REVIAN Inc. releases data from their investigational study examining their REVIAN RED dual wavelength LED light treatment for androgenetic alopecia, showing the FDA-cleared device to be both safe and effective at week 16 in a 26-week trial.
A low-level light therapy device may be a safe and effective alternative to other treatments for androgenic alopecia, according to recently published data from REVIAN, Inc.
The study was designed to investigate the efficacy of the company’s REVIAN RED light treatment for androgenetic alopecia. REVIAN Red is an LED dual wavelength device that utilizes low-level light therapy to reduce hair loss and promote growth.
The multicenter, prospective, randomized, double-blind, controlled study enrolled 81 adult patients who had been diagnosed with androgenetic alopecia. Participants ranged in age from 18 to 65 years. The participants included women with Ludwig-Savin Scale I-1 to I-4 patterns of hair loss and men with Norwood Hamilton Classification IIA-V, while both having I-IV Fitzpatrick Skin Types.
Researchers randomized the subjects into two treatment arms: 39 individuals received treatment with the REVIAN RED device, while 42 people were treated with a sham device. Both arms also utilized mobile apps to help researchers track daily treatment compliance.
During the study, both groups used their devices for 10 minutes daily over 26 weeks. A total of 90% of patients in the REVIAN RED group and 88% of those in the sham group completed the study.
The primary endpoint included the mean change in target area hair count between active and sham-treated patients at week 16.
“We specifically designed this clinical trial with the rigor of a pharmaceutical trial,” says Rodney Sinclair, M.D., lead study investigator and professor of medicine at Melbourne University. “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.”
Primary endpoint data was collected for total hair count by a computer-assisted scan of digital photos of a tattoo located in the anterior mid area of the scalp.
The results, which were initially presented at the 2020 Winter Clinical Dermatology Conference in Hawaii, show following 16 weeks, patients who were a minimum of 80% treatment compliant (n=18) has a mean change of 26.3 more hairs per cm2 in comparison to the patients given placebo, (n=18).1
Previously reported results displayed a mean of 21.3 more hairs per cm2 in individuals given REVIAN RED.2
The most common adverse events included upper respiratory tract infections and headache; with pruritus, dandruff, burning, and rash pruritic being treatment related adverse events.
“The final data is over 20% greater than the top-line data reported in September 2019,” says Brian Johnson, president of REVIAN Inc, in a press release. “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.”
The REVIAN RED dual wavelength device is currently U.S. Food and Drug Administration-cleared.
1 Sinclair R, Murrell D, Spelman L, et al. Clinical Safety and Efficacy of an At-Home, Dual Wavelength Red Light Hair Growth System in Subjects with Androgenetic Alopecia. https://16opuq2589oi2u1we332yms1-wpengine.netdna-ssl.com/wp-content/uploads/2020/01/Clinical-Efficacy-At-Home-Dual-Wavelength-Red-Light-Hair-Growth-System-Subjects-With-Androgenetic-Alopecia.pdf. Published January 21, 2020. Accessed April 1, 2020.
2 REVIAN® Presents Leading Clinical Trial Results for New Hair Loss Treatment. Business Wire. https://www.businesswire.com/news/home/20200121005292/en/REVIAN®-Presents-Leading-Clinical-Trial-Results-New. Published January 21, 2020. Accessed April 1, 2020.