Evaluation of the 755nm Alexandrite for Unwanted Tattoos

Study Overview
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Brief Summary
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The purpose of this study is to collect further data on the safety and efficacy of removing unwanted non cosmetic tattoos (including recalcitrant) using a 755nm Alexandrite laser.

Conditions
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Unwanted, Non Cosmetic, Tattoos

Intervention / Treatment
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* Device: 755 nm alexandrite laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is a healthy male or female between 18 and 85 years old. Has unwanted non-cosmetic tattoo(s) and wishes to undergo laser treatments to remove them. Is willing to consent to participate in the study. Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits. Exclusion Criteria: Is hypersensitive to light exposure. Has active localized or systemic infection. Is taking medication(s) for which sunlight is a contraindication. Has a history of squamous cell carcinoma or melanoma. Has a history of keloid scarring. Has used oral isotretinoin (Accutane®) within 12 months of initial treatment or plans on using during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment. Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications. Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period. Is allergic to lidocaine, tetracaine or Xylocaine with epinephrine. Has any other reason determined by the physician to be ineligible to participate in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: 755nm Alexandrite Laser Single Pass (Right Side).<br>755nm Alexandrite Laser for Treatment of unwanted, non cosmetic tattoos. The right side will be treated once within the same visit. | Device: 755 nm alexandrite laser<br>* 755 nm alexandrite laser for the treatment of unwanted, non cosmetic, tattoos.<br>|
| Experimental: 755nm Alexandrite Laser Double Pass (Left Side)<br>755nm Alexandrite Laser for Treatment of unwanted, non cosmetic tattoos. The left side of the tattoo will be treated twice within the same visit 20 minutes apart. | Device: 755 nm alexandrite laser<br>* 755 nm alexandrite laser for the treatment of unwanted, non cosmetic, tattoos.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tattoo Clearance | Clearance will be measured using a clearance aesthetic improvement scale. This scale ranges from 0 to 10, where 0 is 0% tattoo cleared compared to the baseline tattoo, and 10 is 100% of tattoo cleared compared to the baseline tattoo. | Post Treatment 1 (6 Weeks Post Baseline) | 
| Tattoo Clearance | Clearance will be measured using a clearance aesthetic improvement scale. This scale ranges from 0 to 10, where 0 is 0% tattoo cleared compared to the baseline tattoo, and 10 is 100% of tattoo cleared compared to the baseline tattoo. | Post Treatment 2 (12 Weeks Post Baseline) | 
| Tattoo Clearance | Clearance will be measured using a clearance aesthetic improvement scale. This scale ranges from 0 to 10, where 0 is 0% tattoo cleared compared to the baseline tattoo, and 10 is 100% of tattoo cleared compared to the baseline tattoo. | Post Treatment 3 (18 Weeks Post Baseline) |