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A single-center prospective, open-label, uncontrolled study in 10 male or female subjects, age 18 to 65 years, who desire laser removal of a tattoo which contains all black ink.
This is a single-center prospective, open-label, uncontrolled study in 10 male or female subjects, age 18 to 65 years, who desire laser removal of a tattoo which contains all black ink. Subjects will receive up to 5 laser treatments, spaced 4 to 6 weeks apart, and will be followed at 3 months post-final treatment. Number of laser treatments required shall be based upon tattoo response to laser irradiation. The Investigator will terminate laser treatments upon 100% clearance of tattoo or after 5 treatment sessions, or in the event of an adverse effect which requires cessation of laser treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser Treatment | Experimental | Treatment to unwanted tattoo using a 532-nm KTP/1064-nm Nd:YAG Dual-Pulse Duration Laser |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 532-nm KTP/1064-nm Nd:YAG Dual-Pulse Duration Laser | Device | Cutera enlighten dual wavelength 532nm KTP/1064nm Nd:YAG laser |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physician's Global Assessment of improvement post-final treatment | Assessment of tattoo clearance by independent blinded reviewers | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Subject's Global Assessment of improvement post-final treatment | Assessment of tattoo clearance by subject | 3 months |
| Subject Satisfaction post-final treatment | Assessment of subject satisfaction with treatment results. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sheetal Sapra, MD | ICLS Dermatology and Plastic Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICLS Dermatology and Plastic Surgery | Oakville | Ontario | L6J 7W5 | Canada |
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| 3 months |
| Incidence and severity of adverse device effects | Assessment of ADEs immediately following each laser treatment and at the final follow-up visit. | Day 0, 4 wks, 8wks, 12 wks, 16 wks, 28 wks |