S-Caine™ Peel (Skin Numbing Cream) to Treat Pain During Non-Ablative Facial Laser Resurfacing in Adults

NCT00110747 | Completed Phase 3

• 1 other identifier: SCP-41-05
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 3

Brief Summary

Lasers are used for non-ablative resurfacing of facial rhytides, atrophic scars, and a variety of epidermal and dermal lesions. Pain associated with the non-ablative laser treatment has been described as moderate to severe. 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 if S-Caine Peel is effective in providing topical local dermal anesthesia for non-ablative facial laser resurfacing in adults.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Patient's evaluation of pain

  Patient's evaluation of pain using a 100 mm Visual Analog scale (VAS)

  30 minutes

Secondary Outcomes (1)

• Number of participants with adverse events

  30 minutes

Study Arms (2)

S-Caine Peel

EXPERIMENTAL

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

Placebo Peel

PLACEBO COMPARATOR

Drug: Placebo Peel

Interventions

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

S-Caine Peel comprising a 1:1 eutectic mixture of 7% lidocaine and 7% tetracaine was applied topically. A thin layer of the peel (approximately 1 mm in thickness) was applied and remained on the treatment area for 30 minutes (±2 minutes).

Also known as: Pliaglis

S-Caine Peel

Placebo Peel DRUG

Peel was applied topically. A thin layer of the peel (approximately 1 mm in thickness) was applied 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 non-ablative facial laser resurfacing procedure

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)

Midwest Cutaneous Research

Clinton Township, Michigan, 48038, United States

Location

Laser and Skin Surgery Center of New York

New York, New York, 10016, United States

Location

New York Dermatology

New York, New York, 10021, 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

• Tina Alster, MD

  Washington Institute of Dermatologic Laser Surgery

  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)