Multi-Wavelength Laser Tattoo Removal Pivotal Study

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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A Prospective, Multi-Center Pivotal Clinical Evaluation of a Novel Multi-Wavelength Laser for Tattoo Removal

Conditions
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Tattoo Removal

Intervention / Treatment
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* Device: enLighten 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, and must include blue and/or green ink. Target tattoos must be older than 1 year. Target treatment area not to exceed 12 square inches. 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 per investigator's discretion. 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, as applicable, within 6 months of study participation. Anytime in life, having 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Treatment with investigational Cutera enlighten laser for tattoo removal | Device: enLighten Laser<br>* Laser tattoo removal treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 weeks post-final treatment, approximately 7 months after study start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 weeks post-final treatment, approximately 7 months after study start | 
| Subject Satisfaction Levels at 6 Weeks Post-final Treatment |  | 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. | Reported by subject at the end of each treatment visit, up to 5 months |