Randomized therapy for hereditary hair thinning with the HairMax Laser

(Randomized Controlled Trial: Leavitt et al., 2009)

Introduction

Low-Level Laser Therapy (LLLT) has garnered significant attention in recent years due to its potential to stimulate hair growth without the need for chemical drugs or surgery. This research is a randomized, double-blind, sham device-controlled trial to evaluate the efficacy and safety of the HairMax LaserComb in treating androgenetic alopecia (AGA) in males.

Methods

Participants: 123 men aged 30–60 years diagnosed with AGA grades IIa–V according to the Norwood–Hamilton scale.
Duration: 26 weeks (6 months)
Treatment: Using the HairMax LaserComb (wavelength 655 nm) or a sham device (no laser light).
Frequency: 3 times per week, 15 minutes per session.
Outcome Measures:

Hair density measured by macroimaging and computer-aided hair counts.
Assessment of user and investigator satisfaction.

Results

🔹 Efficacy in Increasing Hair Count

The HairMax LaserComb group showed an average increase of +19.8 hairs/cm².
The sham device group showed an average decrease of –7.6 hairs/cm².
The results were statistically significant (p < 0.0001).

🔹 User and Physician Assessment

Participants in the HairMax group reported thicker, stronger hair and improved scalp health (p < 0.05).
86% of HairMax users experienced a hair count increase of more than 5 hairs/cm².
Only 2.8% experienced a decrease in hair count.

🔹 Safety

No serious adverse effects were found.
Minor symptoms, such as warmth, scalp itching, or slight numbness, were self-resolving.
There was no statistically significant difference in adverse effects between the experimental and control groups.

Mechanism of Action

Low-level laser irradiation at a wavelength of 655 nm can stimulate biological processes at the cellular level, including:

Stimulating mitochondria to produce more energy (ATP).
Increasing blood circulation and oxygen delivery to the hair follicles.
Stimulating the division of hair follicle matrix cells, leading to new and thicker hair growth.
Preventing follicular miniaturization, which is a primary mechanism of androgenetic hair loss.

Conclusion

From the research by Leavitt et al. (2009), it was found that:

The HairMax LaserComb is a highly effective and safe LLLT device.
It can significantly increase hair density within 26 weeks.
It is the first device to be approved by the U.S. Food and Drug Administration (FDA) for the treatment of androgenetic alopecia in males.
It is suitable for individuals seeking a safe, drug-free, and non-surgical treatment approach.

References

Leavitt M., Charles G., Heyman E., Michaels D. (2009). HairMax LaserComb Laser Phototherapy Device in the Treatment of Male Androgenetic Alopecia: A Randomized, Double-Blind, Sham Device-Controlled, Multicentre Trial. Clinical Drug Investigation, 29(5): 283–292.