An interventional study of Cutera enlighten laser and CynoSure PicoSure 755nm laser in Tattoo Removal, sponsored by Cutera Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-04.
Sponsored by Cutera Inc. · Not applicable, Interventional, and Treatment
Study to evaluate safety and efficacy of treatment with the investigational Cutera enlighten laser for tattoo removal as compared to treatment with the Cynosure PicoSure laser
This is an open-label, split-tattoo, single-center prospective, comparison study in up to 20 male or female subjects, age 18 to 65 years, who desire laser removal of a tattoo containing single or multi-color ink. Subjects will receive laser treatments, and will be followed at 6 weeks.
Cutera Inc. is the lead sponsor of 42 studies on the registry; none are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 19 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tattoo removal treatments with the investigational Cutera enlighten laser
Device: Cutera enlighten laser
Tattoo removal treatments with the Cynosure PicoSure 755 nm laser
Device: CynoSure PicoSure 755nm laser
high-powered, Q-switched 670nm Picosecond laser system indicated for tattoo removal
Also known as: 670nm Picosecond Laser
high-powered, Q-switched Alexandrite system that delivers laser energy in the 755 nm wavelength and has received FDA clearance (K133364) for tattoo and benign pigmented lesion removal.
Degree of Tattoo Clearing as Assessed by the Investigator (Physician's Global Assessment of Improvement)
Degree of tattoo clearing at 6 weeks post-final treatment as assessed by the Investigator (Physician's Global Assessment of Improvement). Higher scores indicate better outcomes 4= Very Significant or Complete Clearing 3= Significant Clearing 2= Moderate Clearing 1= Mild Clearing 0= No Clearing
Time frame: 6 weeks post-final treatment, an average of 8 months from baseline
| Milestone | Single Arm Treatment - Cutera Enlighten Laser | Split Tattoo Treatment - Cutera Enligthen Laser | Split Tattoo Treatment - Cynosure PicoSure 755 nm Laser |
|---|---|---|---|
| Started | 5 | 5 | 5 |
| Completed | 1 | 1 | 1 |
| Not completed | 4 | 4 | 4 |
Degree of tattoo clearing at 6 weeks post-final treatment as assessed by the Investigator (Physician's Global Assessment of Improvement). Higher scores indicate better outcomes 4= Very Significant or Complete Clearing 3= Significant Clearing 2= Moderate Clearing 1= Mild Clearing 0= No Clearing
| score on a scale | Single Arm Treatment | Split Tattoo Treatment- Enlighten | Split Tattoo Treatment- PicoSure |
|---|---|---|---|
| Degree of Tattoo Clearing as Assessed by the Investigator (Physician's Global Assessment of Improvement) | 4 ± 0 | 4 ± 0 | 4 ± 0 |
Collected over 6 weeks post final treatment, up to 8 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single Arm Treatment - Cutera Enlighten Laser | 0/5 (0%) | 0/5 (0%) | 5/5 (100%) |
| Split Tattoo Treatment - Cutera Enlighten Laser | 0/5 (0%) | 0/5 (0%) | 5/5 (100%) |
| Split Tattoo Treatment - Cynosure PicoSure 755 nm Laser | 0/5 (0%) | 0/5 (0%) | 5/5 (100%) |
| Event | Single Arm Treatment - Cutera Enlighten Laser | Split Tattoo Treatment - Cutera Enlighten Laser | Split Tattoo Treatment - Cynosure PicoSure 755 nm Laser |
|---|---|---|---|
| ErythemaSkin and subcutaneous tissue disorders | 5/5 | 5/5 | 5/5 |
| EdemaSkin and subcutaneous tissue disorders | 4/5 | 5/5 | 5/5 |
| PetechiaeSkin and subcutaneous tissue disorders | 2/5 | 2/5 | 2/5 |
| Age, Categorical(Participants) | Single Arm Treatment | Split Tattoo Treatment | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 5 | 10 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Single Arm Treatment | Split Tattoo Treatment | Total |
|---|---|---|---|
| Female | 3 | 4 | 7 |
| Male | 2 | 1 | 3 |
| Race (NIH/OMB)(Participants) | Single Arm Treatment | Split Tattoo Treatment | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 5 | 5 | 10 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2016 to primary completion in Aug 2017, 11 months.
Results were first posted in Oct 2023, 6 years 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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