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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ZARS Pharma Inc.
ClinicalTrials.gov Identifier:
NCT00107835
First received: April 8, 2005
Last updated: June 4, 2012
Last verified: June 2012
  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 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by ZARS Pharma Inc.:

Primary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: 20-30 minutes ] [ Designated as safety issue: Yes ]
    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:
  • Adequacy of Anesthesia [ Time Frame: 20-30 minutes ] [ Designated as safety issue: No ]
    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).


Enrollment: 408
Study Start Date: May 2005
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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.
Investigators
Principal Investigator: Alicia Barba, MD International Dermatology Research
  More Information

Additional Information:
Pain  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: ZARS Pharma Inc.
ClinicalTrials.gov Identifier: NCT00107835     History of Changes
Other Study ID Numbers: SCP-45-05
Study First Received: April 8, 2005
Last Updated: June 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by ZARS Pharma Inc.:
Pain

Additional relevant MeSH terms:
Lidocaine
Tetracaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014