Lutronic PicoPlus Exploratory Clinical Trial

This is an interventional treatment trial for Tattoo; Pigmentation Read More

Inclusion Criteria:

• Male or Female
• Adults between age 18 and 60 years old
• Group A: Fitzpatrick skin type I - VI for unwanted tattoos and Group B: Fitzpatrick Skin Types I - IV for benign pigmented lesions and other conditions

• Unwanted tattoo that contains single or multi-color ink, and

  • 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
• Ability to read, understand, and sign the Informed Consent Form
• Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes.
• Understands and accepts the obligation not to undergo any other procedures in the areas to be treated
• Willing and able to comply with all study participation requirements including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study

Exclusion Criteria:

• If receiving treatment for unwanted tattoo: double tattoos (tattoo over tattoo), history of allergic reactions to pigments following tattooing, local anesthetics or topical antibiotics
• If receiving treatment for benign pigmented lesions including melasma: history of use of a lightening medication (hydroquinone, tranexamic acid), isotretinoid (or retinoid), or light-sensitive medication in the last 6 months
• Known cardiovascular disease or cardiac surgery that in the opinion of the investigator would interfere with study treatments
• Previous interventions or treatment with another device in the target area within 6 months of enrollment or during the study
• Pregnant or lactating or planning pregnancy before end of study
• Presence of an active systemic, local skin disease, medication or condition that may affect wound healing or interfere with participation or treatment to the active area.
• Active or recurrent cancer of current chemotherapy or radiation therapy
• History of seizure disorders due to light
• History of vitiligo, eczema, or psoriasis
• History of connective tissue disease, such as systemic lupus erythematosus or scleroderma
• History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation
• 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 keloid scarring, hypertrophic scarring or of abnormal wound healing.
• History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
• History of seizure disorders due to light.
• Suffering from coagulation disorders or taking prescription anticoagulation medications
• History of keloid scarring, hypertrophic scarring or of abnormal wound healing Any use of medication that is known to increase sensitivity to light according to Investigator's discretion
• Excessive or recent significant tan in areas to be treated or unable/unlikely to refrain from tanning during the study
• Current smoker or history of smoking within 3 months of study participation
• Systemic use of corticosteroid or isotretinoin within 6 months of study participation
• Anytime in life, having have used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus
• Any physical or mental condition including alcohol or drug abuse that in the opinion of the investigator could interfere with subject's suitability for inclusion in study