About Low-Level Laser Therapy & Skin Tones
There have NEVER been any reported adverse effects for ANY skin tone (including the darkest of skin tones) using a Capillus device nor for any device using laser light at ~650 nm and <5mW.
All LLLT (Low-Level Laser Therapy) devices cleared on the market for treatment of androgenetic alopecia (including Capillus) are cleared for use on certain skin tones because of the way FDA grants clearances. The FDA gives market clearances based on predicate devices that have been previously approved for the same indication for use (which specifies skin tones as well as extent and type of hair loss) using similar technology. The predicate devices for which all LLLT clearances (which pre-date Capillus) for treatment of androgenetic alopecia have only been approved for skin tones 1-4 on the Fitzpatrick scale.
LLLT at 650 nm and <5mW has never had any reported adverse effects for ANY skin tone, including the darkest of skin tones.
Low-level laser therapy has only been tested on following Fitzpatrick skin types:
- TYPE 1: Highly sensitive, always burns, never tans.
- TYPE 2: Very sun sensitive, burns easily, tans minimally.
- TYPE 3: Sun-sensitive skin, sometimes burns, slowly tans to light brown.
- TYPE 4: Minimally sun sensitive, burns minimally, always tans to moderate brown.
Low level laser therapy has NOT been clinically tested on following Fitzpatrick skin types:
- TYPE 5: Sun-insensitive skin, rarely burns, tans well.
- TYPE 6: Sun insensitive, never burns, deeply pigmented.
About the Fitzpatrick Scale
The Fitzpatrick skin type is a numerical classification for human skin color developed in 1975 by Thomas B. Fitzpatrick. Fitzpatrick skin types are defined by how the skin reacts to the sun. Also known as the Fitzpatrick skin phototype, the Fitzpatrick skin type system was developed in 1975. It remains a useful way to determine skin type and skin cancer risk.
Clinical Testing & Skin Tones
Why have there been no clinical trials on darker skin tones? The protocol used on all clinical trials for LLLT treatment of androgenetic alopecia measured terminal hairs (which are darker and thicker) within an area defined by a tattoo. Because terminal hairs are much more difficult to count within a tattooed area on darker skin tones, these tones have not been tested.
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