Split-tattoo Study Comparing the Safety and Efficacy of 670nm Picosecond Laser Versus 755 nm for Tattoo Removal

Study Overview
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Brief Summary
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Study to evaluate safety and efficacy of treatment with the investigational Cutera enlighten laser for tattoo removal as compared to treatment with the Cynosure PicoSure laser

Detailed Description
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This is an open-label, split-tattoo, single-center prospective, comparison study in up to 20 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.

Official Title
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An Open Label, Split-tattoo Study Comparing the Safety and Efficacy of the 670nm Picosecond Laser Versus the 755 nm Picosecond Laser for Tattoo Removal

Conditions
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Tattoo Removal

Intervention / Treatment
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* Device: Cutera enlighten laser
* Device: CynoSure PicoSure 755nm laser


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational Enlighten Device<br>Tattoo removal treatments with the investigational Cutera enlighten laser | Device: Cutera enlighten laser<br>* high-powered, Q-switched 670nm Picosecond laser system indicated for tattoo removal<br>* Other names: 670nm Picosecond Laser;|
| Active Comparator: Cynosure PicoSure 755 nm laser<br>Tattoo removal treatments with the Cynosure PicoSure 755 nm laser | Device: CynoSure PicoSure 755nm laser<br>* high-powered, Q-switched Alexandrite system that delivers laser energy in the 755 nm wavelength and has received FDA clearance (K133364) for tattoo and benign pigmented lesion removal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of Tattoo Clearing as Assessed by the Investigator (Physician's Global Assessment of Improvement) | Degree of tattoo clearing at 6 weeks post-final treatment as assessed by the Investigator (Physician's Global Assessment of Improvement). Higher scores indicate better outcomes 4= Very Significant or Complete Clearing 3= Significant Clearing 2= Moderate Clearing 1= Mild Clearing 0= No Clearing | 6 weeks post-final treatment, an average of 8 months from baseline |