An interventional study of Cutera enLighten laser in Tattoo Removal, sponsored by Cutera Inc.. Completed at 2 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-15.
Sponsored by Cutera Inc. · Not applicable, Interventional, and Treatment
To evaluate the safety and efficacy of an investigational version of the Cutera enLighten laser that offers muliple wavelengths for tattoo removal.
Currently, the enLighten laser offers two wavelengths: 532nm and 1064nm. The version of the laser under investigation allows the user to choose a wavelength between 640nm to 800nm.
This is a multi-center prospective, open-label, uncontrolled pilot study in up to 75 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.
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Exclusion Criteria:
As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
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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.
Cutera enLighten laser treatments that allows the user to choose a wavelength between 640nm to 800nm.
Device: Cutera enLighten laser
Subjects will receive laser treatments.
Degree of Tattoo Clearing at 6 Weeks Post-final Treatment as Assessed by the Investigator
Degree of tattoo clearing using the GAIS (Global Assessment of Improvement Scale) 3 = Very Significant Improvement, 2 = Significant Improvement, 1 = Moderate Improvement, or 0 = Mild or No Improvement Higher scores indicate better outcomes
Time frame: 6 weeks post-final treatment
| Milestone | Cutera enLighten Laser |
|---|---|
| Started | 22 |
| Completed | 6 |
| Not completed | 16 |
Degree of tattoo clearing using the GAIS (Global Assessment of Improvement Scale) 3 = Very Significant Improvement, 2 = Significant Improvement, 1 = Moderate Improvement, or 0 = Mild or No Improvement Higher scores indicate better outcomes
| score on a scale | Cutera enLighten Laser |
|---|---|
| Degree of Tattoo Clearing at 6 Weeks Post-final Treatment as Assessed by the Investigator | 2 ± 0.9 |
Collected over 12 weeks post final treatment, up to 15 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Enrolled Subjects | 0/22 (0%) | 0/22 (0%) | 22/22 (100%) |
| Event | All Enrolled Subjects |
|---|---|
| EdemaSkin and subcutaneous tissue disorders | 22/22 |
| ErythemaSkin and subcutaneous tissue disorders | 21/22 |
| FrostingSkin and subcutaneous tissue disorders | 20/22 |
| Age, Categorical(Participants) | All Enrolled Subjects |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 22 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | All Enrolled Subjects |
|---|---|
| Female | 17 |
| Male | 5 |
| Race and Ethnicity Not Collected(Participants) | All Enrolled Subjects |
|---|
Plan to share: No
Ran from Jul 2015 to primary completion in Nov 2017, 28 months.
Results were first posted in Sep 2023, 5 years 9 months 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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