Clinical trial NCT00110773: S-Caine™ Peel (Skin Numbing Cream) to Treat Pain During Pulsed Dye Laser (PDL) Therapy in Adults
Official title: A Randomized, Double-Blind, Placebo Controlled, Parallel Study Evaluating the Efficacy of S-Caine™ Peel (Lidocaine 7% and Tetracaine 7% Cream) to Provide Local Dermal Anesthesia for Pulsed Dye Laser Therapy in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Lead sponsor: ZARS Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2005-05-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pulsed dye laser (PDL) on the face is painful. For this reason, local anesthesia is commonly used to eliminate or minimize the pain. S-Caine™ Peel (lidocaine 7% and tetracaine 7% cream) is a eutectic formulation of lidocaine and tetracaine. The purpose of this study is to evaluate the efficacy of S-Caine Peel for induction of local dermal anesthesia for PDL therapy in adults.

Detailed description: This was a multi-center (5 centers), double-blind, placebo-controlled, parallel study that included 80 adults who met all the eligibility criteria and who were undergoing PDL therapy for the treatment of vascular lesions on the face.

During the screening visit, the study, including potential risks and benefits, was clearly explained to each patient, and written informed consent was obtained from each patient. The screening visit also included: evaluating eligibility criteria, obtaining a medical history (including skin type, demographic data, and concomitant medications), a brief physical examination, and a urine pregnancy test (for women of childbearing potential). The screening visit could be completed on the same day as the procedure visit.

At the procedure visit, eligible patients were assigned the next available sequential patient number. By having a patient number assigned to them, patients were randomized to receive S-Caine Peel or placebo on the facial treatment area.

The surface area of the intended treatment area was determined (up to 200 cm2). A thin layer (approximately 1 mm or the thickness of a dime) of the study drug was applied evenly across the area to be treated. The study drug was applied for 20 minutes (±2 minutes).

Immediately following removal of the study drug, the investigator performed an evaluation of skin reactions, assessing the treatment area for erythema, edema and blanching or any other adverse skin reaction.

Eligibility criteria: Inclusion Criteria:

* Patient is 18 years of age or older
* Patient elects to undergo PDL therapy for the treatment of vascular lesions on the face

Exclusion Criteria:

* Patient is pregnant or breastfeeding
* Patient has participated in a clinical trial of an unapproved drug within the previous 30 days
* Patient has participated in any clinical trial involving S-Caine Peel

Primary outcomes:
measure: Pain Intensity
timeFrame: 20 minutes
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington Institute of Dermatologic Laser Surgery
state: District of Columbia
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
Study officials:
affiliation: Washington Institute of Dermatologic Laser Surgery
name: Tina Alster, MD
role: PRINCIPAL_INVESTIGATOR
References: