Optimizing Tattoo Removal: a Side-by-side Comparison in the Search for One Treatment Tattoo Removal
Recruitment status was Active, not recruiting
The purpose of this study is to combine treatment options for tattoo removal in an attempt to completely remove a tattoo in one visit.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Optimizing Tattoo Removal: a Side-by-side Comparison in the Search for One Treatment Tattoo Removal|
- Tattoo Clearance [ Time Frame: 2 months after treatment ] [ Designated as safety issue: No ]
- Patient's preferred removal technique [ Time Frame: 2 months after treatment ] [ Designated as safety issue: No ]
- Post treatment skin changes [ Time Frame: 2 months after treatment ] [ Designated as safety issue: Yes ]inflammatory and pigmentary alterations and changes in skin texture after treatment
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Procedure: Tattoo Removal
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01624688
|United States, Massachusetts|
|Wellman Center for Photomedicine|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||R. Rox Anderson, MD||Massachusetts General Hospital|