Pilot Study of Multi-wavelength Laser for Tattoo Removal

September 12, 2023 updated by: Cutera Inc.

A Multi-Center Pilot Study of a Novel Multi-Wavelength Laser for Tattoo Removal

To evaluate the safety and efficacy of an investigational version of the Cutera enLighten laser that offers muliple wavelengths for tattoo removal.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Brisbane, California, United States, 94005
        • Cutera Research Center
    • Massachusetts
      • Chestnut Hill, Massachusetts, United States, 02467
        • Skin Care Physicians

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Female or Male, 18 to 65 years of age (inclusive).
  2. Fitzpatrick Skin Type I - VI (Appendix 3).
  3. Target tattoo contains single or multi-color ink.
  4. Subject must be able to read, understand and sign the Informed Consent Form.
  5. Must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
  6. 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.
  7. Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes.
  8. Agree to not undergo any other procedure(s) for tattoo removal during the study (as applicable).

  9. Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study, and no plans to become pregnant for the duration of the study.

    -

Exclusion Criteria:

  1. Participation in a clinical trial of a drug or another device in the target area during the study..
  2. Target tattoo contains only black ink.
  3. History of allergic reaction to pigments following tattooing..
  4. History of allergy to local anesthetics.
  5. History of allergy to topical antibiotics.
  6. History of malignant tumors in the target area.
  7. Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles.
  8. Pregnant and/or breastfeeding.
  9. Having an infection, dermatitis or a rash in the treatment area.
  10. Significant concurrent illness, such as diabetes mellitus or cardiovascular disease, e.g., uncontrolled hypertension.
  11. Suffering from coagulation disorders or taking prescription anticoagulation medications.
  12. History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
  13. History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
  14. History of vitiligo, eczema, or psoriasis.
  15. History of connective tissue disease, such as systemic lupus erythematosus or scleroderma.
  16. History of seizure disorders due to light.
  17. Any use of medication that is known to increase sensitivity to light according to Investigator's discretion.
  18. History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen.
  19. History of radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer.
  20. History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
  21. Systemic use of corticosteroid or isotretinoin within 6 months of study participation.
  22. Anytime in life, having have used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus.
  23. Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
  24. Current smoker or history of smoking within 6 months of study participation.

  25. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: arm-1
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Degree of Tattoo Clearing at 6 Weeks Post-final Treatment as Assessed by the Investigator
Time Frame: 6 weeks post-final treatment
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
6 weeks post-final treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Degree of tattoo clearing at 6 weeks post-final treatment as assessed by the Subject
Time Frame: 6 weeks post-final treatment
Degree of tattoo clearing using the GAIS (Global Assessment of Improvement Scale): 3 = Very Significant Improvement (75 - 100%), 2 = Significant Improvement (50 - 74%), 1 = Moderate Improvement (25 - 49%) or 0 = Mild or No Improvement (0 - 24%)
6 weeks post-final treatment
Degree of Satisfaction at 6 weeks post-final treatment as assessed by the Subject
Time Frame: 6 weeks post-final treatment
Degree of Satisfaction: 2=Extremely Satisfied, 1=Satisfied, 0=Neutral, -1=Unsatisfied or -2=Extremely Unsatisfied
6 weeks post-final treatment
Degree of tattoo clearing at 6 weeks post-final treatment as assessed by Independent blinded reviewers
Time Frame: 6 week post-final treatment
Degree of tattoo clearing using the GAIS (Global Assessment of Improvement Scale): 3 = Very Significant Improvement (75 - 100%), 2 = Significant Improvement (50 - 74%), 1 = Moderate Improvement (25 - 49%) or 0 = Mild or No Improvement (0 - 24%)
6 week post-final treatment

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence and Severity of device related Adverse Events of Cutera enLighten
Time Frame: through study completion, an average of 5 years
Incidence of treatment-emergent Adverse Events
through study completion, an average of 5 years
Subject Pain Levels
Time Frame: through study completion, an average of 5 years
Mosby Pain Rating Scale as rated by Subject both during, and 5-10 minutes after treatment: Mosby Scale:0=No Pain to 10=Worst Pain
through study completion, an average of 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cutera Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jeffrey Dover, M.D., Skin Care Physicians
  • Principal Investigator: Stephen Ronan, M.D., Cutera Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 8, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 29, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 29, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C-15-EN10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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