HairMax LaserComb treatment for androgenetic alopecia in males and females (Jimenez et al., 2014)

Introduction

Androgenetic Alopecia (AGA) is a common problem in both men and women, caused by follicular miniaturization, which is associated with androgen hormones. Common treatments such as Minoxidil and Finasteride have limitations in terms of efficacy and side effects. This research aims to evaluate the efficacy and safety of HairMax LaserComb, a Low-Level Laser Therapy (LLLT) device approved by the FDA for treating AGA in both sexes.

Study Methods

• Study Design: A sham device-controlled, double-blind, multicenter, randomized controlled trial (RCT)

• Number of Participants:

• 128 men and 141 women (total 269)

• Aged 25–60 years

• Duration: 26 weeks

• Device Used: HairMax LaserComb 7-beam, 9-beam, and 12-beam models (wavelength 635–655 nm)

• Frequency of Use: 3 times per week, covering the entire scalp (8–15 minutes per session, depending on the model)

• Measurements:

• Terminal hair density (hairs/cm²)

• User self-assessment

• Adverse event reporting

Results

Efficacy in Increasing Hair Count

• All HairMax LaserComb groups showed a significant increase in hair count compared to the control group.

• Average increase in hair count at 26 weeks:

• Women 9-beam: +20.2 hairs/cm²

• Women 12-beam: +20.6 hairs/cm²

• Men 7-beam: +18.4 hairs/cm²

• Men 9–12-beam: +20.9 to +25.7 hairs/cm²

• Sham group: Increased by only +1.6 to +3.0 hairs/cm²

• All results were statistically significant (p < 0.001)

User Self-Assessment

• 60–80% of users reported thicker hair and reduced shedding

• Users reported improved satisfaction with hair condition and scalp health.

• Results were independent of sex, age, or device model.

Safety

• No serious side effects were observed.

• Minor symptoms reported, such as dry skin, itching, or warmth on the scalp (≤5%), resolved spontaneously.

• No participant discontinued the device due to side effects.

Mechanism of Action

Low-level laser irradiation stimulates hair follicle activity by:

• Increasing ATP production and mitochondrial energy

• Stimulating cell division of hair follicles (matrix cells)

• Promoting hair follicles to enter the anagen phase

• Reducing cellular inflammation and follicular miniaturization

Conclusion

• Consistent use of HairMax LaserComb for 26 weeks significantly increased hair count in both men and women.

• It is highly safe, with no serious side effects observed.

• Efficacy is comparable to Minoxidil 5% or Finasteride 1 mg in the short term.

• It is a drug-free, non-surgical, and convenient at-home treatment option.

References

Jimenez, J. J., Wikramanayake, T. C., Bergfeld, W., Hordinsky, M., Hickman, J. G., Hamblin, M. R., & Schachner, L. A. (2014). Efficacy and safety of a low-level laser device in the treatment of male and female pattern hair loss: A multicenter, randomized, sham device-controlled, double-blind study. American Journal of Clinical Dermatology, 15(2), 115–127. https://doi.org/10.1007/s40257-013-0060-6