Low-level laser therapy for the treatment of androgenetic alopecia in Thai men and women: a 24-week, randomized, double-blind, sham device-controlled trial

Abstract

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 24week, 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.

The effectiveness of combination therapies for androgenetic alopecia: A systematic review and meta‐analysis

“…The ability of LLLT to induce vasodilation and increase blood flow has also been reported 40 . It has been confirmed in several placebo‐control trials for therapeutic effects and safety 41‐43 . Esmat et al reported hair regrowth at a deeper dermal level in combination therapy compared to monotherapy, thus inducing hair follicles to anchor more firmly with probable higher sustainability 30 .…”

Examining the Safety and Efficacy of Low-Level Laser Therapy for Male and Female Pattern Hair Loss: A Review of the Literature

“…Suchonwanit et al [26] described the use of the RAMACAP helmet-type LLLT device for treating AGA and FPHL. In this randomized, double-blinded, sham device-controlled study, 36 total subjects including both female patients with Ludwig-Savin Baldness score I–III and male patients with Norwood-Hamilton Baldness scores III–V were treated with either the RAMACAP helmet-type LLLT device or a sham device (10 men and 10 women in each group).…”

“…The treatment with the RAMACAP helmet-type LLLT device resulted in no adverse events, discontinuation, or interruption of the study. Overall, Suchonwanit et al [26] proposed that the RAMACAP helmet-type LLLT device demonstrated the ability to safely improve AGA and FPHL by increasing terminal hair counts and hair diameter.…”

“…Though each study developed their treatment standards, one benefit of this review is that laser parameters and regimens were reported by all but one of the RCTs, so comparisons can be made. Four of the RCTs [17, 18, 24, 26] implemented laser treatment 3 times per week for between 15 and 25 min depending on the study. Another 4 studies [20-22, 25] required treatment every other day for 25 or 30 min.…”

<p>Finasteride and Its Potential for the Treatment of Female Pattern Hair Loss: Evidence to Date</p>

“…6,7 Other treatment options currently available include low-level laser therapy, fractional laser therapy, platelet-rich plasma, human follicle stem cells and hair transplantation. [8][9][10][11][12] Nevertheless, the treatment outcome may not be satisfactory in some patients. Finasteride, an inhibitor of type II 5α-reductase enzyme, is currently indicated for AGA in men.…”