This is a prospective study to evaluate the efficacy and safety of an accessory for laser tattoo removal in allowing multiple passes within a single treatment session.
This is a prospective study to evaluate the efficacy and safety of an accessory for laser tattoo removal in allowing multiple passes within a single treatment session. One half of the tattoo will be randomly assigned laser treatment utilizing the Device (the "Device half"); the other half will receive laser treatment without the Device and serve as the control (the "Control half"). Based on statistical analysis sample size calculations, 30 subjects will be enrolled. The tattoo must be no larger than approximately 2 ½" x 6" or 3" x 5" in size, such that ½ of the tattoo can be covered with a single patch. Each subject will receive a single Treatment Session consisting of 5 minutes. Investigators will administer the standard laser treatment to both the Device and Control sites using well-established tattoo-removal treatment parameters for the laser used. Subjects will return for follow up approximately one month post-treatment. The presence of side effects and adverse events will be assessed and recorded for both Device and Control sites immediately after treatment and at the 1-month follow-up visit.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
30
Application of Describe patch over tattoo for approximately 5 minutes during Q-switched laser treatment
Nashville Centre for Laser and Facial Surgery
Nashville, Tennessee, United States
Number of passes with Describe patch
Number of passes with Describe patch compared to laser only
Time frame: 5 minutes
Safety assessment: Overall rate and severity of all reported adverse events
Overall rate and severity of all reported adverse events
Time frame: immediate post treatment, 1-month post tx
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