 408 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine

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

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).

Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00107835

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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.
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Principal Investigator: Alicia Barba, MD International Dermatology Research, Inc.
Additional Information:
Pain  This link exits the site

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Responsible Party: ZARS Pharma Inc. Identifier: NCT00107835    
Other Study ID Numbers: SCP-45-05
First Posted: April 11, 2005    Key Record Dates
Last Update Posted: June 6, 2012
Last Verified: June 2012
Keywords provided by ZARS Pharma Inc.:
Additional relevant MeSH terms:
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Anesthetics, Local
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