Optimizing Tattoo Removal: a Side-by-side Comparison in the Search for One Treatment Tattoo Removal

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Richard Rox Anderson, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01624688
First received: June 19, 2012
Last updated: June 27, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention
Tattoo
Tattoo Removal
Procedure: Tattoo Removal

Study Type: Interventional
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

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Tattoo Clearance [ Time Frame: 2 months after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Enrollment: 32
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)
Intervention Details:
    Procedure: Tattoo Removal
    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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01624688

Locations
United States, Massachusetts
Wellman Center for Photomedicine
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: R. Rox Anderson, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Richard Rox Anderson, MD, Professor Harvard Medical School, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01624688     History of Changes
Other Study ID Numbers: 2011P001091
Study First Received: June 19, 2012
Last Updated: June 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Tattoo
Tattoo Removal

ClinicalTrials.gov processed this record on October 20, 2014