SOL1601: Soliton Planar Acoustic Wave Device System for Dermal Clearing Human Trial Protocol

• Sponsor: Soliton (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02877667
• Collaborator: MedSource LLC (Other)
• Enrollment: 40
• Location: 1
• Arm: 1
• Duration (Months): 10
• Patients Per Site Per Month: 4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Tattoo	Device: planar acoustic wave device	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Soliton Planar Acoustic Wave Device System for Dermal Clearing Human Trial Protocol
• Study Start Date: Jul 1, 2016
• Actual Primary Completion Date: Apr 19, 2017
• Actual Study Completion Date: Apr 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Open label device treatment Up to four passes with Q-Switched laser alternating with acoustic wave device	Device: planar acoustic wave device; accessory to laser treatment; Other Names: AWD

Outcome Measures

Primary Outcome Measures

1. Demonstrate that multiple passes with Quality Switched Yag laser is safe based on assessment of Adverse Events [1 day]

   Safety assessments included reported Adverse Events as a result of physician examination

Secondary Outcome Measures

1. Efficacy comparison of tattoo fading of laser versus laser and Acoustic Wave Device treated tattoos . [12 weeks]

   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%

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.).

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: Chris Capelli, MD, Soliton

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Soliton
• ClinicalTrials.gov Identifier: NCT02877667
• Other Study ID Numbers: Soliton 2016-001
• First Posted: Aug 24, 2016
• Last Update Posted: Jul 29, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Soliton: tattoo; laser

Study Results

No Results Posted as of Jul 29, 2020