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

Single center study to evaluate the safety and efficacy of an investigational version of the Cutera enlightenTM laser that offers multiple wavelengths for tattoo removal.

Study Overview

• Status: Completed
• Conditions: Tattoo Removal
• Intervention / Treatment: Device: enLighten Laser

Detailed Description

A single-center prospective, open-label, uncontrolled pilot study to evaluate the safety and efficacy of an investigational version of the Cutera enlightenTM laser that offers multiple wavelengths for tattoo removal.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Stamford, Connecticut, United States, 06905
      • Connecticut Skin Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

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

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
Experimental: Treatment; Treatment with investigational Cutera enlighten laser for tattoo removal	Device: enLighten Laser; Laser for tattoo removal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tattoo Clearing as Rated by Investigator	Degree of tattoo clearing at 6 weeks post-final treatment as assessed by the Investigator (Physician's Global Assessment of Improvement). 4= Very Significant or Complete Clearing 3= Significant Clearing 2= Moderate Clearing 1= Mild Clearing 0= No Clearing Higher scores indicate better outcomes	6 weeks post-final treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tattoo clearing as rated by Subject	Degree of tattoo clearing at 6 weeks post-final treatment as assessed by the subject (Subject's Global Assessment of Improvement).	6 weeks post-final treatment
Subject satisfaction Questionnaire	Subject satisfaction levels at 6 weeks post-final treatment using Subject Satisfaction Assessment Scale.	6 weeks post-final treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tattoo clearing as rated by Blinded Evaluator	Degree of tattoo clearing at 6 weeks post-final treatment as assessed by independent blinded reviewers (Global Assessment of Improvement).	6 weeks post-final treatment
Adverse Device Effects	Number and severity of adverse device effects during the study period	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Cutera Inc.
• Investigators: Principal Investigator: Omar Ibrahimi, MD, Connecticut Skin Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): June 28, 2017
• Study Completion (Actual): July 28, 2017

Study Registration Dates

• First Submitted: September 16, 2016
• First Submitted That Met QC Criteria: September 20, 2016
• First Posted (Estimated): September 22, 2016

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: C-16-EN14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO