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

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

Detailed Description
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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.

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

Conditions
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Tattooing

Intervention / Treatment
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* Device: Soliton Acoustic Wave Device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single Group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Tattoos previously treated in Soliton 2016-001 trial<br>Identical tattoos treated by Laser + AWD in Soliton's previous trial | Device: Soliton Acoustic Wave Device<br>* Treatment of tattoos with Soliton Acoustic Wave Device as an accessory to laser<br>* Other names: AWD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tattoo clearance | To evaluate changes in accelerated fading of previously treated tattoos from original treatment with additional treatment sessions of Soliton Acoustic Wave Device as an accessory to laser treatment through comparison of photographic evidence. Changes are measured by comparing photos of the tattoos after the original treatment to photos of the tattoos after additional treatment. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment Emergent Adverse Events for Safety Reporting | Adverse Events and complications evaluated for severity and device relationship | 12 weeks |