Although results have not yet been published, its trial registration data confirmed on 15th July that the study was finalised on 25th May 2019.
The Phase 3 trial was conducted by PhotonMD using three different versions of a hair loss device called the REVIAN System and one non-active device used as a placebo for control purposes.
Each participant used their randomly allocated cap-style device for 10 minutes per day for a total of 26 weeks.
Hoping to determine the devices' safety and efficacy in aiding hair regrowth in cases of Male Pattern Baldness graded between Norwood Hamilton Classifications IIa and V, patients were assessed at week 8, week 16 and week 26.
Both macro research photos and those taken by the participants of the areas of hair loss being treated were examined. In addition, at each appointment, all participants were required to complete a questionnaire relating to how they felt about their hair regrowth progress, and another regarding their quality of life.
All 161 participants were aged 18 to 65 years, with no history of finasteride 1mg use for the past 12 months, nor any high strength minoxidil use for the past 6 months. These are currently the only MHRA-licensed and FDA-approved medications for treating genetic hair loss in men.
Previous hair transplant recipients, those with Alopecia Areata or scarring on their scalp, and those who have used PRP, microneedling or micropigmentation to address their hairloss were ruled ineligible for the study.
Although the initial requirements suggested this clinical trial was also open to women with Female Pattern Hair Loss, the information now suggests it concentrated solely on men.
The REVIAN System disperses a trademarked treatment known as modulated light therapy (MLT).
The three different devices being explored emit the following wavelengths of light in nanometres (nm): REVIAN device 101 delivers 625 nm and 660 nm of red light; 102 delivers 425 nm of blue light; 103 delivers 425 nm of blue light and 625 nm and 660 nm of red light.
Blue light therapy is generally used to treat skin disorders, including acne, and improve skin texture, whilst red light therapy is also used to treat skin issues, such as scarring, as well as seasonal affective disorder.
Red light therapy is already used in popular FDA-cleared hair growth devices from a number of companies, most notably HairMax. HairMax was the first to receive this authorisation from the American medical regulator for a home-use product of this kind, with its patented LaserComb device gaining clearance in January 2007.
Since then it has refined and improved its low-level laser therapy (LLLT) technology, offering headband- and cap-style devices designed to be used for a few minutes around three times per week.
The company claims its data shows the devices can actively promote hair growth and encourage thicker, stronger hair.
A 2017 systematic review of hair loss treatments found that the only three that worked - all of which can be used together as part of a tailored male hair loss treatment course - were finasteride 1mg, minoxidil and LLLT.
Whether this new REVIAN System proves to be the next generation of light therapy for hair loss remains to be seen but we will publish the results here on the Belgravia blog as soon as they are made available.
The Belgravia Centre is a world-renowned group of a hair loss clinic in Central London, UK. If you are worried about hair loss you can arrange a free consultation with a hair loss expert or complete our Online Consultation from anywhere in the world for home-use treatment.
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