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Clinical Trials/NCT02877667
NCT02877667CompletedNot Applicable

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

Soliton2 sites in 1 country40 target enrollmentStarted: July 1, 2016Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Soliton
Enrollment
40
Locations
2
Primary Endpoint
Demonstrate that multiple passes with Quality Switched Yag laser is safe based on assessment of Adverse Events
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

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
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
22 Years to 65 Years (Adult, Older Adult)
Sex
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.).

Outcomes

Primary Outcomes

Demonstrate that multiple passes with Quality Switched Yag laser is safe based on assessment of Adverse Events

Time Frame: 1 day

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

Secondary Outcomes

  • Efficacy comparison of tattoo fading of laser versus laser and Acoustic Wave Device treated tattoos .(12 weeks)

Investigators

Sponsor
Soliton
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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