NCT02877667

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 24, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2017

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2017

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

10 months

First QC Date

August 19, 2016

Last Update Submit

July 27, 2020

Conditions

Tattoo

Keywords

tattoolaser

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Efficacy comparison of tattoo fading of laser versus laser and Acoustic Wave Device treated tattoos .

    12 weeks

Study Arms (1)

Open label device treatment

EXPERIMENTAL

Up to four passes with Q-Switched laser alternating with acoustic wave device

Device: planar acoustic wave device

Interventions

planar acoustic wave deviceDEVICE

accessory to laser treatment

Also known as: AWD
Open label device treatment

Eligibility Criteria

Age22 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SkinCare Physicians

Chestnut Hill, Massachusetts, 02467, United States

Location

Study Officials

  • Chris Capelli, MD

    Soliton

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2016

First Posted

August 24, 2016

Study Start

July 1, 2016

Primary Completion

April 19, 2017

Study Completion

April 30, 2017

Last Updated

July 29, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)