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CompletedNCT03125824Updated Feb 14, 2022

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

An interventional study of Soliton Acoustic Wave Device in Tattooing, sponsored by Soliton. Completed at 1 site in United States. Open to participants aged 22 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-02-14.

Sponsored by Soliton · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was May 2018, 8 years 5 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
22 Years to 65 Years
Sex
All
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Tattooing
03

In context

Lead sponsor

Soliton is the lead sponsor of 7 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Other
    Tattoos previously treated in Soliton 2016-001 trial

    Identical tattoos treated by Laser + AWD in Soliton's previous trial

    Device: Soliton Acoustic Wave Device

Interventions

  • DeviceSoliton Acoustic Wave Device

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

    Also known as: AWD

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 weeks

Secondary outcomes

  1. Incidence of Treatment Emergent Adverse Events for Safety Reporting

    Adverse Events and complications evaluated for severity and device relationship

    Time frame: 12 weeks

07

Study locations

1 site
  • SkinCare Physicians
    Chestnut Hill, Massachusetts 02467, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03125824
Lead sponsor
Soliton
Collaborators
MedSource LLC
Responsible party
Sponsor
First posted
Apr 24, 2017
Start date
Feb 13, 2017
Primary completion
May 23, 2018
Completion
Sep 25, 2018
Last update
Feb 14, 2022

Study contacts

Christopher Cappelli, MD
study director · Soliton

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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