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

Further Study Details: 

Primary Outcomes: 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 Outcomes: To evaluate the adequacy of anesthesia provided for the minor and major dermal procedure
Expected Total Enrollment:  370

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.

Study ID Numbers:  SCP-45-05
Record last reviewed:  April 2005
Last Updated:  April 11, 2005
Record first received:  April 8, 2005
ClinicalTrials.gov Identifier:  NCT00107835
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-14