Clinical trial NCT03866304: Performance Evaluation of Tattoo Removal
Official title: A Single-center, Open-label, Uncontrolled Pilot Study to Evaluate the Safety and Efficacy of S2 - Multi-Wavelength Laser for Tattoo Removal
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tattoo Removal
Lead sponsor: LigthSense Israel Ltd
Sponsor class: INDUSTRY
First posted: 2019-03-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Tattoo clearing
timeFrame: 8 weeks post-final treatment (up to 6 month)
Secondary outcomes:
measure: Degree of tattoo clearing as assessed by PGA
timeFrame: 8 weeks post-final treatment (up to 6 month)
measure: Degree of tattoo clearing at 8 weeks post-final treatment as assessed by Subject
timeFrame: 8 weeks post-final treatment (up to 6 month)
measure: Subject discomfort (pain) during treatments
timeFrame: During the treatments period (up to 6 month)
measure: Subject satisfaction Questionnaire (4-8 weeks post-final treatment)
timeFrame: 4-8 weeks post-final treatment (up to 6 month)
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: Santara KTC (clinical trial site)
Study officials:
affiliation: Santara KTC
name: Ruta Ganceviciene,, Dr
role: PRINCIPAL_INVESTIGATOR
References: