Performance Evaluation of Tattoo Removal

NCT ID: NCT03866304

Last Updated: 2019-03-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-21
• Study Completion Date: 2019-08-31

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.

Conditions

Tattoo Removal

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Picosecond Laser

Treatment with investigational wavelengths of the S2 laser for tattoo removal.

Group Type: EXPERIMENTAL

Device: S2 Picosecond laser

Intervention Type: DEVICE

Each subject will receive up to 16 laser treatments.

Interventions

Device: S2 Picosecond laser

Each subject will receive up to 16 laser treatments.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

LigthSense Israel Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ruta Ganceviciene,, Dr

Role: PRINCIPAL_INVESTIGATOR

Santara KTC

Locations

Santara KTC (clinical trial site)

Vilnius, , Lithuania

Site Status: RECRUITING

Countries

Lithuania

Central Contacts

Linas Leikis, Dr

Role: CONTACT

linas.liekis@inlita.lt

(+370) 612 25255

Facility Contacts

Linas Leikis, Dr

Role: primary

linas.liekis@inlita.lt

(+370) 612 25255

Other Identifiers

CLN-ST-01-PR

Identifier Type: -

Identifier Source: org_study_id