530 A clinical comparison of photobiomodulation devices for the treatment of alopecia in all skin types

Photobiomodulation (PBM) therapy is an emerging treatment for androgenetic alopecia (AGA). Although various devices are FDA-cleared for treatment (skin types I-IV only); no known trials to date have directly compared their outcomes against one another. Furthermore, these devices have not been studied in skin types of V-VI. We aim to clinically compare and evaluate the use of 4 FDA-cleared PBM devices in treating subjects of all skin types diagnosed with AGA. Subjects of skin types I-IV with AGA were randomized to PBM devices and received treatments per manufacturer's recommendations. Photographs of the scalp were obtained at baseline and then each subsequent month using Canfield Capture system. Self-assessment questionnaires were administered monthly throughout the study. This study first enrolled 14 pilot subjects, 11 were randomized among 6 devices for 3 months of treatment, had sufficient data to analyze their progress. 62.50% of subjects had improvements as assessed by physician scalp exams. However, at the end of the study, 45% of subjects remained dissatisfied with treatment. Based on this pilot group, the study was lengthened to 4 months of treatment and subjects randomized to 4 devices (the 2 devices most challenging to use were not used in the second part of this study). In this second part of this study, patients with skin types V and VI were also enrolled to investigate the efficacy of PBM devices on darker skin types. To date, 30 subjects have been enrolled in this study, of which 11 are skin types V and VI. 8 of skin types I-IV and 1 of skin type V successfully completed the study so far. Based on the scalp exams and photographs, improvements varied across all devices and skin types. Data obtained from the first part of this study demonstrate variable improvement in hair grading scales from scalp exams as well as variable responses on self-assessments. Therefore, greater patient numbers and continued enrollment is needed of all skin types.