Unwanted TattoosNCT02110095
Picosure Alexandrite Laser for the Treatment of Unwanted Tattoos
A study testing Picosure Laser System in people with Unwanted Tattoos, run by Cynosure, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the Picosure Laser System for the treatment of unwanted tattoos. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Unwanted Tattoos
- What is being tested?
- Picosure Laser System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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.
- Is willing to consent to participate in the study.
- 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.
- The tattoo must include red pigment.
Who cannot join
- Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
- Is hypersensitive to light exposure OR takes photo sensitized medication.
- Has active or localized systemic infections.
- Has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to the heavy use of aspirin {greater than 81 mg per day}).
- Has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
- Is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 3 months prior to entering this study.
Show all 14Show fewer
- Has used Accutane within 6 months prior to enrollment.
- Has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
- Has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
- Has a history of keloids.
- Has evidence of compromised wound healing.
- Has a history of basal cell carcinoma, squamous cell carcinoma or melanoma.
- Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications or has an autoimmune disorder.
- Is allergic to topical lidocaine or topical steroids.
Trial locations and contacts
1 site in 1 country.
United States1 site
Skin Care Physicians
Chestnut Hill, Massachusetts, 02467
About this study
The purpose of this study is to evaluate the Picosure Laser System for the treatment of unwanted tattoos.
- Conditions
- Unwanted Tattoos
- Being tested
- Picosure Laser System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Picosure Laser SystemDevice
Picosure Laser System for the Treatment of Unwanted Tattoos
| Study group | Role | What they receive |
|---|---|---|
| Picosure Laser System | Experimental | Picosure Laser System for the treatment of unwanted tattoos Receives: Device: Picosure Laser System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Tattoo Clearance
Tattoo clearance will be measured using baseline and 2 month post treatment photos using a photographic scale. The scale ranges from 0 to 10, where 10 is 100% improvement from the baseline photo.
Measured: 2 months post last treatment
Secondary outcomes (1)
Physician Satisfaction Questionnaire
This measures the physician satisfaction from 1 to 5, where 5 is the most satisfied.
Measured: 2 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 posted10 Apr 2014 (estimated)
- Study startJan 2014
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Unwanted 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 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
- NCT02110095
- Sponsor's protocol ID
- CYN14-PICO-MULTI-JD
- Status last verified
- Nov 2020
- First submitted
- 8 Apr 2014
- Last updated
- 11 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Picosure Alexandrite Laser for the Treatment of Unwanted Tattoos
- ClinicalTrials.gov ID
- NCT02110095
- Acronym / sponsor ID
- CYN14-PICO-MULTI-JD
- Conditions
- Unwanted Tattoos
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Cynosure, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 10 Apr 2014 (estimated)
- Results
- Posted 11 Dec 2020
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 evaluate the Picosure Laser System for the treatment of unwanted tattoos.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Picosure Laser System | Experimental | Device: Picosure Laser SystemPicosure Laser System for the treatment of unwanted tattoos |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Is a healthy male or female between 18 and 85 years old.
- Is willing to consent to participate in the study.
- 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.
- The tattoo must include red pigment.
Key exclusion criteria (14 listed)
- Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
- Is hypersensitive to light exposure OR takes photo sensitized medication.
- Has active or localized systemic infections.
- Has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to the heavy use of aspirin {greater than 81 mg per day}).
- Has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research 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 |
|---|---|---|
| Picosure Laser SystemPicosure Laser System for the Treatment of Unwanted Tattoos | Device | Picosure Laser System |
Primary outcome
Number of Patients With Tattoo Clearance
Time frame: 2 months post last treatment
Tattoo clearance will be measured using baseline and 2 month post treatment photos using a photographic scale. The scale ranges from 0 to 10, where 10 is 100% improvement from the baseline photo.
1 secondary outcome
Physician Satisfaction Questionnaire
Time frame: 2 months post last treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 Picosure Laser System in people with Unwanted 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 4 inclusion and 14 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 11 Dec 2020. 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?
Yes. Results are posted in the registry (first posted 11 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients With Tattoo Clearance (time frame: 2 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 11 Dec 2020.