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

NCT03125824 | Completed FDA Device

• 1 other identifier: Soliton 2017-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tattooing

Outcome Measures

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.

  12 weeks

Secondary Outcomes (1)

• Incidence of Treatment Emergent Adverse Events for Safety Reporting

  12 weeks

Study Arms (1)

Tattoos previously treated in Soliton 2016-001 trial

OTHER

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

Device: Soliton Acoustic Wave Device

Interventions

Soliton Acoustic Wave Device DEVICE

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

Also known as: AWD

Tattoos previously treated in Soliton 2016-001 trial

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Approximately 1" x 3" tattoo with at least 30-50% of the treatment area containing black tattoo ink

You may not qualify if:

• 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.

Sponsors & Collaborators

• Soliton: lead
• MedSource LLC: collaborator

Study Sites (1)

SkinCare Physicians

Chestnut Hill, Massachusetts, 02467, United States

Location

Study Officials

• Christopher Cappelli, MD

  Soliton

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Group

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 24, 2017
• Study Start: February 13, 2017
• Primary Completion: May 23, 2018
• Study Completion: September 25, 2018
• Last Updated: February 14, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)