| Eligibility |
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
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