Treatment of genetic hair loss with the HairMax LaserComb device using

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

Introduction

Low-Level Laser Therapy (LLLT) has gained significant attention in recent years due to its potential to stimulate hair growth without the need for chemotherapy or surgery. This randomized, double-blind, sham device-controlled trial was conducted to evaluate the efficacy and safety of the HairMax LaserComb device in the treatment of androgenetic alopecia (AGA).

Method of study

Participants: 123 men aged 30–60 years diagnosed with AGA grade IIa–V according to the Norwood–Hamilton criteria.
Duration: 26 weeks (6 months)
Treatment: Use either the HairMax LaserComb device (655 nm wavelength) or a sham device (no laser).
Frequency: 3 times a week, 15 minutes each time.
Evaluation:

Hair density was measured using macroimaging and computer-aided hair counts.
Evaluate the satisfaction of users and examining physicians.

Study results

🔹 Efficiency in increasing the number of hairs

The group using the HairMax LaserComb had an average increase in hair count of +19.8 strands/cm².
While the sham group had an average hair loss of –7.6 strands/cm².
The results were statistically significant (p < 0.0001).

🔹 User and physician evaluation

Participants in the HairMax group reported thicker, stronger hair and improved scalp health (p < 0.05).
86% of HairMax users saw a hair growth of more than 5 strands/cm².
Only 2.8 percent had a decrease in hair volume.

🔹 Safety

No serious side effects were found.
Minor symptoms include a warm feeling, itchy scalp, or numbness in a small area, which resolves on its own.
There was no statistical difference in side effects between the experimental and control groups.

Mechanism of action

Low-energy laser light 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 flow and oxygen transport to the hair roots.
Stimulates the division of cells in the hair root (matrix cells), causing new and thicker hair to grow.
Prevention of hair root miniaturization, the main mechanism of genetic hair loss.

Summary of results

From the research of 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 US Food and Drug Administration (FDA). For the treatment of male genetic hair loss
Suitable for those who want a safe, drug-free, and non-surgical treatment.

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.