Injection of dermal filler is used as an aesthetic treatment to fill in unwanted wrinkles and scars. There can be substantial pain associated with dermal filler injections. For this reason, local anesthesia is often used to eliminate or minimize the pain. This anesthesia can be administered by injection or through the use of topical creams and ointments.

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 dermal filler injections in adults.

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 for induction of local dermal anesthesia for dermal filler injection in adults
Secondary Outcomes: To monitor the nature and frequency of adverse events (AEs) associated with the use of S-Caine Peel
Expected Total Enrollment:  70

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 dermal filler injection in 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 previous clinical trial involving S-Caine Peel

Please refer to this study by ClinicalTrials.gov identifier  NCT00110760

Study ID Numbers:  SCP-40-05
Record last reviewed:  April 2005
Last Updated:  May 12, 2005
Record first received:  May 12, 2005
ClinicalTrials.gov Identifier:  NCT00110760
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-05-17