Optimizing Tattoo Removal: a Side-by-side Comparison in the Search for One Treatment Tattoo Removal
Condition: Tattoo; Tattoo Removal
Study type: Interventional

Summary: 
      The purpose of this study is to combine treatment options for tattoo removal in an attempt to
      completely remove a tattoo in one visit.
    

Detailed description: 
      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.
    

Intervention name(s): Tattoo Removal
Intervention type(s): Procedure
Intervention description(s): Tattoo removal with q-switched laser treatment, repeated q-switched laser treatment, repeated q-switched laser treatment with fractional ablative laser treatment, and repeated q-switched laser treatment with fractional ablative laser treatment and then topical urea
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tattoo; Tattoo Removal