TattooingNCT03125824
Soliton Planar Acoustic Wave Device System for Dermal Tattoo Clearing Human Trial Protocol
A study testing Soliton Acoustic Wave Device in people with Tattooing, run by Soliton at 1 site in United States.
Trial summary
To further evaluate accelerated fading resulting from additional treatment sessions of Soliton AWD as accessory to laser in tattoo reduction treatment. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Tattooing
- What is being tested?
- Soliton Acoustic Wave Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2017to 25 Sep 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Range of Fitzpatrick skin color scores I to III
- The identical tattoo located on the arms, legs, and torso treated by Q-Switched laser and Laser + AWD during Soliton's previous 2016-001 clinical trial
- Black ink only. Other ink colors may be present, but areas of black only tattoo should meet inclusion criteria
- Approximately 1" x 3" tattoo with at least 30-50% of the treatment area containing black tattoo ink
Who cannot join
- Subject is pregnant or planning to become pregnant during the duration of the study
- Medical disorder that would hinder the wound healing or immune response (no blood disorder, diabetes, inflammatory disease, etc.)
- Skin disorders (skin infections or rashes, scarring, moles,birthmarks, psoriasis, etc.)
- Any surgical procedure in the prior 3 months, or planned during the duration of the study
- Active electronic implants such as pacemakers, defibrillators, cochlear implants, nerve/brain stimulators, etc.
- Moderate to heavy tanning on and around the tattoo to be treated as determined by the Principle Investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
SkinCare Physicians
Chestnut Hill, Massachusetts, 02467
About this study
Official title: Soliton Planar Acoustic Wave Device System for Dermal Tattoo Clearing Human Trial
To further evaluate accelerated fading resulting from additional treatment sessions of Soliton AWD as accessory to laser in tattoo reduction treatment.
Read the detailed description
To further evaluate accelerated fading resulting from additional treatment sessions of multi-pass Q-Switched laser with the Soliton Planar Acoustic Wave Device System (AWD) as an accessory to Q-Switched laser in tattoo reduction treatment.
- Conditions
- Tattooing
- Being tested
- Soliton Acoustic Wave Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soliton Acoustic Wave DeviceDevice
Also called AWD
Treatment of tattoos with Soliton Acoustic Wave Device as an accessory to laser
| Study group | Role | What they receive |
|---|---|---|
| Tattoos previously treated in Soliton 2016-001 trial | Other | Identical tattoos treated by Laser + AWD in Soliton's previous trial Receives: Device: Soliton Acoustic Wave Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tattoo clearance
To evaluate changes in accelerated fading of previously treated tattoos from original treatment with additional treatment sessions of Soliton Acoustic Wave Device as an accessory to laser treatment through comparison of photographic evidence. Changes are measured by comparing photos of the tattoos after the original treatment to photos of the tattoos after additional treatment.
Measured: 12 weeks
Secondary outcomes (1)
Incidence of Treatment Emergent Adverse Events for Safety Reporting
Adverse Events and complications evaluated for severity and device relationship
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 Apr 2017
- Study start13 Feb 2017
- Primary completion23 May 2018
- Study completion25 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TattooingStudies 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
- Model description
- Single Group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soliton
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MedSource LLC
- Responsible party
- Sponsor
- Investigators
- Christopher Cappelli, MD, Study director, Soliton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03125824
- Sponsor's protocol ID
- Soliton 2017-001
- Status last verified
- Feb 2022
- First submitted
- 6 Apr 2017
- Last updated
- 14 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soliton Planar Acoustic Wave Device System for Dermal Tattoo Clearing Human Trial
- ClinicalTrials.gov ID
- NCT03125824
- Acronym / sponsor ID
- Soliton 2017-001
- Conditions
- Tattooing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- SolitonIndustry (pharma, biotech, devices)
- Collaborators
- MedSource LLC
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- 23 May 2018 (actual)
- Study completion
- 25 Sep 2018 (actual)
- First posted
- 24 Apr 2017 (actual)
- 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.
To further evaluate accelerated fading resulting from additional treatment sessions of Soliton AWD as accessory to laser in tattoo reduction treatment.
Detailed description
To further evaluate accelerated fading resulting from additional treatment sessions of multi-pass Q-Switched laser with the Soliton Planar Acoustic Wave Device System (AWD) 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
- Model description
- Single Group
| Arm | Type | Receives |
|---|---|---|
| Tattoos previously treated in Soliton 2016-001 trial | Other | Device: Soliton Acoustic Wave DeviceIdentical tattoos treated by Laser + AWD in Soliton's previous trial |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Range of Fitzpatrick skin color scores I to III
- The identical tattoo located on the arms, legs, and torso treated by Q-Switched laser and Laser + AWD during Soliton's previous 2016-001 clinical trial
- Black ink only. Other ink colors may be present, but areas of black only tattoo should meet inclusion criteria
- Approximately 1" x 3" tattoo with at least 30-50% of the treatment area containing black tattoo ink
Key exclusion criteria (6 listed)
- Subject is pregnant or planning to become pregnant during the duration of the study
- Medical disorder that would hinder the wound healing or immune response (no blood disorder, diabetes, inflammatory disease, etc.)
- Skin disorders (skin infections or rashes, scarring, moles,birthmarks, psoriasis, etc.)
- Any surgical procedure in the prior 3 months, or planned during the duration of the study
- Active electronic implants such as pacemakers, defibrillators, cochlear implants, nerve/brain stimulators, 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 |
|---|---|---|
| Soliton Acoustic Wave DeviceAlso: AWDTreatment of tattoos with Soliton Acoustic Wave Device as an accessory to laser | Device | Tattoos previously treated in Soliton 2016-001 trial |
Primary outcome
Tattoo clearance
Time frame: 12 weeks
To evaluate changes in accelerated fading of previously treated tattoos from original treatment with additional treatment sessions of Soliton Acoustic Wave Device as an accessory to laser treatment through comparison of photographic evidence. Changes are measured by comparing photos of the tattoos after the original treatment to photos of the tattoos after additional treatment.
1 secondary outcome
Incidence of Treatment Emergent Adverse Events for Safety Reporting
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 14 Feb 2022.
- 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.
Christopher Cappelli, 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 Soliton Acoustic Wave Device in people with Tattooing, 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 6 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 14 Feb 2022. 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?
Tattoo clearance (time frame: 12 weeks). 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 14 Feb 2022.