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

NCT ID: NCT03125824

Last Updated: 2022-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-13
• Study Completion Date: 2018-09-25

Brief Summary

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

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.

Conditions

Tattooing

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tattoos previously treated in Soliton 2016-001 trial

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

Group Type: OTHER

Soliton Acoustic Wave Device

Intervention Type: DEVICE

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

Interventions

Soliton Acoustic Wave Device

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

Intervention Type: DEVICE

Other Intervention Names

AWD

Eligibility Criteria

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
• 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.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MedSource LLC

OTHER

Sponsor Role: collaborator

Soliton

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Cappelli, MD

Role: STUDY_DIRECTOR

Soliton

Locations

SkinCare Physicians

Chestnut Hill, Massachusetts, United States

Countries

United States

Other Identifiers

Soliton 2017-001

Identifier Type: -

Identifier Source: org_study_id