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

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ClinicalTrials.gov Identifier: NCT00110773
Recruitment Status : Completed
First Posted : May 13, 2005
Last Update Posted : June 5, 2012
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Pain Drug: S-Caine™ Peel (lidocaine and tetracaine topical cream 7%/7%) Drug: Placebo Peel Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : June 2005
Primary Completion Date : October 2005
Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: S-Caine Peel 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
Placebo Comparator: Placebo Peel 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

Outcome Measures

Primary Outcome Measures :
  1. Pain Intensity [ Time Frame: 20 minutes ]
    Patient's evaluation of procedural pain intensity using the 100 mm Visual Analog Scale (VAS).

Secondary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: 20 minutes ]
    To monitor the nature and frequency of adverse events (AEs) associated with the application of S-Caine Peel

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00110773

United States, District of Columbia
Washington Institute of Dermatologic Laser Surgery
Washington, District of Columbia, United States, 20037
United States, Michigan
Midwest Cutaneous Research
Clinton Township, Michigan, United States, 48038
United States, New York
Laser and Skin Surgery Center of New York
New York, New York, United States, 10016
Sponsors and Collaborators
ZARS Pharma Inc.
Principal Investigator: Tina Alster, MD Washington Institute of Dermatologic Laser Surgery
More Information

Responsible Party: ZARS Pharma Inc.
ClinicalTrials.gov Identifier: NCT00110773     History of Changes
Other Study ID Numbers: SCP-42-05
First Posted: May 13, 2005    Key Record Dates
Last Update Posted: June 5, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action