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Completed

NCT Number: NCT02877667

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

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

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Key information

Conditions

Tattoo

Age range

22 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SkinCare Physicians

Chestnut Hill, Massachusetts, 02467, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

planar acoustic wave device

Device

accessory to laser treatment

Other names: AWD

Primary outcomes

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

    Time frame: 1 day

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

Secondary outcomes

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

    Time frame: 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%

Sponsors and collaborators

Lead sponsor

Soliton

Industry

Collaborators

  • MedSource LLC

Registry information

Acronym: SOL1601

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 24, 2016
Registry last updated
Jul 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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