Tattoo Removal Clinical Trial
Official title:
Optimizing Tattoo Removal: a Side-by-side Comparison in the Search for One Treatment Tattoo Removal
The purpose of this study is to combine treatment options for tattoo removal in an attempt to completely remove a tattoo in one visit.
Efficient tattoo removal is of special concern to dermatology, where tattoo removal is a
common request. Current tattoo removal techniques using once monthly treatment with
quality-switched (QS) lasers are relatively effective, but not efficient. Numerous treatments
are required and complete removal of ink is usually rare, making the process time-consuming,
expensive and, sometimes, disappointing. The broad objective of this study is to combine
effective methods for tattoo removal based on current knowledge to establish a protocol which
significantly improves laser tattoo removal, aiming to selectively remove most tattoos in one
office visit.
The proposed study is a prospective, side-by-side comparison of four tattoo treatment
protocols using a combination of ablative fractional and q-switched (QS) laser techniques. 32
subjects with tattoos recruited from the community will receive all four treatments, one on
each randomly-assigned, equal quadrant of the same tattoo. The different treatment protocols
are as follows: 1. one round of QS laser treatment, which is the current treatment standard
2. four repeat treatments with the QS laser with a 20 minute delay in between 3. four repeat
treatments at 20 minute intervals with the QS laser combined with an ablative fractional
laser treatment 4. four repeat treatments at 20 minute intervals with the QS laser plus
treatment with the ablative fractional laser, in combination with topical urea application.
Following this initial round of treatments, the subject will have the option to choose his or
her preferred treatment protocol which will then be used to treat the entire tattoo again one
month later. Previous studies indicate that the majority of tattoos will be completely or
nearly completely removed in this study, providing a potential benefit to those who enroll in
the study. The primary measures of efficacy are (a) blinded evaluation of improvement from
standard digital photographs taken before and after the treatments, including number of
tattoos that are completely gone, and (b) digital analysis of tattoo removal from those
photos. Other study endpoints include patient's preferred removal technique, evaluation of
tattoo ink on dressings, inflammatory and pigmentary alterations and changes in skin texture.
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