Study of Picosecond and Nanosecond Q-switched Lasers for Tattoo Removal

Study Overview
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Brief Summary
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The purpose of this study is to compare the investigational medical grade laser device to a marketed medical grade laser device for effectiveness in lightening or clearing unwanted tattoos. This study will also compare any side effects from treatment with the devices.

Detailed Description
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This is a two center study to evaluate the Cutera RF system. Subjects will be treated on the abdomen and / or flanks areas and / or saddle bag (upper lateral thigh, lateral hip and lower buttocks). The objective of this study is to evaluate the thermal and histological changes observed in the subcutaneous tissue following RF exposure.

Official Title
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Randomized, Split-tattoo Study Comparing Safety and Efficacy of Picosecond and Nanosecond Q-switched Nd:YAG Lasers for Tattoo Removal

Conditions
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Tattoo Removal

Intervention / Treatment
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* Device: Picosecond Q-switched Laser Treatment
* Device: Nanosecond Q-switched Laser Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females or Males, 18 to 65 years of age (inclusive) Fitzpatrick Skin Type I - IV (Appendix 3) Tattoos containing black/blue ink alone or in combination with other colors Target tattoos older than 1 year Presence of tattoos equal or greater than 2 square inches, not to exceed 12 square inches 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 use hydroquinone approximately 4 weeks pre-treatment and post- treatment if required Willingness to have digital photographs taken of the treated area Agree not to undergo any other procedure(s) for the tattoo removal during the study 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 Exclusion Criteria: Participation in a study of another device or drug within 6 months prior to enrollment or during the study Prior treatment for tattoo removal in the target area, e.g., with q-switched laser, IPL, dermabrasion, electrocautery, cryotherapy History of allergic reaction to pigments following tattooing Presence of double tattoo in the treatment area 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, such as tetracycline History of herpes simplex and/or herpes zoster (shingles) 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 within 12 months of study participation Use of oral isotretinoin within 12 months of study participation and topical use of isotretinoin within 6 months on the treated area 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Picosecond Q-switched Laser Treatment<br>Picosecond Q-switched Nd:YAG (1064 nm and 532 nm) laser | Device: Picosecond Q-switched Laser Treatment<br> <br> |
| Active Comparator: Nanosecond Q-switched Laser Treatment<br>Nanosecond Q-switched Nd:YAG (1064 nm and 532 nm) laser | Device: Nanosecond Q-switched Laser Treatment<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tattoo Clearing at 6 Weeks Post-final Laser Treatment for Each Treatment Arm as Assessed by Blinded Reviewers. | Physician's Global Assessment Scale: 0 (min) - 4 (max) Higher scores represent better tattoo clearing 4 = Very Significant Clearing (> 75%) 3 = Significant Clearing (51 - 75%) 2 = Moderate Clearing (26 - 50%) 1 = Mild Clearing (5 - 25%) 0 = No Change (< 5%) | 6-weeks post-final treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Subject Discomfort (Pain) Between Treatment and Active Control Treatment Arms During Treatment | Numeric Pain Rating Scale (Min=0; Max=10) Higher scores mean worse outcome | During treatment, approximately 10 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tattoo Removal, Q-switched laser, Nd:YAG laser, Nanosecond laser, Picosecond laser, Laser therapy, Tattoo, pulsed-laser, laser treatment, remove tattoo, tattoo clearing, tattoo lightening, tattoo lighten