TattoosNCT01811017
Clinical Evaluation of 755nm Alexandrite Laser Versus Nanosecond 755nm Alexandrite
A study testing 755nm Alexandrite Laser in people with Tattoos, run by Cynosure, Inc. at 1 site in United States.
Trial summary
Compare the efficacy of the 755nm Alexandrite laser to the nanosecond 755nm Alexandrite laser for the removal of unwanted tattoos using photographic evaluation and histological findings. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Tattoos
- What is being tested?
- 755nm Alexandrite Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to May 2013
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is a healthy male or female between 18 and 85 years old?
- Has unwanted non-cosmetic tattoo(s) and wishes to undergo laser treatments
- Is willing to consent to participate in the study.
- Is willing to shield the tattoo completely from sun exposure
- Signs informed consent form
- Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits.
Who cannot join
- Subjects who are unwilling to consent to tattoos
- Subjects mentally ill or incompetent
- Subjects is unwilling to have photographs taken and used in publications or scientific presentations
- Subjects who are prisoners
- Subjects with recent sun exposure and suntan in the area to be treated
- Allergic tattoos (hypersensitivity to tattoo ink)
Show all 16Show fewer
- History of vitiligo or keloidal scarring
- Tattoos located on the neck or face including cosmetic tattoos
- 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 (e.g. HIV)
- Subject is pregnant or nursing
- Use of oral isotretinoin within past 12 months
- History of squamous cell carcinoma or melanoma
- Is allergic to Lidocaine, tetracaine or Xylocaine with epinephrine.
- Has any other reason determined by the physician to be ineligible to participate in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Va Medical Center
Boston, Massachusetts, 02130
About this study
Compare the efficacy of the 755nm Alexandrite laser to the nanosecond 755nm Alexandrite laser for the removal of unwanted tattoos using photographic evaluation and histological findings.
- Conditions
- Tattoos
- Being tested
- 755nm Alexandrite Laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
755nm Alexandrite LaserDevice
755nm Alexandrite Laser
| Study group | Role | What they receive |
|---|---|---|
| 755nm Alexandrite Laser | Experimental | 755nm Alexandrite Laser Receives: Device: 755nm Alexandrite Laser |
| Nanosecond 755nm Alexandrite Laser | Experimental | Nanosecond 755nm Alexandrite Laser Receives: Device: 755nm Alexandrite Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Photographic Evaluation of Tattoo Clearance
Measured: up to 3 months post last treatment
Secondary outcomes (1)
Subject biopsy sampling
Histological evaluation of tissue samples pre-treatment and post-treatment
Measured: up to 3 months post last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2013 (estimated)
- Study startJun 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TattoosStudies of the same condition, open and under way.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cynosure, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patricia Krantz, Study director, Cynosure, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01811017
- Sponsor's protocol ID
- CYN12-PICO_MGH_TB
- Status last verified
- Feb 2014
- First submitted
- 6 Dec 2012
- Last updated
- 5 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of 755nm Alexandrite Laser Versus Nanosecond 755nm Alexandrite
- ClinicalTrials.gov ID
- NCT01811017
- Acronym / sponsor ID
- CYN12-PICO_MGH_TB
- Conditions
- Tattoos
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cynosure, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 14 Mar 2013 (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.
Compare the efficacy of the 755nm Alexandrite laser to the nanosecond 755nm Alexandrite laser for the removal of unwanted tattoos using photographic evaluation and histological findings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 755nm Alexandrite Laser | Experimental | Device: 755nm Alexandrite Laser755nm Alexandrite Laser |
| Nanosecond 755nm Alexandrite Laser | Experimental | Device: 755nm Alexandrite LaserNanosecond 755nm Alexandrite Laser |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Is a healthy male or female between 18 and 85 years old?
- Has unwanted non-cosmetic tattoo(s) and wishes to undergo laser treatments
- Is willing to consent to participate in the study.
- Is willing to shield the tattoo completely from sun exposure
- Signs informed consent form
Key exclusion criteria (16 listed)
- Subjects who are unwilling to consent to tattoos
- Subjects mentally ill or incompetent
- Subjects is unwilling to have photographs taken and used in publications or scientific presentations
- Subjects who are prisoners
- Subjects with recent sun exposure and suntan in the area to be treated
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 |
|---|---|---|
| 755nm Alexandrite Laser755nm Alexandrite Laser | Device | 755nm Alexandrite Laser, Nanosecond 755nm Alexandrite Laser |
Primary outcome
Photographic Evaluation of Tattoo Clearance
Time frame: up to 3 months post last treatment
1 secondary outcome
Subject biopsy sampling
Time frame: up to 3 months post last treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2014.
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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.
Patricia Krantz study director
Cynosure, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 755nm Alexandrite Laser in people with Tattoos, run by Cynosure, Inc. 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 6 inclusion and 16 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: withdrawn, as of the sponsor's last update on 5 Feb 2014. 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 was withdrawn before enrolling participants, so there are no results.
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?
Photographic Evaluation of Tattoo Clearance (time frame: up to 3 months post last 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 5 Feb 2014.