PhotonMD Inc. announced positive results of a clinical trial assessing Revian Red, an all-LED cap for the treatment of androgenic alopecia vs. a series of other hair growth devices.
In the randomized, double-blind, placebo-controlled trial, Revian Red demonstrated the ability to stop hair loss and subsequently grow new hair, according to a press release.
Adult patients diagnosed with androgenetic alopecia were randomly assigned to a light-based hair growth treatment or placebo cap with no light therapy for 10 minutes per day of use for up to 26 weeks. Participants agreed to cease using all other hair growth products or treatments during the study period.
Target area hair count defined the primary endpoint in both participant groups at week 16. Hair counts were obtained via computer-assisted scans of digital photographs of a defined target area of 1 cm2 centered on a tattoo located in the anterior mid area of the scalp, according to the release.
Among participants who were at least 80% compliant with the treatment protocol, the 18 participants assigned red light therapy had an average of 21.3 more hairs per cm2 compared with baseline and the 18 participants who wore a placebo cap but received no light therapy.
Those treated with the placebo cap continued to lose hair during the study duration.
There were no treatment discontinuations due to an adverse event and no device-related serious adverse events.
In February 2018, the company received FDA 510(k) clearance for the device.
“We specifically designed this clinical trial with the rigor of a pharmaceutical trial,” Rodney Sinclair, MD, professor of medicine at Melbourne University and principal investigator in the trial, said in the release. “We used the same primary and secondary endpoints as were used in [the] finasteride and minoxidil studies. We used placebo caps. Participants and evaluators were blinded, and as an outcome, these results can be trusted.”