Status:
UNKNOWN
Performance Evaluation of Tattoo Removal
Lead Sponsor:
LigthSense Israel Ltd
Conditions:
Tattoo Removal
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Evaluate safety and efficacy of S2 multi-wavelength laser for tattoo removal
Detailed Description
The purpose of this investigation is to evaluate safety and efficacy of S2 multi-wavelength laser for tattoo removal.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03866304
Start Date
January 21 2019
End Date
August 31 2019
Last Update
March 7 2019
Active Locations (1)
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1
Santara KTC (clinical trial site)
Vilnius, Lithuania, 08406