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	Treatment or Intervention	Phase
Pain	Drug: S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%)	Phase III

Further Study Details: 

Primary Outcomes: 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 Outcomes: To monitor the nature and frequency of adverse events (AEs) associated with the application of S-Caine Peel
Expected Total Enrollment:  60

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00110734

Study ID Numbers:  SCP-43-05
Record last reviewed:  April 2005
Last Updated:  May 12, 2005
Record first received:  May 12, 2005
ClinicalTrials.gov Identifier:  NCT00110734
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-05-17