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

Tattoo Clinical Trial

— SOL1601  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02877667
• Other study ID #: Soliton 2016-001
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: April 30, 2017

Study information

• Verified date: July 2020
• Source: Soliton
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study of new acoustic wave device as an accessory to laser treatment in tattoo reduction.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 30, 2017
• Est. primary completion date: April 19, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 65 Years

Eligibility

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.).

Related Conditions & MeSH terms

• Tattoo

Intervention

Device:
• planar acoustic wave device
accessory to laser treatment

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	Demonstrate that multiple passes with Quality Switched Yag laser is safe based on assessment of Adverse Events	Safety assessments included reported Adverse Events as a result of physician examination	1 day
Secondary	Efficacy comparison of tattoo fading of laser versus laser and Acoustic Wave Device treated tattoos .	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