Androgenetic Alopecia Clinical Trial
Official title:
Evaluation of the GENIX, a Low Level Light Device as a Primary Therapy for Androgenetic Alopecia in Men and Women
The purpose of this research is to study the safety and effectiveness of a light therapy device for human hair growth. This device, called the GENIX, is a type of cold, or non-heat producing light emitting diode (LED) that will emit light on the hair growth cells within and around the hair follicle. When these cells do not function properly, one may experience common problems such as baldness and thinning or brittle hair. The application of a special category of low-level non-laser light to be studied in the project may cause an increase in essential nutrients to the damaged hair follicles and skin cells, leading to a reduction in hair loss and in some cases, possibly leading to re-growth.
The application of low-level light therapy has aroused considerable research interest in
recent years for the treatment of a variety of clinical indications. These range from pain
management to wound healing and most recently to hair regrowth. All have demonstrated
biological effects in living organisms. In 1967 Endre Mester, a physician practicing in
Budapest Hungary, decided to test the effects of laser radiation on mice and its possible
link to resultant cancer. To his great surprise, the mice regrew the shaved hair in half the
time of non-radiated mice. This was the first reference to LLLT and hair growth.
This study on LLLT, aims to confirm the established safety and physiologic effects that occur
when the human hair follicle and surrounding tissue structures are exposed to this type of
radiation. Thus far, all reports on the efficacy of low level light therapy (LED) in this
area, have been, in large part, consistent in outcome results, as supported by multi-center,
randomized, double blind, controlled studies. This has been in the form of analysis of the
non-radiated and radiated tissues as determined by terminal hair counts from baseline to post
treatment counts. The theory that is widely accepted is that the mitochondria are the
powerhouse of the stem cells that cause hair growth. The LLLT "turns on" the nutrient pump
process that energizes the mitochondria, which leads to an increase in ATP and subsequent
reversal of hair follicles from the dormant stage of growth called telogen, to the active
growth stage called anagen.
This specific light system is unclassified by the FDA, from a radiation standpoint, because
the agency has not developed class designations for LEDs. Currently, it is classified as a
class II medical device and will be designated as an Over-the-Counter device. It may be
marketed for hair regrowth, as defined by an increase in terminal hairs and wellness, which
can be defined as thicker, denser, more supple and darker hair shafts.
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