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

Soliton

Status

Completed

Conditions

Tattooing

Treatments

Device: Soliton Acoustic Wave Device

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03125824

Soliton 2017-001

Details and patient eligibility

About

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

Full description

To further evaluate accelerated fading resulting from additional treatment sessions of multi-pass Q-Switched laser with the Soliton Planar Acoustic Wave Device System (AWD) as an accessory to Q-Switched laser in tattoo reduction treatment.

Enrollment

20 patients

Sex

All

Ages

22 to 65 years old

Volunteers

No Healthy Volunteers

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.