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

This study has been completed.

Sponsored by: ZARS Pharma Inc.
Information provided by: ZARS Pharma Inc.
ClinicalTrials.gov Identifier: NCT00107835
  Purpose

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 Intervention Phase
Pain
Drug: S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%)
Phase III

MedlinePlus related topics:   Anesthesia   

ChemIDplus related topics:   Tetracaine    Viractin    Lidocaine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by ZARS Pharma Inc.:

Primary Outcome Measures:
  • 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:
  • To evaluate the adequacy of anesthesia provided for the minor and major dermal procedure

Estimated Enrollment:   370
Study Start Date:   April 2005

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00107835

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.
  More Information


Pain  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   SCP-45-05
First Received:   April 8, 2005
Last Updated:   September 27, 2005
ClinicalTrials.gov Identifier:   NCT00107835
Health Authority:   United States: Food and Drug Administration

Keywords provided by ZARS Pharma Inc.:
Pain  

Study placed in the following topic categories:
Tetracaine
Lidocaine
Pain

Additional relevant MeSH terms:
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Cardiovascular Agents
Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions
Anesthetics, Local

ClinicalTrials.gov processed this record on September 23, 2008




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