An interventional study of 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 2023-09-26.
Sponsored by Cutera Inc. · Not applicable, Interventional, and Treatment
Multi-center study to evaluate the safety and efficacy of an investigational version of the Cutera enlighten laser that offers multiple wavelengths for tattoo removal
A multi-center prospective, open-label, uncontrolled pivotal study to evaluate the safety and efficacy of an investigational version of the Cutera enlighten laser that offers multiple wavelengths for tattoo removal.
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.
Treatment with investigational Cutera enlighten laser for tattoo removal
Device: enLighten Laser
Laser tattoo removal treatment
Tattoo Clearing as Rated by Blinded Evaluator
Percentage of subjects with tattoo ink clearing of at least 50% or more at 6 weeks post-final treatment
Time frame: 6 weeks post-final treatment, approximately 7 months after study start
Degree of Overall Tattoo Ink Clearing at 6 Weeks Post-final Treatment as Assessed by the Investigator (Physician's Global Assessment of Improvement).
Physician's Global Assessment of Improvement (min=0; max=4) Higher scores mean better outcomes
Time frame: 6 weeks post-final treatment, approximately 7 months after study start
Subject Satisfaction Levels at 6 Weeks Post-final Treatment
Time frame: 6 weeks post-final treatment, approximately 7 months after study start
Subject Pain During Treatment
Numeric Pain Rating Scale (Min=0; Max=10) Higher scores indicate worse outcomes Pain values from all treatment visits and subjects were combined and averaged.
Time frame: Reported by subject at the end of each treatment visit, up to 5 months
| Milestone | Treatment |
|---|---|
| Started | 27 |
| Completed | 25 |
| Not completed | 2 |
Percentage of subjects with tattoo ink clearing of at least 50% or more at 6 weeks post-final treatment
| Participants | Treatment |
|---|---|
| Tattoo Clearing as Rated by Blinded Evaluator | 21 |
Physician's Global Assessment of Improvement (min=0; max=4) Higher scores mean better outcomes
| score on a scale | Treatment |
|---|---|
| Degree of Overall Tattoo Ink Clearing at 6 Weeks Post-final Treatment as Assessed by the Investigator (Physician's Global Assessment of Improvement). | 3.43 ± 0.7 |
| Participants | Treatment |
|---|---|
| number of subjects reporting they were "extremely satisfied" or "satisfied" with level of clearing | 9 |
| number of subjects reporting they were neutral with level of clearing | 4 |
| number of subjects who said they would the investigational treatment again | 11 |
Numeric Pain Rating Scale (Min=0; Max=10) Higher scores indicate worse outcomes Pain values from all treatment visits and subjects were combined and averaged.
| score on a scale | Treatment |
|---|---|
| Subject Pain During Treatment | 4.2 ± 2.9 |
Collected over Adverse event data were collected 6 weeks post final laser treatment, up to an average of 7 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment | 0/27 (0%) | 0/27 (0%) | 27/27 (100%) |
| Event | Treatment |
|---|---|
| ErythemaSkin and subcutaneous tissue disorders | 27/27 |
| EdemaSkin and subcutaneous tissue disorders | 27/27 |
| FrostingSkin and subcutaneous tissue disorders | 27/27 |
| CrustingSkin and subcutaneous tissue disorders | 13/27 |
| Age, Continuous(years) | Treatment |
|---|---|
| Mean | 38.7 (24 to 61) |
| Sex: Female, Male(Participants) | Treatment |
|---|---|
| Female | 18 |
| Male | 9 |
| Ethnicity (NIH/OMB)(Participants) | Treatment |
|---|---|
| Hispanic or Latino | 5 |
| Not Hispanic or Latino | 22 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Treatment |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 3 |
| Native Hawaiian or Other Pacific Islander | 2 |
| Black or African American | 1 |
| White | 21 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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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