Optimizing Tattoo Removal: a Side-by-side Comparison in the Search for One Treatment Tattoo Removal
1 other identifier
interventional
32
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 19, 2012
CompletedFirst Posted
Study publicly available on registry
June 21, 2012
CompletedOctober 8, 2019
October 1, 2019
5 months
June 19, 2012
October 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tattoo Clearance
2 months after treatment
Secondary Outcomes (2)
Patient's preferred removal technique
2 months after treatment
Post treatment skin changes
2 months after treatment
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wellman Center for Photomedicine
Boston, Massachusetts, 02114, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
R. Rox Anderson, MD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Harvard Medical School
Study Record Dates
First Submitted
June 19, 2012
First Posted
June 21, 2012
Study Start
July 1, 2011
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
October 8, 2019
Record last verified: 2019-10