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NCT07759076
Evaluation of Automated Laser-Assisted Tattoo Removal: a Prospective Feasibility Clinical Study
Conditions: Persons Seeking Tattoo Removal
Sex: All
Ages: 18 Years – 84 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 10
Sponsor: Raylution AG
Location: Re.Naissance Basel Canton of Basel-City
Summary
The goal of this study is to collect preliminary clinical performance data focused on the usability aspects of the human - machine interaction, with focus on planning, navigation and application of automated laser tattoo removal. The study will enroll adult patients with monochrome dark tattoos.
In addition to the data collected on the human-machine interaction, it will also collect other outcomes like pain during treatment, overall user and patient satisfaction, and adverse events.
For the participants, treatment will follow standard procedures. In addition to this, they will be followed up after 30 days, to see if any complications occured.
Eligibility Criteria
Inclusion criteria:
* Adults (18 - 84 years)
* Woman or man (for women in their reproductive age, a confirmation of a pregnancy test with negative result is mandatory)
* Fitzpatrick skin types I-VI
* Monochrome dark tattoo (black, dark grey, dark blue, dark green, dark red, puce)
* Tattoo size ≤ A5 (311 cm2)
Exclusion Criteria:
* Patients with absolute or relative contraindications (according to IFU)
* Pregnancy or breastfeeding
* History of keloids or hypertrophic scarring
* Active skin infections or conditions at the tattoo site
* Use of photosensitizing medications
Source: ClinicalTrials.gov (NCT07759076). StuddyBuddy aggregates publicly available trial information.