Clinical trial NCT00107835: Safety Study of S-Caine Peel (Skin Numbing Cream) Before a Painful Dermatologic Procedure in Adults
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: Pain
Lead sponsor: ZARS Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2005-04-11
Enrollment: 408
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: 20-30 minutes
Secondary outcomes:
measure: Adequacy of Anesthesia
timeFrame: 20-30 minutes
Other outcomes:
Locations:
city: Miami
country: United States
facility: International Dermatology Research Inc.
state: Florida
city: Clinton Township
country: United States
facility: Midwest Cutaneous Research
state: Michigan
city: New York
country: United States
facility: Laser and Skin Surgery Center of New York
state: New York
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
city: Dallas
country: United States
facility: Texas Dermatology Research Institute
state: Texas
Study officials:
affiliation: International Dermatology Research, Inc.
name: Alicia Barba, MD
role: PRINCIPAL_INVESTIGATOR
References: