Unwanted, Non Cosmetic, TattoosNCT01842815
Evaluation of the 755nm Alexandrite for Unwanted Tattoos
A study testing 755 nm alexandrite laser in people with Unwanted, Non Cosmetic, Tattoos, run by Cynosure, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to collect further data on the safety and efficacy of removing unwanted non cosmetic tattoos (including recalcitrant) using a 755nm Alexandrite laser. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Unwanted, Non Cosmetic, Tattoos
- What is being tested?
- 755 nm alexandrite laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Dec 2015
- 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.
- Has unwanted non-cosmetic tattoo(s) and wishes to undergo laser treatments to remove them.
- 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.
Who cannot join
- Is hypersensitive to light exposure.
- Has active localized or systemic infection.
- Is taking medication(s) for which sunlight is a contraindication.
- Has a history of squamous cell carcinoma or melanoma.
- Has a history of keloid scarring.
- Has used oral isotretinoin (Accutane®) within 12 months of initial treatment or plans on using during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment.
Show all 10Show fewer
- Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
- 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 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
Laser & Skin Surgery Center of Northern California
Sacramento, California, 95816
About this study
The purpose of this study is to collect further data on the safety and efficacy of removing unwanted non cosmetic tattoos (including recalcitrant) using a 755nm Alexandrite laser.
- Conditions
- Unwanted, Non Cosmetic, Tattoos
- Being tested
- 755 nm alexandrite laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
755 nm alexandrite laserDevice
755 nm alexandrite laser for the treatment of unwanted, non cosmetic, tattoos.
| Study group | Role | What they receive |
|---|---|---|
| 755nm Alexandrite Laser Single Pass (Right Side). | Experimental | 755nm Alexandrite Laser for Treatment of unwanted, non cosmetic tattoos. The right side will be treated once within the same visit. Receives: Device: 755 nm alexandrite laser |
| 755nm Alexandrite Laser Double Pass (Left Side) | Experimental | 755nm Alexandrite Laser for Treatment of unwanted, non cosmetic tattoos. The left side of the tattoo will be treated twice within the same visit 20 minutes apart. Receives: Device: 755 nm alexandrite laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tattoo Clearance
Clearance will be measured using a clearance aesthetic improvement scale. This scale ranges from 0 to 10, where 0 is 0% tattoo cleared compared to the baseline tattoo, and 10 is 100% of tattoo cleared compared to the baseline tattoo.
Measured: Post Treatment 1 (6 Weeks Post Baseline)
Tattoo Clearance
Clearance will be measured using a clearance aesthetic improvement scale. This scale ranges from 0 to 10, where 0 is 0% tattoo cleared compared to the baseline tattoo, and 10 is 100% of tattoo cleared compared to the baseline tattoo.
Measured: Post Treatment 2 (12 Weeks Post Baseline)
Tattoo Clearance
Clearance will be measured using a clearance aesthetic improvement scale. This scale ranges from 0 to 10, where 0 is 0% tattoo cleared compared to the baseline tattoo, and 10 is 100% of tattoo cleared compared to the baseline tattoo.
Measured: Post Treatment 3 (18 Weeks Post Baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2015
- Study completionDec 2015
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, Non Cosmetic, 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT01842815
- Sponsor's protocol ID
- CYN13-PICO-SK
- Status last verified
- Dec 2020
- First submitted
- 26 Apr 2013
- Last updated
- 5 Jan 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 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the 755nm Alexandrite for Unwanted Tattoos
- ClinicalTrials.gov ID
- NCT01842815
- Acronym / sponsor ID
- CYN13-PICO-SK
- Conditions
- Unwanted, Non Cosmetic, Tattoos
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cynosure, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 30 Apr 2013 (estimated)
- Results
- Posted 5 Jan 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 collect further data on the safety and efficacy of removing unwanted non cosmetic tattoos (including recalcitrant) using a 755nm Alexandrite laser.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 755nm Alexandrite Laser Single Pass (Right Side). | Experimental | Device: 755 nm alexandrite laser755nm Alexandrite Laser for Treatment of unwanted, non cosmetic tattoos. The right side will be treated once within the same visit. |
| 755nm Alexandrite Laser Double Pass (Left Side) | Experimental | Device: 755 nm alexandrite laser755nm Alexandrite Laser for Treatment of unwanted, non cosmetic tattoos. The left side of the tattoo will be treated twice within the same visit 20 minutes apart. |
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.
- Has unwanted non-cosmetic tattoo(s) and wishes to undergo laser treatments to remove them.
- 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.
Key exclusion criteria (10 listed)
- Is hypersensitive to light exposure.
- Has active localized or systemic infection.
- Is taking medication(s) for which sunlight is a contraindication.
- Has a history of squamous cell carcinoma or melanoma.
- Has a history of keloid scarring.
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 |
|---|---|---|
| 755 nm alexandrite laser755 nm alexandrite laser for the treatment of unwanted, non cosmetic, tattoos. | Device | 755nm Alexandrite Laser Double Pass (Left Side), 755nm Alexandrite Laser Single Pass (Right Side). |
Primary outcome
Tattoo Clearance
Time frame: Post Treatment 1 (6 Weeks Post Baseline)
Clearance will be measured using a clearance aesthetic improvement scale. This scale ranges from 0 to 10, where 0 is 0% tattoo cleared compared to the baseline tattoo, and 10 is 100% of tattoo cleared compared to the baseline tattoo.
Tattoo Clearance
Time frame: Post Treatment 2 (12 Weeks Post Baseline)
Clearance will be measured using a clearance aesthetic improvement scale. This scale ranges from 0 to 10, where 0 is 0% tattoo cleared compared to the baseline tattoo, and 10 is 100% of tattoo cleared compared to the baseline tattoo.
Tattoo Clearance
Time frame: Post Treatment 3 (18 Weeks Post Baseline)
Clearance will be measured using a clearance aesthetic improvement scale. This scale ranges from 0 to 10, where 0 is 0% tattoo cleared compared to the baseline tattoo, and 10 is 100% of tattoo cleared compared to the baseline tattoo.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 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 755 nm alexandrite laser in people with Unwanted, Non Cosmetic, 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 10 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 5 Jan 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 5 Jan 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 (time frame: Post Treatment 1 (6 Weeks Post Baseline)). The study lists 3 primary outcomes in all. 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 Jan 2021.