Unwanted TattoosNCT02103153

Clinical Evaluation of the Picosure 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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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 65 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: 44 participants
Where: 1 siteUnited States
Study dates: Sep 2013to Jan 2017
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Is a healthy non-smoking (must have quit 6 months prior) male or female between 18 and 65 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
Has unwanted non-cosmetic tattoo containing red ink, that has not previously been treated, and wishes to undergo laser treatment

Who cannot join

The subject is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
The subject is hypersensitive to light exposure OR takes photo sensitized medication.
The subject has active or localized systemic infections.
The subject has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy {greater than 81 mg per day}).
The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
The subject 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 13Show fewer

The subject has used Accutane within 6 months prior to enrollment.
The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
The subject has a history of keloids.
The subject has evidence of compromised wound healing.
The subject has a history of basal cell carcinoma, squamous cell carcinoma or melanoma.
The subject has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications or has an autoimmune disorder.

Trial locations and contacts

1 site in 1 country.

United States1 site

Laser & Skin Surgery Center of New York
New York, New York, 10016

Other trials in United States

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

Study groups in NCT02103153
Study group	Role	What they receive
Picosure Laser System	Experimental	Not described Receives: Device: Picosure Laser System

What is being measured

The primary outcome is the main question the study is designed to answer.

Tattoo Clearance Percentage Using a Photographic Scale
Clearance will be measured using a clearance aesthetic improvement scale. This scale ranges from 0% to 100%, where 0% is 0% tattoo cleared compared to the baseline tattoo, and 100% is 100% of tattoo cleared compared to the baseline tattoo.
Measured: 1-3 month follow up post each subject's last treatment, an average of 17.5 months

Secondary outcomes (2)

Investigator Satisfaction
Questionnaires were used to assess Investigator satisfaction at the post last treatment follow up visit with their cosmetic results when compared to baseline photos using a four point scale ranging from "extremely satisfied" (3) to "extremely dissatisfied" (0).
Measured: Baseline and 2 months post last treatment follow up (+/- 1 month)
Subject Satisfaction
Questionnaires were used to assess Subject satisfaction at the post last treatment follow up visit with their cosmetic results when compared to baseline photos using a four point scale ranging from "extremely satisfied" (3) to "extremely dissatisfied" (0).
Measured: Baseline and 2 months post last treatment follow up (+/- 1 month)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2013Jan 2017

First posted3 Apr 2014 (estimated)
Study startSep 2013
Primary completionJan 2017
Study completionJan 2017

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: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02103153
Sponsor's protocol ID: CYN13-PICO532-RG5
Status last verified: Apr 2021
First submitted: 31 Mar 2014
Last updated: 28 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of the Picosure Laser for the Treatment of Unwanted Tattoos
ClinicalTrials.gov ID: NCT02103153
Acronym / sponsor ID: CYN13-PICO532-RG5
Conditions: Unwanted Tattoos
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Cynosure, Inc.Industry (pharma, biotech, devices)
Study start: Sep 2013
Primary completion: Jan 2017 (actual)
Study completion: Jan 2017 (actual)
First posted: 3 Apr 2014 (estimated)
Results: Posted 10 Feb 2021

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 System

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Is a healthy non-smoking (must have quit 6 months prior) male or female between 18 and 65 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
Has unwanted non-cosmetic tattoo containing red ink, that has not previously been treated, and wishes to undergo laser treatment

Key exclusion criteria (13 listed)

The subject is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
The subject is hypersensitive to light exposure OR takes photo sensitized medication.
The subject has active or localized systemic infections.
The subject has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy {greater than 81 mg per day}).
The subject 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 System	Device	Picosure Laser System

Primary outcome

Tattoo Clearance Percentage Using a Photographic Scale
Time frame: 1-3 month follow up post each subject's last treatment, an average of 17.5 months
Clearance will be measured using a clearance aesthetic improvement scale. This scale ranges from 0% to 100%, where 0% is 0% tattoo cleared compared to the baseline tattoo, and 100% is 100% of tattoo cleared compared to the baseline tattoo.

2 secondary outcomes

Investigator Satisfaction
Time frame: Baseline and 2 months post last treatment follow up (+/- 1 month)
Subject Satisfaction
Time frame: Baseline and 2 months post last treatment follow up (+/- 1 month)

Results and safety

Results posted to the registry on 10 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Picosure Laser System	44	27

Primary outcome: Tattoo Clearance Percentage Using a Photographic Scale

Time frame: 1-3 month follow up post each subject's last treatment, an average of 17.5 months. Mean (Standard Deviation). Unit: percentage of clearance

Measure	Picosure Laser System n = 27
Value	84.7 (16.9)

Population analysed: 12 subjects were lost to follow up, and 5 subjects withdrew consent.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events occurring will be captured and followed throughout the patients' participation in the study, approximately 23 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Picosure Laser System- 532 nm Wavelength	0 of 27 (0%)	27 of 27 (100%)	0 of 27
Picosure Laser System- 755 nm Wavelength	0 of 27 (0%)	27 of 27 (100%)	0 of 27
Picosure Laser System- 1064 nm Wavelength	0 of 41 (0%)	41 of 41 (100%)	0 of 41

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
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 13 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 28 Apr 2021. 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 10 Feb 2021). 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?

Tattoo Clearance Percentage Using a Photographic Scale (time frame: 1-3 month follow up post each subject's last treatment, an average of 17.5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02103153.

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 28 Apr 2021.