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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ZARS Pharma Inc.
ClinicalTrials.gov Identifier:
NCT00110760
First received: May 12, 2005
Last updated: June 4, 2012
Last verified: June 2012
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by ZARS Pharma Inc.:

Primary Outcome Measures:
  • Pain Intensity [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    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:
  • Number of participants with adverse events [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
    To monitor the nature and frequency of adverse events (AEs) associated with the use of S-Caine Peel

  • Patient's evaluation of the adequacy of pain relief [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    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)?


Enrollment: 70
Study Start Date: June 2005
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00110760

Locations
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.
Investigators
Principal Investigator: Michael Gold, MD Tennessee Clinical Research Center
  More Information

No publications provided

Responsible Party: ZARS Pharma Inc.
ClinicalTrials.gov Identifier: NCT00110760     History of Changes
Other Study ID Numbers: SCP-40-05
Study First Received: May 12, 2005
Last Updated: June 4, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Tetracaine
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 17, 2014