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

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

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

Study Overview

• Status: Completed
• Conditions: Tattooing
• Intervention / Treatment: Device: Soliton Acoustic Wave Device

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 02467
      • Skincare Physicians

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Treatment of tattoos with Soliton Acoustic Wave Device as an accessory to laser; Other Names: AWD

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Soliton
• Collaborators: MedSource LLC
• Investigators: Study Director: Christopher Cappelli, MD, Soliton

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 13, 2017
• Primary Completion (ACTUAL): May 23, 2018
• Study Completion (ACTUAL): September 25, 2018

Study Registration Dates

• First Submitted: April 6, 2017
• First Submitted That Met QC Criteria: April 19, 2017
• First Posted (ACTUAL): April 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 14, 2022
• Last Update Submitted That Met QC Criteria: February 8, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: Soliton 2017-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No