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

Sponsor
Soliton (Industry)
Overall Status
Completed
CT.gov ID
NCT03125824
Collaborator
MedSource LLC (Other)
20
Enrollment
1
Location
1
Arm
19.4
Actual Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Soliton Acoustic Wave Device
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Single GroupSingle Group
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Soliton Planar Acoustic Wave Device System for Dermal Tattoo Clearing Human Trial
Actual Study Start Date :
Feb 13, 2017
Actual Primary Completion Date :
May 23, 2018
Actual Study Completion Date :
Sep 25, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Tattoo clearance [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 Outcome Measures

    1. Incidence of Treatment Emergent Adverse Events for Safety Reporting [12 weeks]

      Adverse Events and complications evaluated for severity and device relationship

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 SkinCare Physicians Chestnut Hill Massachusetts United States 02467

    Sponsors and Collaborators

    • Soliton
    • MedSource LLC

    Investigators

    • Study Director: Christopher Cappelli, MD, Soliton

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Soliton
    ClinicalTrials.gov Identifier:
    NCT03125824
    Other Study ID Numbers:
    • Soliton 2017-001
    First Posted:
    Apr 24, 2017
    Last Update Posted:
    Feb 14, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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

    Study Results

    No Results Posted as of Feb 14, 2022