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

Soliton40 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Tattoo

Interventions

planar acoustic wave deviceDEVICE

accessory to laser treatment

Eligibility

Sex: ALLMin age: 22 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.).

Locations (1)

SkinCare Physicians

Chestnut Hill, Massachusetts, United States

Outcomes

Primary Outcomes

Demonstrate that multiple passes with Quality Switched Yag laser is safe based on assessment of Adverse Events

Safety assessments included reported Adverse Events as a result of physician examination

Time frame: 1 day

Secondary Outcomes

Efficacy comparison of tattoo fading of laser versus laser and Acoustic Wave Device treated tattoos .

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%

Time frame: 12 weeks

Data from ClinicalTrials.gov

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