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Completed

NCT Number: NCT03125824

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

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

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Key information

Conditions

Tattooing

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

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Soliton Acoustic Wave Device

Device

Treatment of tattoos with Soliton Acoustic Wave Device as an accessory to laser

Other names: AWD

Primary outcomes

  1. Tattoo clearance

    Time frame: 12 weeks

    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.

Secondary outcomes

  1. Incidence of Treatment Emergent Adverse Events for Safety Reporting

    Time frame: 12 weeks

    Adverse Events and complications evaluated for severity and device relationship

Sponsors and collaborators

Lead sponsor

Soliton

Industry

Collaborators

  • MedSource LLC

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 24, 2017
Registry last updated
Feb 14, 2022

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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