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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02877667

Acronym

SOL1601

Enrollment

Registered

2016-08-24

Start date

2016-07-31

Completion date

2017-04-30

Last updated

2020-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tattoo

Keywords

tattoo, laser

Brief summary

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

Detailed 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.

Interventions

DEVICEplanar acoustic wave device

accessory to laser treatment

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

22 Years to 65 Years

Healthy volunteers

Yes

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.).

Design outcomes

Primary

Measure	Time frame	Description
Demonstrate that multiple passes with Quality Switched Yag laser is safe based on assessment of Adverse Events	1 day	Safety assessments included reported Adverse Events as a result of physician examination

Secondary

Measure	Time frame	Description
Efficacy comparison of tattoo fading of laser versus laser and Acoustic Wave Device treated tattoos .	12 weeks	The degree of fading assessed in terms of percentage fading (1-100%) and according to the following 1 to 5 scale: * 1 = 0%; * 2 = 1-25%; * 3 = 26-49%; * 4 = 50-75%; or * 5 = 76-100%

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026