Soliton Planar Acoustic Wave Device System for Dermal Clearing Human Trial Protocol (SOL1601)

July 27, 2020 updated by: Soliton
Study of new acoustic wave device as an accessory to laser treatment in tattoo reduction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open label device treatment
Up to four passes with Q-Switched laser alternating with acoustic wave device
Device: planar acoustic wave device
accessory to laser treatment
Other Names:
  • AWD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soliton

Collaborators

MedSource LLC

Investigators

  • Study Director: Chris Capelli, MD, Soliton

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

April 19, 2017

Study Completion (Actual)

April 30, 2017

Study Registration Dates

First Submitted

August 19, 2016

First Submitted That Met QC Criteria

August 23, 2016

First Posted (Estimate)

August 24, 2016

Study Record Updates

Last Update Posted (Actual)

July 29, 2020

Last Update Submitted That Met QC Criteria

July 27, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Soliton 2016-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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