Pain
Conditions
Brief summary
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.
Interventions
Sponsors
ZARS Pharma Inc.
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| To monitor the nature and frequency of adverse events (AEs) associated with the application of S-Caine Peel | — |
Countries
United States
Outcome results
None listed