Tattoo Removal Trials
Tattoo Human Correlation Trial 1
An initial human clinical trial was conducted to demonstrate the dispersion of tattoo pigment. In Phase 1, three patients with black tattoos in various locations (lower back, lower leg and shoulder) were selected. Two tattoo sites on each patient were treated with a single pass of the RAP Device. Both sites were biopsied, one immediately and the other 24 hours post treatment. All biopsies in all patients demonstrated pigment dispersion from macrophages.
In Phase 2, six patients were selected for a single treatment session to demonstrate tattoo fading. A single black tattoo was selected and divided into three adjacent areas, with two of the areas to be treated and the third area remaining untreated as a control for comparison to the treated areas. One area was treated with a single laser treatment (Laser Only) while the other area was treated with multiple laser treatment, each separated by a treatment with the RAP Device (Laser+RAP). Each laser pass increased in laser fluence and spot size.
Dermal vacuolization was immediately identified in all tattoos treated with a laser. Minimal dermal clearing was detected 5 minutes post treatment in the Laser Only treatment areas. Significant dermal clearing was immediately identified in the Laser+RAP treatment areas. The trial also offered important conclusions to the treatment protocol. The importance of preventing thermal damage to the tattoo site resulting from multiple laser passes is critical.
Tattoo Human Correlation Trial 2
In this image, section A on the left was treated with laser-only, and section B on the right was treated with laser and Soliton's RAP technology.
In this image, section A on the left was treated with laser-only, and section B on the right was treated with laser and Soliton's RAP technology.
The multiple pass method was again tested in humans in a pivotal clinical trial (HCT-2) involving 22 patients and 32 tattoos. Patients were aged 22-65, had Fitzpatrick skin color scores of I to III, and had at least one tattoo on the arms, legs or torso accessible to the RAP treatment hand piece with at least 30-50% of the tattoo area to be treated (approximately 1” x 3”) containing black ink only. Each tattoo selected for treatment was divided into three adjacent areas, with the assignment of two areas to be treated, one labeled ‘Laser Only’ and the other ‘Laser + RAP’. The third area (generally the middle area between the two treated areas) remained untreated as a control for comparison to treated areas. The treatments were administered during a single office visit.
The Laser + RAP area received a Laser treatment generally in the 4 J/cm2 and 4 mm spot size range followed by a 1-minute RAP treatment. Fluence on successive laser treatments was increased or decreased as necessary to result in an audible ‘snap’ caused by laser energy absorption by the tattoo ink. Each laser treatment was followed by another 1-minute RAP treatment except for the last laser treatment; no RAP treatment followed the final laser treatment. The treatment area was covered by a hydrogel pad and aggressively chilled with forced cool air from a Zimmer chiller throughout the Laser + RAP treatment. The Laser Only treatment area used a 1064 nm Q-Switched laser; the fluence and spot size were matched to the initial settings used in the Laser + RAP treatment.
The primary objective of the study was to demonstrate that multiple passes of the Q-switched Laser + RAP treatment could be administered in a single treatment session. The mean number of Q-switched Laser + RAP delivered passes was 4.16. The secondary objective was to assess the degree of tattoo fading from a single treatment session for both the Q-switched Laser + RAP treatment and the Q-switched Laser Only treatment. Assessment by both Blinded and Non-Blinded Reviewers at 12 weeks indicated that there was accelerated fading for Laser + RAP in comparison to Laser Only. Specifically, 72% of the tattoos treated with the Laser + RAP had a good, excellent or complete response (>25% fading) compared to 40% of the tattoos treated with Laser Only.
Tattoo Human Correlation Trial 3
HCT-3 built upon HCT-2 by bringing back 10 HCT-2 subjects (12 tattoos) for a second treatment session and, in those who needed it, a third treatment session (each again separated by 6-8 weeks). The Laser + RAP in HCT-3 again outperformed Laser Only, with subjects showing an average of 80% fading after only two visits vs. 44% for Laser Only. After 3 Soliton Multi-Pass treatments, 100% of the treated tattoos had a ‘Complete’ (76-100% faded) response; in comparison, only 17% of the tattoos treated with the Laser Only had a ‘Complete’ response.
Cellulite Trials
Cellulite Proof-of-Concept Study
The Proof-of-Concept (POC) Trial involved a study of five patients with moderate to severe cellulite, each treated on their thighs, with Soliton’s RAP device.
In a single 20-minute, non-invasive treatment, the (RAP) device was applied to the surface of the patients’ skin. The treatments required no anesthesia, caused no bruising, swelling or bleeding, and were evaluated as relatively painless by the trial participants, none of whom experienced any post-treatment discomfort or downtime. Follow-up assessments were performed at 3 months and 6 months.
At 3 months, approximately 97% of treatments were rated 0 on a 0 to 10-point pain scale (with 0 being no pain). At the end of the 12-week POC Trial, in a blinded review by doctors of before and after photos, 100 percent correctly identified which photo was the “after.” The three blinded reviewers, who are trained in the use of the cellulite severity scoring system, scored the before and after photos using the 5-point system. 100% of the patients showed clinical improvement. The range of improvement in cellulite severity score was 20% to 47% and the average improvement for all patients was nearly a 30% improvement (1.24 reduction on the 0 to 5-point cellulite severity scale). As a point of reference, the only FDA
The Global Aesthetic Improvement Scale (GAIS) 5-point scale was used to evaluate changes between the 3-month and 6-month timepoints and patients improved, on average, a full point on this scale.
Cellulite Pivotal Study
The pivotal cellulite clinical trial enrolled and treated 67 subjects at four clinical sites, of which 62 subjects were evaluated in the results analysis. A follow-up visit was conducted at three months. Before and After photos were evaluated by independent, blinded physicians for improvement on the Cellulite Severity Scale.
The Soliton clinical trial protocol provided for a single 20 to 30-minute, non-invasive treatment in which the Rapid Acoustic Pulse (RAP) device was applied to the surface of the subjects’ skin. The treatment required no anesthesia, caused no unexpected or serious adverse events, had strong patient satisfaction and was evaluated as relatively painless by the trial subjects, with an average pain score of 2.4 out of 10.
