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

Tattooing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03125824
• Other study ID #: Soliton 2017-001
• Status: Completed
• Phase: N/A
• Start date: February 13, 2017
• Est. completion date: September 25, 2018

Study information

• Verified date: February 2022
• Source: Soliton
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 25, 2018
• Est. primary completion date: May 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tattooing

Intervention

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

Locations

Country	Name	City	State
United States	SkinCare Physicians	Chestnut Hill	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Soliton	MedSource LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of Treatment Emergent Adverse Events for Safety Reporting	Adverse Events and complications evaluated for severity and device relationship	12 weeks