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

NCT00110760 | Completed Phase 3

• 1 other identifier: SCP-40-05
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 3

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Number of participants with adverse events

  30 minutes

• Patient's evaluation of the adequacy of pain relief

  30 minutes

Study Arms (2)

S-Caine Peel

EXPERIMENTAL

Drug: S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%)

Placebo Peel

PLACEBO COMPARATOR

Drug: Placebo Peel

Interventions

S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%) DRUG

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).

Also known as: Pliaglis

S-Caine Peel

Placebo Peel DRUG

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

Also known as: Placebo

Placebo Peel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is 18 years of age or older
• Patient elects to undergo dermal filler injection in the face

You may not qualify if:

• 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

Sponsors & Collaborators

• ZARS Pharma Inc.: lead

Study Sites (3)

AboutSkin Dermatology

Englewood, Colorado, 80113, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

J&S Studies, Inc.

Bryan, Texas, 77802, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Michael Gold, MD

  Tennessee Clinical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2005
• First Posted: May 13, 2005
• Study Start: June 1, 2005
• Primary Completion: September 1, 2005
• Study Completion: September 1, 2005
• Last Updated: June 5, 2012

Record last verified: 2012-06

Locations

US (3)