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

Completed · Not applicable

Conditions studied: Tattoo

In brief

Study of new acoustic wave device as an accessory to laser treatment in tattoo reduction.

Key facts

Study ID

NCT02877667

Run by

Soliton

People needed

40

Starts

2016-07-01

Expected to finish

2017-04-30

Last updated by the study team

2020-07-29

Who can join

Age: 22 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Range of Fitzpatrick skin color scores I to III
• Tattoo with location on arms, legs, and torso only, and accessible to AWD treatment head. Black ink only. Other ink colors may be present, but areas of black only tattoo should meet criteria described as: minimum 1" x 3" tattoo with at least 30-50% consistent coverage (see fig 1).
• Tattoo age between 1 and 20 years.
• Professionally applied.

You may not qualify if…

• Subject is pregnant or planning to become pregnant during the duration of the study.
• Prior tattoo removal procedures on target tattoo.
• Self-applied or amateur tattoo.
• Tattoo layering (additional tattoo placed over an older tattoo to hide it) on target tattoo.
• Metal or plastic implants in the area of the tattoo (pacemaker, implanted defibrillator, stent, or implants in the hips, knees, elbows, etc.).

Where it is running

• SkinCare Physicians — Chestnut Hill, Massachusetts, United States

Full record on ClinicalTrials.gov

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