Pulsed dye laser (PDL) on the face is painful. 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 the efficacy of S-Caine Peel for induction of local dermal anesthesia for PDL therapy in adults.

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

Further Study Details: 

Primary Outcomes: To evaluate the efficacy of S-Caine Peel, when applied for 20 minutes, for induction of local dermal anesthesia before PDL therapy 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:  80

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 PDL therapy for the treatment of vascular lesions on the face

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 clinical trial involving S-Caine Peel

Please refer to this study by ClinicalTrials.gov identifier  NCT00110773

Study ID Numbers:  SCP-42-05
Record last reviewed:  April 2005
Last Updated:  May 12, 2005
Record first received:  May 12, 2005
ClinicalTrials.gov Identifier:  NCT00110773
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-05-17