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.

Study Overview

• Status: Completed
• Conditions: Tattoo Removal; Tattoo
• Intervention / Treatment: Procedure: Tattoo Removal

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Wellman Center for Photomedicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects between the ages of 18 and 50 years old, male or female.
• Subjects with tattoos that are between 16 and 400 cm2, both amateur and professional
• Willingness to participate in the study
• Willingness to shield tattoo completely from sun exposure
• Willingness to receive EXPERIMENTAL treatment
• Informed consent agreement signed by the subject
• Willingness to follow the treatment schedule and post treatment care requirements

Exclusion Criteria:

• Subjects with recent sun exposure and suntan in the area to be treated
• Allergic tattoos (hypersensitivity to tattoo ink)
• History of vitiligo
• Tattoos located on the neck or face
• Subjects unwilling to tolerate partial removal of the tattoo in this study
• Infection or skin disease in the area to be treated
• Subjects who are immunosuppressed
• Subject is unable to comply with treatment, home care or follow-up visits
• Subject is pregnant or nursing
• Allergy to lidocaine
• Liver failure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Tattoo Clearance	2 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's preferred removal technique		2 months after treatment
Post treatment skin changes	inflammatory and pigmentary alterations and changes in skin texture after treatment	2 months after treatment

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: June 19, 2012
• First Submitted That Met QC Criteria: June 19, 2012
• First Posted (Estimate): June 21, 2012

Study Record Updates

• Last Update Posted (Actual): October 8, 2019
• Last Update Submitted That Met QC Criteria: October 4, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Tattoo Removal; Tattoo
• Other Study ID Numbers: 2011P001091