Pilot Study of Multi-wavelength Laser for Tattoo Removal

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: Completed
• Conditions: Tattoo Removal
• Intervention / Treatment: Device: Cutera enLighten laser

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: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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.

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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.

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Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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	6 weeks post-final treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of tattoo clearing at 6 weeks post-final treatment as assessed by the Subject	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	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	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

Outcome Measure	Measure Description	Time Frame
Incidence and Severity of device related Adverse Events of Cutera enLighten	Incidence of treatment-emergent Adverse Events	through study completion, an average of 5 years
Subject Pain Levels	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

• Sponsor: Cutera Inc.
• Investigators: Principal Investigator: Jeffrey Dover, M.D., Skin Care Physicians; Principal Investigator: Stephen Ronan, M.D., Cutera Research Center

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2015
• Primary Completion (Actual): November 29, 2017
• Study Completion (Actual): November 29, 2017

Study Registration Dates

• First Submitted: September 19, 2017
• First Submitted That Met QC Criteria: September 20, 2017
• First Posted (Actual): September 25, 2017

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID 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