Tattooing Clinical Trial
Official title:
The Efficacy of the Cupola Ultrasonic Tattoo Removal Device: A Prospective Single Blinded, Before-After Study Design
The study is designed to determine the efficacy of the Cupola tattoo removal device for tattoo removal.
The Cupola system is a non-invasive device for pigment/tattoo removal based on ultrasound
technology. The safety of the device was demonstrated in a previous pilot study approved by
the Herzog Helsinki committee #167-09, Ministry of Health April 2010 #HT-5293) showing that
no risk was associated with the procedure.
This study is designed to determine the efficacy of the device for tattoo removal in up to 6
treatments in different treatment intervals. Three areas of the tattoo that are similar in
size, color, and intensity will be chosen. One area will not be treated; the second will
receive 6 treatments in 2-3 week intervals; the third will receive 3 treatments in 4-6 week
intervals. The evaluations will include color measurements, photography, subject comfort and
skin condition.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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