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S-Caine™ Peel (Skin Numbing Cream) to Treat Pain During Skin Filler Injection in the Face

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00110760
Recruitment Status : Completed
First Posted : May 13, 2005
Last Update Posted : June 5, 2012
Information provided by (Responsible Party):
ZARS Pharma Inc.

Brief Summary:

Injection of dermal filler is used as an aesthetic treatment to fill in unwanted wrinkles and scars. There can be substantial pain associated with dermal filler injections. For this reason, local anesthesia is often used to eliminate or minimize the pain. This anesthesia can be administered by injection or through the use of topical creams and ointments.

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 if S-Caine Peel is effective in providing topical local dermal anesthesia for dermal filler injections in adults.

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

Detailed Description:

This study was a randomized, double-blind, placebo controlled, paired study to evaluate the efficacy of S-Caine Peel for local dermal anesthesia for facial dermal filler injection in 70 adults. The study was multi-center, with 3 centers participating.

Patients who presented to the study center for a dermal filler injection procedure and who met study entry criteria were invited to participate in the study. At the screening visit, the study, including potential risks and benefits, was clearly explained to each patient. A written and dated informed consent was obtained from each patient. A medical history was obtained including skin type, demographic data, and the use of concomitant medications. A brief physical examination was performed (a skin examination at the study treatment area and basic vital signs), and a urine pregnancy test was obtained for females of childbearing potential.

At the procedure visit, patients who met the eligibility criteria were assigned the lowest available sequential patient number. The randomization determined the placement of the S-Caine Peel and placebo with the active study drug applied to either the "top/right" or "bottom/left" treatment area and the placebo applied to the alternate treatment area. The treatment areas were defined as 2 similar anatomical locations that required similar amounts of dermal filler (as measured in mLs injected, and number of injections) administered. The point of reference for these designations was the patient's right and left or top and bottom. Patients had a concurrent administration of the study drugs, with the appropriate study drug applied to the top/right treatment area first followed immediately by the other study drug applied to the bottom/left treatment area. Study drug application was double-blind. The study drugs were applied with a uniform thickness of approximately 1 mm and remained on the skin for 30 minutes (+/- 2 minutes).

Upon removal of the study drugs (top/right treatment area removed first, followed immediately by removal of the other study drug from bottom/left treatment area), the investigator evaluated the treatment areas for erythema, edema, blanching and any adverse skin reaction.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo Controlled, Paired Study Evaluating S-Caine™ Peel (Lidocaine 7% and Tetracaine 7% Cream)for Induction of Local Dermal Anesthesia for Dermal Filler Injection on the Face of Adults
Study Start Date : June 2005
Actual Primary Completion Date : September 2005
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: S-Caine Peel Drug: S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%)
S-Caine Peel was composed of a 1:1 eutectic mixture of 7% lidocaine and 7% tetracaine and was applied topically. S-Caine Peel was applied with a uniform thickness of approximately 1 mm and remained on the treatment area for 30 minutes (+/- 2 minutes).
Other Name: Pliaglis

Placebo Comparator: Placebo Peel Drug: Placebo Peel
Placebo Peel applied topically with a uniform thickness of approximately 1 mm and remained on the treatment area for 30 minutes (+/- 2 minutes).
Other Name: Placebo

Primary Outcome Measures :
  1. Pain Intensity [ Time Frame: 30 minutes ]
    Patient's evaluation of procedural pain intensity using the VAS. Immediately after completion of the dermal filler injections in each treatment area, patients completed a 100 mm horizontal VAS where 0 mm = no pain and 100 mm = the worst pain you can imagine

Secondary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: 30 minutes ]
    To monitor the nature and frequency of adverse events (AEs) associated with the use of S-Caine Peel

  2. Patient's evaluation of the adequacy of pain relief [ Time Frame: 30 minutes ]
    After the dermal filler procedure, each patient was asked to evaluate the efficacy of each study drug by answering the following questions: (i) Did this study drug provide adequate pain relief for the procedure (yes/no)? ; (ii) Would you have topical anesthesia administered using this study drug again if given the option (yes/no)?

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  • Patient is 18 years of age or older
  • Patient elects to undergo dermal filler injection in 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 previous clinical trial involving S-Caine Peel

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 identifier (NCT number): NCT00110760

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United States, Colorado
AboutSkin Dermatology
Englewood, Colorado, United States, 80113
United States, Tennessee
Tennessee Clinical Research Center
Nashville, Tennessee, United States, 37215
United States, Texas
J&S Studies, Inc.
Bryan, Texas, United States, 77802
Sponsors and Collaborators
ZARS Pharma Inc.
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Principal Investigator: Michael Gold, MD Tennessee Clinical Research Center
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Responsible Party: ZARS Pharma Inc. Identifier: NCT00110760    
Other Study ID Numbers: SCP-40-05
First Posted: May 13, 2005    Key Record Dates
Last Update Posted: June 5, 2012
Last Verified: June 2012
Additional relevant MeSH terms:
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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