A Systematic Review and Meta-analysis of Randomized Controlled Trials of United States Food and Drug Administration-Approved, Home-use, Low-Level Light/Laser Therapy Devices for Pattern Hair Loss: Device Design and Technology.

BACKGROUND: Low-level light/laser therapy (LLLT) can potentially stimulate hair growth in pattern hair loss (PHL), with many available home-use LLLT devices of different designs and technology on the market. However, not all devices are cleared by the United States (US) Food and Drug Administration (FDA), with very few studies to support their efficacy. OBJECTIVES: This systematic review and meta-analysis aimed to investigate the effectiveness of FDA-approved LLLT devices for PHL treatment. METHODS: We included articles related to FDA-approved home-use LLLT devices on PubMed and Medline, using the FDA 510(K) Premarket Notification database and the systematic search of articles up to January 2020. The standardized mean difference (SMD) for the changes of hair density treated by LLLT versus sham devices was analyzed. RESULTS: Only 32 home-use LLLT devices have been approved by the FDA as of January 2020. The meta-analysis comprised seven double-blinded, randomized, controlled trials. The overall quantitative analysis yielded a significant increase in hair density in those treated by LLLT versus sham groups (SMD: 1.27, 95% confidence interval [CI]: 0.993-1.639). The subgroup analysis demonstrated the increased hair growth in male and female subjects with both comb- and helmet-type devices. There were significant LLLT sources in the LDs alone (SMD: 1.52, 95% CI: 1.16-1.88) and the LDs combination (SMD: 0.85, 95% CI: 0.55-1.16) (p=0.043). CONCLUSION: LLLT is potentially effective for PHL treatment. Nonetheless, the long-term follow-up study in patients with severe PHL with combined standard treatment and comparison between LLLT devices and energy sources is recommended.