Laser Tattoo RemovalNCT02431104
Clinical Evaluation of Tattoo Removal Using a Novel Dual-Wavelength, Dual-Pulse Duration Laser
A study testing 532-nm KTP/1064-nm Nd:YAG Dual-Pulse Duration Laser in people with Laser Tattoo Removal, run by Cutera Inc. at 1 site in Canada.
Trial summary
A single-center prospective, open-label, uncontrolled study in 10 male or female subjects, age 18 to 65 years, who desire laser removal of a tattoo which contains all black ink. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Laser Tattoo Removal
- What is being tested?
- 532-nm KTP/1064-nm Nd:YAG Dual-Pulse Duration Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2015to 22 Feb 2016
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fitzpatrick Skin Type I - VI
- Target tattoo contains only black ink, is more than 1 year old and must have been obtained from a professional tattoo parlor.
- Wiling to cover tattoos with a bandage or clothing; and/or have very limited sun exposure and use an approved sunscreen of SPF 50 or higher on the treated area starting 2 to 4 weeks before the treatment and/or every day for the duration of the study, including the follow-up period.
Who cannot join
- Target tattoo is 'home made' OR was obtained from an amateur artist.
- Presence of double tattoo in the treatment area or presence of tribal, scarred, high-ink density, or highly colorful single tattoo.
- Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study.
- History of allergic reaction to pigments following tattooing.
- History of allergy to local anesthetics.
- History of malignant tumors in the target area.
Show all 9Show fewer
- History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
- Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
- Current smoker or history of smoking within 6 months of study participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Tattoo Removal Using a Novel Dual-Wavelength, Dual-Pulse Duration Laser"
A single-center prospective, open-label, uncontrolled study in 10 male or female subjects, age 18 to 65 years, who desire laser removal of a tattoo which contains all black ink.
Read the detailed description
This is a single-center prospective, open-label, uncontrolled study in 10 male or female subjects, age 18 to 65 years, who desire laser removal of a tattoo which contains all black ink. Subjects will receive up to 5 laser treatments, spaced 4 to 6 weeks apart, and will be followed at 3 months post-final treatment. Number of laser treatments required shall be based upon tattoo response to laser irradiation. The Investigator will terminate laser treatments upon 100% clearance of tattoo or after 5 treatment sessions, or in the event of an adverse effect which requires cessation of laser treatment.
- Conditions
- Laser Tattoo Removal
- Being tested
- 532-nm KTP/1064-nm Nd:YAG Dual-Pulse Duration Laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
532-nm KTP/1064-nm Nd:YAG Dual-Pulse Duration LaserDevice
Also called Enlighten laser
Cutera enlighten dual wavelength 532nm KTP/1064nm Nd:YAG laser
| Study group | Role | What they receive |
|---|---|---|
| Laser Treatment | Experimental | Treatment to unwanted tattoo using a 532-nm KTP/1064-nm Nd:YAG Dual-Pulse Duration Laser Receives: Device: 532-nm KTP/1064-nm Nd:YAG Dual-Pulse Duration Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician's Global Assessment of improvement post-final treatment
Assessment of tattoo clearance by independent blinded reviewers
Measured: 3 months
Secondary outcomes (3)
Subject's Global Assessment of improvement post-final treatment
Assessment of tattoo clearance by subject
Measured: 3 months
Subject Satisfaction post-final treatment
Assessment of subject satisfaction with treatment results.
Measured: 3 months
Incidence and severity of adverse device effects
Assessment of ADEs immediately following each laser treatment and at the final follow-up visit.
Measured: Day 0, 4 wks, 8wks, 12 wks, 16 wks, 28 wks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionFeb 2016
- Study completion22 Feb 2016
Why it stopped: Sponsor terminated study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laser Tattoo RemovalStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cutera Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sheetal Sapra, MD, Principal investigator, ICLS Dermatology and Plastic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02431104
- Sponsor's protocol ID
- C-15-EN02
- Status last verified
- Jan 2023
- First submitted
- 27 Apr 2015
- Last updated
- 27 Jan 2023
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Tattoo Removal Using a Novel Dual-Wavelength, Dual-Pulse Duration Laser"
- ClinicalTrials.gov ID
- NCT02431104
- Acronym / sponsor ID
- C-15-EN02
- Conditions
- Laser Tattoo Removal
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor terminated study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cutera Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- 22 Feb 2016 (actual)
- First posted
- 30 Apr 2015 (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.
A single-center prospective, open-label, uncontrolled study in 10 male or female subjects, age 18 to 65 years, who desire laser removal of a tattoo which contains all black ink.
Detailed description
This is a single-center prospective, open-label, uncontrolled study in 10 male or female subjects, age 18 to 65 years, who desire laser removal of a tattoo which contains all black ink. Subjects will receive up to 5 laser treatments, spaced 4 to 6 weeks apart, and will be followed at 3 months post-final treatment. Number of laser treatments required shall be based upon tattoo response to laser irradiation. The Investigator will terminate laser treatments upon 100% clearance of tattoo or after 5 treatment sessions, or in the event of an adverse effect which requires cessation of laser treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laser Treatment | Experimental | Device: 532-nm KTP/1064-nm Nd:YAG Dual-Pulse Duration LaserTreatment to unwanted tattoo using a 532-nm KTP/1064-nm Nd:YAG Dual-Pulse Duration Laser |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Fitzpatrick Skin Type I - VI
- Target tattoo contains only black ink, is more than 1 year old and must have been obtained from a professional tattoo parlor.
- Wiling to cover tattoos with a bandage or clothing; and/or have very limited sun exposure and use an approved sunscreen of SPF 50 or higher on the treated area starting 2 to 4 weeks before the treatment and/or every day for the duration of the study, including the follow-up period.
Key exclusion criteria (9 listed)
- Target tattoo is 'home made' OR was obtained from an amateur artist.
- Presence of double tattoo in the treatment area or presence of tribal, scarred, high-ink density, or highly colorful single tattoo.
- Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study.
- History of allergic reaction to pigments following tattooing.
- History of allergy to local anesthetics.
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 |
|---|---|---|
| 532-nm KTP/1064-nm Nd:YAG Dual-Pulse Duration LaserAlso: Enlighten laserCutera enlighten dual wavelength 532nm KTP/1064nm Nd:YAG laser | Device | Laser Treatment |
Primary outcome
Physician's Global Assessment of improvement post-final treatment
Time frame: 3 months
Assessment of tattoo clearance by independent blinded reviewers
3 secondary outcomes
Subject's Global Assessment of improvement post-final treatment
Time frame: 3 months
Subject Satisfaction post-final treatment
Time frame: 3 months
Incidence and severity of adverse device effects
Time frame: Day 0, 4 wks, 8wks, 12 wks, 16 wks, 28 wks
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 27 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Laser Tattoo Removal
Not yet recruiting
Evaluation of Automated Laser-Assisted Tattoo Removal: a Prospective Feasibility Clinical Study
Persons Seeking Tattoo Removal
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.
Sheetal Sapra, MD principal investigator
ICLS Dermatology and Plastic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 532-nm KTP/1064-nm Nd:YAG Dual-Pulse Duration Laser in people with Laser Tattoo Removal, run by Cutera Inc. at 1 site in Canada.
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 3 inclusion and 9 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 27 Jan 2023. 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 Canada. 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?
Physician's Global Assessment of improvement post-final treatment (time frame: 3 months). 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 27 Jan 2023.