Clinical Evaluation of Tattoo Removal Using a Novel Dual-Wavelength, Dual-Pulse Duration Laser

Study Overview
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Brief Summary
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A single-center prospective, open-label, uncontrolled study in 10 male or female subjects, age 18 to 65 years, who desire laser removal of a tattoo which contains all black ink.

Detailed Description
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This is a single-center prospective, open-label, uncontrolled study in 10 male or female subjects, age 18 to 65 years, who desire laser removal of a tattoo which contains all black ink. Subjects will receive up to 5 laser treatments, spaced 4 to 6 weeks apart, and will be followed at 3 months post-final treatment. Number of laser treatments required shall be based upon tattoo response to laser irradiation. The Investigator will terminate laser treatments upon 100% clearance of tattoo or after 5 treatment sessions, or in the event of an adverse effect which requires cessation of laser treatment.

Official Title
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Clinical Evaluation of Tattoo Removal Using a Novel Dual-Wavelength, Dual-Pulse Duration Laser

Conditions
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Laser Tattoo Removal

Intervention / Treatment
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* Device: 532-nm KTP/1064-nm Nd:YAG Dual-Pulse Duration Laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fitzpatrick Skin Type I - VI Target tattoo contains only black ink, is more than 1 year old and must have been obtained from a professional tattoo parlor. 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. Exclusion Criteria: Target tattoo is 'home made' OR was obtained from an amateur artist. Presence of double tattoo in the treatment area or presence of tribal, scarred, high-ink density, or highly colorful single tattoo. Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study. History of allergic reaction to pigments following tattooing. History of allergy to local anesthetics. History of malignant tumors in the target area. History of keloid scarring, hypertrophic scarring or of abnormal wound healing. 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.

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: Laser Treatment<br>Treatment to unwanted tattoo using a 532-nm KTP/1064-nm Nd:YAG Dual-Pulse Duration Laser | Device: 532-nm KTP/1064-nm Nd:YAG Dual-Pulse Duration Laser<br>* Cutera enlighten dual wavelength 532nm KTP/1064nm Nd:YAG laser<br>* Other names: Enlighten laser;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician's Global Assessment of improvement post-final treatment | Assessment of tattoo clearance by independent blinded reviewers | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject's Global Assessment of improvement post-final treatment | Assessment of tattoo clearance by subject | 3 months | 
| Subject Satisfaction post-final treatment | Assessment of subject satisfaction with treatment results. | 3 months | 
| Incidence and severity of adverse device effects | Assessment of ADEs immediately following each laser treatment and at the final follow-up visit. | Day 0, 4 wks, 8wks, 12 wks, 16 wks, 28 wks |