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

NCT00110747 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2012-06-05

No results posted yet for this study

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

Interventions

DRUG

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

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).

DRUG

Placebo Peel

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).

Sponsors & Collaborators

  • ZARS Pharma Inc.

    lead INDUSTRY

Principal Investigators

  • Tina Alster, MD · Washington Institute of Dermatologic Laser Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2005-09-30
Completion
2005-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00110747 on ClinicalTrials.gov