Performance Evaluation of Tattoo Removal

A Single-center, Open-label, Uncontrolled Pilot Study to Evaluate the Safety and Efficacy of S2 - Multi-Wavelength Laser for Tattoo Removal

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

Study Overview

• Status: Unknown
• Conditions: Tattoo Removal
• Intervention / Treatment: Device: Device: S2 Picosecond laser

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Linas Leikis, Dr; Phone Number: (+370) 612 25255; Email: linas.liekis@inlita.lt

Study Locations

• Lithuania
  • Vilnius, Lithuania, 08406
    • Recruiting
    • Santara KTC (clinical trial site)
    • Contact: Linas Leikis, Dr; Phone Number: (+370) 612 25255; Email: linas.liekis@inlita.lt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Picosecond Laser; Treatment with investigational wavelengths of the S2 laser for tattoo removal.	Device: Device: S2 Picosecond laser; Each subject will receive up to 16 laser treatments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tattoo clearing	Tattoo clearing as rated by blinded reviewers at 8 weeks post-final treatment (Physician's Global Assessment of Improvement). Blinded reviewer will first be asked to determine the temporal order (before and after) of each photograph pair for each treatment side and then rate the degree of tattoo clearing observed in the after photograph (compared to before photograph) using the Physician's Global Assessment scale: 4 = Very Significant Clearing (> 75%) 3 = Significant Clearing (51 - 75%) 2 = Moderate Clearing (26 - 50%) 1 = Mild Clearing (5 - 25%) 0 = No Change (< 5%)	8 weeks post-final treatment (up to 6 month)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of tattoo clearing as assessed by PGA	Degree of tattoo clearing at 8 weeks post-final treatment as assessed by the Investigators (Physician's Global Assessment of Improvement). The investigator or designee will rate the degree of tattoo clearing observed for each treatment side (compared to baseline) using the same 0-4 scale.	8 weeks post-final treatment (up to 6 month)
Degree of tattoo clearing at 8 weeks post-final treatment as assessed by Subject	8 weeks post the last treatment, subjects will be provided with a short questionnaire to rate the level of tattoo clearing themselves.	8 weeks post-final treatment (up to 6 month)
Subject discomfort (pain) during treatments	Subject will be asked to rate the level of discomfort felt (1) during the treatment and (2) 5-10 minutes after the treatment using the VAS Pain Scale.	During the treatments period (up to 6 month)
Subject satisfaction Questionnaire (4-8 weeks post-final treatment)	4-8 weeks post the last treatment. They will be also asked to complete satisfaction questionnaire to evaluate the level of subject's satisfaction of tattoo clearing results.	4-8 weeks post-final treatment (up to 6 month)

Collaborators and Investigators

• Sponsor: LigthSense Israel Ltd
• Investigators: Principal Investigator: Ruta Ganceviciene,, Dr, Santara KTC

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2019
• Primary Completion (Anticipated): August 31, 2019
• Study Completion (Anticipated): August 31, 2019

Study Registration Dates

• First Submitted: February 27, 2019
• First Submitted That Met QC Criteria: March 6, 2019
• First Posted (Actual): March 7, 2019

Study Record Updates

• Last Update Posted (Actual): March 7, 2019
• Last Update Submitted That Met QC Criteria: March 6, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: CLN-ST-01-PR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No