Low-level laser/light therapy (LLLT) has been increasingly used for promoting hair growth in androgenetic alopecia (AGA). Our institute developed a new home-use LLLT device, RAMACAP, with optimal penetrating energy, aiming to improve therapeutic efficacy and compliance. To evaluate the efficacy and safety of the new helmet-type LLLT device in the treatment of AGA, a 24-week, prospective, randomized, double-blind, sham device-controlled clinical trial was conducted. Forty subjects with AGA (20 men and 20 women) were randomized to treat with a laser helmet (RAMACAP) or a sham helmet in the home-based setting for 24 weeks. Hair density, hair diameter, and adverse events were evaluated at baseline and at weeks 8, 16, and 24. Global photographic assessment for hair regrowth after 24 weeks of treatment was performed by investigators and subjects. Thirty-six subjects (19 in the laser group and 17 in the sham group) completed the study. At week 24, the laser helmet was significantly superior to the sham device for increasing hair density and hair diameter (p = 0.002 and p = 0.009, respectively) and showed a significantly greater improvement in global photographic assessment by investigators and subjects. Reported side effects included temporary hair shedding and scalp pruritus. In conclusion, the novel helmet-type LLLT device appears to be an effective treatment option for AGA in both male and female patients with minimal adverse effects. However, the limitations of this study are small sample size, no long-term follow-up data, and use of inappropriate sham devices, which do not reflect the true negative control. Trial registration: http://clinicaltrials.in.th/index.php?tp=regtrials&menu=trialsearch&smenu=fulltext&task=search&task2=view1&id=2061 , identifier TCTR20160910003.
Keywords: Androgenetic alopecia; Female pattern hair loss; Low-level laser therapy; Low-level light therapy; Photobiomodulation.