The aesthetic medical technology company announced that its hair regrowth system will be used in a second study.
The device is a wireless cap that uses dual wavelength LED technology and is controlled by a mobile app. The system uses a dual-combination of 2 LED wavelengths to “stimulate the production and release of nitric oxide, proven to increase local blood flow, reduce inflammation, and inhibit DHT production which provides the right environment for new hair growth,” according to an earlier press release.2 The RED Hair Regrowth System is currently the first and only all-LED hair loss device cleared by the US Food and Drug Administration (FDA) for hair regrowth.
The results of the first study of the device in patients with central centrifugal cicatricial alopecia (CCCA) were presented at the 2022 Society for Investigative Dermatology Annual Meeting. To the knowledge of researchers, it was the first study to evaluate the efficacy of low-level light therapy to address treatment and management of CCCA.3
As a result of the study, researchers reported that 75% of patients had improved Dermatology Life Quality Index scores from baseline to conclusion. Furthermore, 75% of patients achieved a decrease in follicular openings.3
The second study will include adult participants between the ages of 18 and 65 with a diagnosis of CCCA. The diagnosis should be confirmed with either a biopsy or trichoscopy in order for patients to participate. Researchers hope to investigate the efficacy and safety of the RED Hair Growth System in treating patients with clinical CCCA, aiming for the device to decrease inflammation or bring hair follicles back to anagen growth.
Participants will be asked to use the device for 10 minutes daily for a period of 6 months.
"While we do not know the exact cause of CCCA, we do know that inflammation is a major factor in how this form of alopecia develops,” said Amy McMichael, MD, in the press release. McMichael is chair and professor of dermatology at Wake Forest University School of Medicine and conducted the initial study.
“We hope to demonstrate the Revian RED system can improve scalp symptoms, reduce hair loss, and promote maturation of vellus and intermediate hairs in non-scarred areas of the scalp in those affected by CCCA,” McMichael said.
Study co-investigator Ivie Obeime, MD, DO, FAAD, is a research fellow in the Wake Forest School of Medicine’s Department of Dermatology. Obeime said she is hopeful the study will demonstrate the device’s efficacy in combination with other anti-inflammatory therapies.
"It would be of great benefit to determine if there is any advantage in using the Revian RED system along with other anti-inflammatory therapies to relieve symptoms or promote hair regrowth in follicles that have not yet become scarred," Obeime said in the press release.
Researchers are hopeful that this second trial will lead to a larger clinical trial in the future.