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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ZARS Pharma Inc.
ClinicalTrials.gov Identifier:
NCT00110773
First received: May 12, 2005
Last updated: June 4, 2012
Last verified: June 2012

May 12, 2005
June 4, 2012
June 2005
October 2005   (final data collection date for primary outcome measure)
Pain Intensity [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
Patient's evaluation of procedural pain intensity using the 100 mm Visual Analog Scale (VAS).
To evaluate the efficacy of S-Caine Peel, when applied for 20 minutes, for induction of local dermal anesthesia before PDL therapy in adults
Complete list of historical versions of study NCT00110773 on ClinicalTrials.gov Archive Site
Number of participants with adverse events [ Time Frame: 20 minutes ] [ Designated as safety issue: Yes ]
To monitor the nature and frequency of adverse events (AEs) associated with the application of S-Caine Peel
To monitor the nature and frequency of adverse events (AEs) associated with the application of S-Caine Peel
Not Provided
Not Provided
 
S-Caine™ Peel (Skin Numbing Cream) to Treat Pain During Pulsed Dye Laser (PDL) Therapy in Adults
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pain
  • Drug: S-Caine™ Peel (lidocaine and tetracaine topical cream 7%/7%)
    S-Caine Peel, composed of a 1:1 (w:w) eutectic mixture of 7% lidocaine and 7% tetracaine, applied topically. S-Caine Peel applied at approximately 1 mm in thickness and remained on the treatment area for 20 minutes (±2 minutes).
    Other Name: Pliaglis
  • Drug: Placebo Peel
    Placebo Peel applied topically at approximately 1 mm in thickness and remained on the treatment area for 20 minutes (±2 minutes).
    Other Name: Placebo
  • Experimental: S-Caine Peel
    Intervention: Drug: S-Caine™ Peel (lidocaine and tetracaine topical cream 7%/7%)
  • Placebo Comparator: Placebo Peel
    Intervention: Drug: Placebo Peel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
October 2005
October 2005   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00110773
SCP-42-05
No
ZARS Pharma Inc.
ZARS Pharma Inc.
Not Provided
Principal Investigator: Tina Alster, MD Washington Institute of Dermatologic Laser Surgery
ZARS Pharma Inc.
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP