S-Caine™ Peel (Skin Numbing Cream) to Treat Pain During Pulsed Dye Laser (PDL) Therapy in Adults

ZARS Pharma

Status and phase

Completed

Phase 3

Conditions

Pain

Treatments

Drug: S-Caine™ Peel (lidocaine and tetracaine topical cream 7%/7%)

Drug: Placebo Peel

Study type

Interventional

Funder types

Industry

Identifiers

NCT00110773

SCP-42-05

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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