TattooNCT01624688
Optimizing Tattoo Removal: a Side-by-side Comparison in the Search for One Treatment Tattoo Removal
A study testing Tattoo Removal in people with Tattoo and Tattoo Removal, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Tattoo, Tattoo Removal
- What is being tested?
- Tattoo Removal
- Type of treatment
- Surgery or procedure
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wellman Center for Photomedicine
Boston, Massachusetts, 02114
About this study
The purpose of this study is to combine treatment options for tattoo removal in an attempt to completely remove a tattoo in one visit.
Read the 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.
- Conditions
- Tattoo, Tattoo Removal
- Being tested
- Tattoo Removal
- Keywords
- Tattoo, Tattoo Removal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tattoo RemovalProcedure or surgery
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Tattoo Clearance
Measured: 2 months after treatment
Secondary outcomes (2)
Patient's preferred removal technique
Measured: 2 months after treatment
Post treatment skin changes
inflammatory and pigmentary alterations and changes in skin texture after treatment
Measured: 2 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2012 (estimated)
- Study startJul 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TattooStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Rox Anderson, MD, Massachusetts General Hospital
- Investigators
- R. Rox Anderson, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01624688
- Sponsor's protocol ID
- 2011P001091
- Status last verified
- Oct 2019
- First submitted
- 19 Jun 2012
- Last updated
- 8 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Tattoo Removal: a Side-by-side Comparison in the Search for One Treatment Tattoo Removal
- ClinicalTrials.gov ID
- NCT01624688
- Acronym / sponsor ID
- 2011P001091
- Conditions
- Tattoo, Tattoo Removal
- Keywords
- Tattoo, Tattoo Removal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 21 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tattoo RemovalTattoo 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 | Procedure or surgery | – |
Primary outcome
Tattoo Clearance
Time frame: 2 months after treatment
2 secondary outcomes
Patient's preferred removal technique
Time frame: 2 months after treatment
Post treatment skin changes
Time frame: 2 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R. Rox Anderson, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tattoo Removal in people with Tattoo and Tattoo Removal, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tattoo Clearance (time frame: 2 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2019.