TattooSOL1601NCT02877667
Soliton Planar Acoustic Wave Device System for Dermal Clearing Human Trial Protocol
A study testing planar acoustic wave device in people with Tattoo, run by Soliton at 1 site in United States.
Trial summary
Study of new acoustic wave device as an accessory to laser treatment in tattoo reduction. Read more about this study
- Who is it for?
- Ages 22 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tattoo
- What is being tested?
- planar acoustic wave device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 30 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country.
United States1 site
SkinCare Physicians
Chestnut Hill, Massachusetts, 02467
About this study
Study of new acoustic wave device as an accessory to laser treatment in tattoo reduction.
Read the 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.
- Conditions
- Tattoo
- Being tested
- planar acoustic wave device
- Keywords
- tattoo, laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
planar acoustic wave deviceDevice
Also called AWD
accessory to laser treatment
| Study group | Role | What they receive |
|---|---|---|
| Open label device treatment | Experimental | Up to four passes with Q-Switched laser alternating with acoustic wave device Receives: Device: planar acoustic wave device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (1)
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%
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study startJul 2016
- Primary completion19 Apr 2017
- Study completion30 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TattooStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soliton
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MedSource LLC
- Responsible party
- Sponsor
- Investigators
- Chris Capelli, MD, Study director, Soliton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02877667
- Sponsor's protocol ID
- Soliton 2016-001
- Acronym
- SOL1601
- Status last verified
- Jul 2020
- First submitted
- 19 Aug 2016
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soliton Planar Acoustic Wave Device System for Dermal Clearing Human Trial Protocol
- ClinicalTrials.gov ID
- NCT02877667
- Acronym / sponsor ID
- SOL1601 / Soliton 2016-001
- Conditions
- Tattoo
- Keywords
- tattoo, laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- SolitonIndustry (pharma, biotech, devices)
- Collaborators
- MedSource LLC
- Study start
- Jul 2016
- Primary completion
- 19 Apr 2017 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 24 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open label device treatment | Experimental | Device: planar acoustic wave deviceUp to four passes with Q-Switched laser alternating with acoustic wave device |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| planar acoustic wave deviceAlso: AWDaccessory to laser treatment | Device | Open label device treatment |
Primary outcome
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
1 secondary outcome
Efficacy comparison of tattoo fading of laser versus laser and Acoustic Wave Device treated tattoos .
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Capelli, MD study director
Soliton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing planar acoustic wave device in people with Tattoo, run by Soliton at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrate that multiple passes with Quality Switched Yag laser is safe based on assessment of Adverse Events (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.