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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00110760
• Other study ID #: SCP-40-05
• Status: Completed
• Phase: Phase 3
• First received: May 12, 2005
• Last updated: June 4, 2012
• Start date: June 2005
• Est. completion date: September 2005

Study information

• Verified date: June 2012
• Source: ZARS Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 2005
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

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).
• 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).

Locations

Country	Name	City	State
United States	J&S Studies, Inc.	Bryan	Texas
United States	AboutSkin Dermatology	Englewood	Colorado
United States	Tennessee Clinical Research Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
ZARS Pharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Intensity	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	30 minutes	No
Secondary	Number of participants with adverse events	To monitor the nature and frequency of adverse events (AEs) associated with the use of S-Caine Peel	30 minutes	Yes
Secondary	Patient's evaluation of the adequacy of pain relief	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)?	30 minutes	No