Performance Evaluation of Tattoo Removal

Tattoo Removal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03866304
• Other study ID #: CLN-ST-01-PR
• Status: Recruiting
• Phase: N/A
• Start date: January 21, 2019
• Est. completion date: August 31, 2019

Study information

• Verified date: March 2019
• Source: LigthSense Israel Ltd
• Contact: Linas Leikis, Dr
• Phone: (+370) 612 25255
• Email: linas.liekis[@]inlita.lt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tattoo Removal

Intervention

Device:
• Device: S2 Picosecond laser
Each subject will receive up to 16 laser treatments.

Locations

Country	Name	City	State
Lithuania	Santara KTC (clinical trial site)	Vilnius

Sponsors (1)

Lead Sponsor	Collaborator
LigthSense Israel Ltd

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)