Soliton Planar Acoustic Wave Device System for Dermal Tattoo Clearing Human Trial Protocol

Completed · Not applicable

Conditions studied: Tattooing

In brief

To further evaluate accelerated fading resulting from additional treatment sessions of Soliton AWD as accessory to laser in tattoo reduction treatment.

Key facts

Study ID

NCT03125824

Run by

Soliton

People needed

20

Starts

2017-02-13

Expected to finish

2018-09-25

Last updated by the study team

2022-02-14

Who can join

Age: 22 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• SkinCare Physicians — Chestnut Hill, Massachusetts, United States

Full record on ClinicalTrials.gov

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