Tattooing
Conditions
Brief summary
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.
Interventions
DEVICESoliton Acoustic Wave Device
Treatment of tattoos with Soliton Acoustic Wave Device as an accessory to laser
Sponsors
MedSource LLC
Soliton
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single Group
Eligibility
Sex/Gender
ALL
Age
22 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tattoo clearance | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment Emergent Adverse Events for Safety Reporting | 12 weeks | Adverse Events and complications evaluated for severity and device relationship |
Countries
United States
Outcome results
None listed