Soliton Planar Acoustic Wave Device System for Dermal Tattoo Clearing Human Trial Protocol (NCT03125824) | Clinical Trial Compass
CompletedNot Applicable
Soliton Planar Acoustic Wave Device System for Dermal Tattoo Clearing Human Trial Protocol
United States20 participantsStarted 2017-02-13
Plain-language summary
To further evaluate accelerated fading resulting from additional treatment sessions of Soliton AWD as accessory to laser in tattoo reduction treatment.
Who can participate
Age range22 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Range of Fitzpatrick skin color scores I to III
* The identical tattoo located on the arms, legs, and torso treated by Q-Switched laser and Laser + AWD during Soliton's previous 2016-001 clinical trial
* Black ink only. Other ink colors may be present, but areas of black only tattoo should meet inclusion criteria
* Approximately 1" x 3" tattoo with at least 30-50% of the treatment area containing black tattoo ink
Exclusion Criteria:
* Subject is pregnant or planning to become pregnant during the duration of the study
* Medical disorder that would hinder the wound healing or immune response (no blood disorder, diabetes, inflammatory disease, etc.)
* Skin disorders (skin infections or rashes, scarring, moles,birthmarks, psoriasis, etc.)
* Any surgical procedure in the prior 3 months, or planned during the duration of the study
* Active electronic implants such as pacemakers, defibrillators, cochlear implants, nerve/brain stimulators, etc.
* Moderate to heavy tanning on and around the tattoo to be treated as determined by the Principle Investigator.