REVIAN Inc. (formerly PhotonMD Inc.) – a medical technology company dedicated to stimulating the body’s natural processes to rejuvenate hair and skin with light – is excited to announce that final data from a randomized, double-blind study of the REVIAN RED hair growth system was presented at the 2020 Winter Clinical Dermatology Conference – Hawaii®. The data is now available on the REVIAN website following presentation at the conference. In this clinical trial, REVIAN RED successfully demonstrated the ability to stop hair loss and subsequently grow new hair.

“The final data is over 20% greater than the top-line data reported in September 2019,” said Brian Johnson, President of REVIAN Inc. “Higher amounts of hair growth in the first 4 months, discovery of the statistically significant reduction of scalp itch, and more positive safety results for light therapy proves that REVIAN RED can redefine what is possible from an at-home hair loss treatment.”

Androgenetic alopecia, or pattern hair loss, affects approximately 50 million men and 30 million women suffering with hair loss in the United States.1 Male pattern hair loss is typically characterized by a receding hair line or balding of the crown, and female pattern hair loss appears as overall thinning or widening of the midline. Both men and women frequently suffer from scalp irritation and itch, establishing a need for treatments that improve overall scalp health.

Adult men and women diagnosed with androgenetic alopecia were randomly assigned to a dual wavelength, all-LED hair growth cap (REVIAN RED) or placebo cap (with no light therapy) for 10-minutes per day. Final results showed a mean improvement of 26.3 hairs/cm2 over the placebo cap among participants who were at least 80% compliant with the treatment protocol. Preliminary results had shown that participants assigned REVIAN RED had an average of 21.3 more hairs/cm2.

“We specifically designed this clinical trial with the rigor of a pharmaceutical trial,” said Rodney Sinclair, MD, professor of medicine at Melbourne University and principal investigator in the trial. “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.”

As a part of the study, a quality-of-life questionnaire was used to assess itching, burning and stinging, irritation, and other patient-reported outcomes. Participants scored each question on a scale from 1 (never) to 5 (all the time). Statistically significant reductions were observed in patient-reported pruritus (itch) and burning/stinging compared to sham after 16 weeks of once-daily, at-home treatment.

“Scalp symptoms such as pruritus, burning, and irritation are extremely common complaints in the dermatological setting and can be frustrating for both the patient and dermatologist alike,” stated Dr. Mark S. Nestor, Director of the Center for Clinical and Cosmetic Research and a Voluntary Professor at the Phillip Frost Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine. “The clinical data showing significant reduction in itching, burning, and irritation observed with this new class of LED light therapy that utilizes two wavelengths of light is extremely encouraging.”

The mechanisms of action for improved scalp symptoms are proposed to be the anti-inflammatory effects of nitric oxide (NO) released with the patented dual wavelength light. REVIAN Inc. is unaware of any previous reports of a reduction in “itchy scalp” with traditional single-color laser-based devices used to treat androgenetic alopecia.

The dual wavelength, all-LED REVIAN RED device demonstrated excellent safety. During the trial, there were no treatment discontinuations due to an adverse event and there were no device-related serious adverse events reported for any treatment arm.

Source: Company Press Release