Tattoo removal rarely results in the tattoo site returning to the exact state it was in before there was a tattoo. Small traces of ink, bits of scar tissue and other anomalies are almost always there to some degree. To make matters even more complicated, it takes the body time to absorb whatever ink is broken up with each treatment session, so a faint image of the tattoo will usually be present after the final treatment session and can take many months for it to completely fade away.
Patients are often confronted with vague claims about tattoo removal times and sometimes outright misleading before and after photos of complete removals. It is not unusual to encounter websites that show what appears to be a complete tattoo removal that, upon closer inspection, is just an outright PhotoShop fake. With all of this in mind, we believe it is critical to be as clear as we can about our use of statistics and to help clinicians and patients build appropriate expectations.
While there is no unified standard for defining a successful tattoo removal, many tattoo removal device approvals by the FDA reference clinical trials that defined successful removal as greater than 75% fading. That typically means that a reviewer compared a picture of the final result to a picture of the untreated tattoo and concluded that the tattoo was more than 75% gone.
In our most recent clinical trial, all, meaning 100% – of the tattoos treated with Soliton RAP achieved 75% fading in just 3 office visits or less. In comparison, only 16.7% of tattoos treated with laser-only achieved that level of fading.
To be clear, this does not mean that every tattoo treated with Solion RAP will be completely gone after 3 office visits. Tattoos and patients vary and so will these results. What is clear from our clinical data is that using Soliton RAP is 3 or more times faster than the laser-only method.
So, let’s be more specific. This graph shows the average percentage of fading after each of 3 treatment sessions. You can see that 6 weeks after the first treatment session, tattoos treated with Soliton RAP averaged over 60% fading – from just one treatment session. It took 3 treatment sessions and 40 weeks for the laser-only tattoos to achieve that same level of fading. And, by that time, the average fading for the Soliton RAP tattoos had reached almost 93%.
Now, let’s look at some real examples from this same clinical trial. The tattoo of a vine shown here was treated within the dotted lines with Soliton RAP. You can see that after just 2 treatments the treated area is almost completely gone with some faint remnants of broken up ink particles still remaining. For reference, this was graded by reviewers as 90% faded after 2 treatments. But, when you see this same treated area one year later, it is nearly impossible to tell where the tattoo was because the body has had time to fully remove the remaining ink.
Here’s another example. The part of the flag treated with Soliton RAP is outlined in the before photo. You can see the significant impact after the first and second treatments, but once the body has had time to remove all of the broken-up ink, it’s virtually gone. By the way, these photos are not retouched in any way.
Using conventional laser-only removal methods, tattoos like this typically take 10 or more treatment sessions to achieve the same results. Whether you compare to historical controls or the laser-only controls in our statistically significant (p<.00001) clinical trial of 32 tattoos, the data supports our conclusion that Soliton RAP is 3 or more times faster than conventional methods.
We believe Soliton RAP will completely change the game in tattoo removal, which is why we are so excited about our becoming a public company, receiving FDA clearance for our device and launching this technology for all to use.