Performance Evaluation of Tattoo Removal

LigthSense

Status

Unknown

Conditions

Tattoo Removal

Treatments

Device: Device: S2 Picosecond laser

Study type

Interventional

Funder types

Industry

Identifiers

NCT03866304

CLN-ST-01-PR

Details and patient eligibility

About

Evaluate safety and efficacy of S2 multi-wavelength laser for tattoo removal

Full description

The purpose of this investigation is to evaluate safety and efficacy of S2 multi-wavelength laser for tattoo removal.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy female and male subjects between 18 to 65 years of age
Fitzpatrick Skin Type I - VI
Have unwanted decorative (non-cosmetic) tattoo(s) and willing to undergo laser treatments to remove them
Have a tattoo contains containing single or multi-color ink.
Willing to receive the proposed S2 laser treatments and comply with study (protocol) requirements
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.
Agree not to undergo any other procedure(s) for the tattoo removal during the study.

Exclusion criteria

Participation in a study of another device or drug within 6 months prior to enrollment or during the study.
Pregnant or planning to become pregnant, having given birth less than 3 months prior to treatment, and/or breastfeeding
History of allergic reaction to pigments following tattooing.
History of hypersensitivity to light exposure
Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
History of malignant tumors in the target area.
Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including, but not limited to, open lacerations or abrasions, hidradenitis, or dermatitis of the treatment area prior to treatment or during the treatment course
Anytime in life, having have used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus.
History of keloid scarring, abnormal wound healing and / or prone bruising
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.
Suffering from Histoplasmosis, hyperparathyroidism, Lymphoma, kidney disease, sarcoidosis, tuberculosis, high levels of calcium in the blood
Suffering from Vitamin D deficiency
As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.