We do not currently have documented clinical trials for the darkest skin tone shades on the Fitzpatrick scale, or skin tones in ranges 5 & 6. The reason is simply because we lacked the necessary subjects in our last clinical study, in which we only had 13 participants with darker skin tone. The FDA would not allow us to include the higher end of the pigment chart without a minimum number of 22 women. Our past clinical study was conducted in an area that had a low demographic of darker skinned people. Additionally, the physician who conducted the study had very few patients of this particular demographic.
The good news is that subjects with darker pigmentation have experienced better results with Theradome. This is due to the fact darker tones absorb laser light more readily. In fact, our CEO and inventor of the Theradome helmet has a medium to dark complexion. Additionally, many of our testimonials come from darker-skinned customers. This artificial limit, set by the FDA, was based on previous laser systems that relied on heat, our laser helmet does NOT heat up the skin/scalp so the Fitzpatrick scale is really unnecessary from our viewpoint. But we have to state on our documentation that Fitzpatrick above scale of 4 has been undocumented for the sake of being transparent to our customers and clients.
You may find this our article useful: https://www.theradome.com/dark-skin-laser-hair-growth/.