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Evaluate safety and efficacy of S2 multi-wavelength laser for tattoo removal
The purpose of this investigation is to evaluate safety and efficacy of S2 multi-wavelength laser for tattoo removal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Picosecond Laser | Experimental | Treatment with investigational wavelengths of the S2 laser for tattoo removal. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device: S2 Picosecond laser | Device | Each subject will receive up to 16 laser treatments. |
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| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Linas Leikis, Dr | Contact | (+370) 612 25255 | linas.liekis@inlita.lt |
| Name | Affiliation | Role |
|---|---|---|
| Ruta Ganceviciene,, Dr | Santara KTC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santara KTC (clinical trial site) | Recruiting | Vilnius | 08406 | Lithuania |
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| 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) |