S-Caine™ Peel (Skin Numbing Cream) to Treat Pain During Laser-Assisted Tattoo Removal in Adults

This study has been completed.
Information provided by:
ZARS Pharma Inc.
ClinicalTrials.gov Identifier:
First received: May 12, 2005
Last updated: September 21, 2005
Last verified: September 2005
There is pain associated with laser-assisted tattoo removal. For this reason, some form of anesthesia is commonly used to eliminate or minimize the pain. This anesthesia is usually a topical local anesthetic cream or ointment spread over the skin. The purpose of this study is to further estimate the effectiveness of S-Caine™ Peel (lidocaine 7% and tetracaine 7% cream) for treating pain during laser-assisted tattoo removal.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo Controlled, Paired Study Evaluating S-Caine™ Peel (Lidocaine 7% and Tetracaine 7% Cream) for Induction of Local Dermal Anesthesia for Laser-Assisted Tattoo Removal in Adults

Resource links provided by NLM:

Further study details as provided by ZARS Pharma Inc.:

Primary Outcome Measures:
  • To evaluate the efficacy of S-Caine Peel when applied for 60 minutes for induction of local dermal anesthesia prior to laser-assisted tattoo removal in adults

Secondary Outcome Measures:
  • To monitor the nature and frequency of adverse events (AEs) associated with the application of S-Caine Peel

Estimated Enrollment: 60
Estimated Study Completion Date: September 2005

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

Inclusion Criteria:

  • Patient is 18 years of age or older
  • Patient elects to undergo laser-assisted tattoo removal

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00110734

United States, New York
Laser and Skin Surgery Center of New York
New York, New York, United States, 10016
Sponsors and Collaborators
ZARS Pharma Inc.
  More Information

ClinicalTrials.gov Identifier: NCT00110734     History of Changes
Other Study ID Numbers: SCP-43-05 
Study First Received: May 12, 2005
Last Updated: September 21, 2005
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Depressants
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents

ClinicalTrials.gov processed this record on May 23, 2016