Tattoo RemovalNCT03866304
Performance Evaluation of Tattoo Removal
A study testing Device: S2 Picosecond laser in people with Tattoo Removal, run by LigthSense Israel Ltd at 1 site in Lithuania.
Trial summary
Evaluate safety and efficacy of S2 multi-wavelength laser for tattoo removal Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tattoo Removal
- What is being tested?
- Device: S2 Picosecond laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteLithuania
- Study dates
- 21 Jan 2019to 31 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Lithuania1 site, 1 recruiting
- Recruiting
Santara KTC (clinical trial site)
Vilnius, 08406
Linas Leikis, Dr, (+370) 612 25255, linas.liekis@inlita.lt
About this study
Official title: 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
Read the detailed description
The purpose of this investigation is to evaluate safety and efficacy of S2 multi-wavelength laser for tattoo removal.
- Conditions
- Tattoo Removal
- Being tested
- Device: S2 Picosecond laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: S2 Picosecond laserDevice
Each subject will receive up to 16 laser treatments.
| Study group | Role | What they receive |
|---|---|---|
| Picosecond Laser | Experimental | Treatment with investigational wavelengths of the S2 laser for tattoo removal. Receives: Device: Device: S2 Picosecond laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%)
Measured: 8 weeks post-final treatment (up to 6 month)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4-8 weeks post-final treatment (up to 6 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start21 Jan 2019
- Primary completion31 Aug 2019 (estimated)
- Study completion31 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tattoo RemovalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LigthSense Israel Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ruta Ganceviciene,, Dr, Principal investigator, Santara KTC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03866304
- Sponsor's protocol ID
- CLN-ST-01-PR
- Status last verified
- Mar 2019
- First submitted
- 27 Feb 2019
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label, Uncontrolled Pilot Study to Evaluate the Safety and Efficacy of S2 - Multi-Wavelength Laser for Tattoo Removal
- ClinicalTrials.gov ID
- NCT03866304
- Acronym / sponsor ID
- CLN-ST-01-PR
- Conditions
- Tattoo Removal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- LigthSense Israel LtdIndustry (pharma, biotech, devices)
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- 31 Aug 2019 (estimated)
- Study completion
- 31 Aug 2019 (estimated)
- First posted
- 7 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Picosecond Laser | Experimental | Device: Device: S2 Picosecond laserTreatment with investigational wavelengths of the S2 laser for tattoo removal. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device: S2 Picosecond laserEach subject will receive up to 16 laser treatments. | Device | Picosecond Laser |
Primary outcome
Tattoo clearing
Time frame: 8 weeks post-final treatment (up to 6 month)
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%)
4 secondary outcomes
Degree of tattoo clearing as assessed by PGA
Time frame: 8 weeks post-final treatment (up to 6 month)
Degree of tattoo clearing at 8 weeks post-final treatment as assessed by Subject
Time frame: 8 weeks post-final treatment (up to 6 month)
Subject discomfort (pain) during treatments
Time frame: During the treatments period (up to 6 month)
Subject satisfaction Questionnaire (4-8 weeks post-final treatment)
Time frame: 4-8 weeks post-final treatment (up to 6 month)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
- Individual participant dataSharing planned: Undecided
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Hair Reduction, Tattoo Removal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruta Ganceviciene,, Dr principal investigator
Santara KTC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device: S2 Picosecond laser in people with Tattoo Removal, run by LigthSense Israel Ltd at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Linas Leikis, Dr ((+370) 612 25255, linas.liekis@inlita.lt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tattoo clearing (time frame: 8 weeks post-final treatment (up to 6 month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2019.