Healthy Clinical Trial
Official title:
A Prospective, Open Label, Non Randomized, First-In-Man (Feasibility) Study to Evaluate the Safety and Effectiveness of the Eraser Tattoo Removal Device
A new mechanical device is evaluated for tattoo removal, comparing two types of needle washing fluids. 30 healthy subjects with tattoos will be treated. The study hypothesis is that the device can be used to achieve satisfactory tattoo removal.
The new device (Eraser TM) uses multiple needles action with a washing fluid to remove
tattoos. Healthy patients who wish to remove a tattoo will be enrolled. The study will test
the removal of a small part of the tattoo (5cm2 area). Treatment lasts about 20 minutes
(with local analgesia if needed), after which an absorptive bandage is put over the treated
area for an hour and removed. Treatment may be performed using one of two washing fluids.
For one of them, blood samples for material blood level will be taken before and several
times after treatment. Pictures of the tattooed area being removed will be taken before and
after treatment, and at each follow-up evaluation.
Follow up evaluations will be performed at 1 week, two weeks, one month and two months post
treatment. Overall health and skin condition will be evaluated, and the tattoo area will be
pictured. Efficacy of tattoo removal will be evaluated after two months, by visual
estimation of the percent area that reacted to treatment, and the change in brightness (both
evaluated on a 1-5 analog scale). Depending on the result of tattoo removal, and on skin
condition, the study treatment will be stopped (if treatment is successful), or may be
repeated (up to a limit of two additional times) if the tattoo was not completely removed.
The results of tattoo removal using both washing fluids will be analyzed and compared. A
result of 3 or more on the brightness change scale will be considered as a successful
treatment.
Pharmacokinetic data for washing fluid no. 2 will be collected and analyzed, to provide Cmax
and AUC.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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