Soliton Planar Acoustic Wave Device System for Dermal Clearing Human Trial Protocol (SOL1601)

Soliton

Status

Completed

Conditions

Tattoo

Treatments

Device: planar acoustic wave device

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02877667

Soliton 2016-001

Details and patient eligibility

About

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

Full description

A non-significant risk, single center, prospective device trial to evaluate the number of passes of Q-Switch laser treatment that can be completed with a Q-Switch Laser alone compared to use of the Soliton Planar Acoustic Wave Device System (AWD) System as an accessory to Q-switched laser in tattoo reduction treatment.

Enrollment

40 patients

Sex

All

Ages

22 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.).