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

This study has been completed.
Sponsor:
Information provided by:
ZARS Pharma Inc.
ClinicalTrials.gov Identifier:
NCT00110734
First received: May 12, 2005
Last updated: September 21, 2005
Last verified: September 2005
History of Changes
  Purpose

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
Pain
 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:

U.S. FDA Resources

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
  Eligibility

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

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

Locations
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

No publications provided

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:
Tetracaine
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 23, 2013