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

Not Applicable

Completed

• Conditions: Tattooing
• Interventions: Device: Soliton Acoustic Wave Device

• Registration Number: NCT03125824
• Lead Sponsor: Soliton

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.

Study Timeline

• Study Start: 2017-02-13
• Study First Submitted: 2017-04-06
• Study First Submitted QC: 2017-04-19
• Study First Posted: 2017-04-24
• Primary Completion: 2018-05-23
• Study Completion: 2018-09-25
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-08
• Last Update Posted: 2022-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tattoos previously treated in Soliton 2016-001 trial	Soliton Acoustic Wave Device	Identical tattoos treated by Laser + AWD in Soliton's previous trial

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Incidence of Treatment Emergent Adverse Events for Safety Reporting	12 weeks	Adverse Events and complications evaluated for severity and device relationship

Trial Locations

Locations (1)

SkinCare Physicians; 🇺🇸 Chestnut Hill, Massachusetts, United States