Introduction
Androgenetic alopecia (AGA) is a common condition in both men and women, caused by follicular miniaturization, which is associated with androgen hormones. Commonly used treatments, such as minoxidil and finasteride, have limited efficacy and side effects. This study aimed to evaluate the effectiveness and safety of the HairMax LaserComb, an FDA -cleared low-level laser therapy (LLLT) device, for the treatment of AGA in both genders.
Method of study
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Study design: Randomized, double-blind, multicenter RCT.
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Number of participants:
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128 men and 141 women (total 269 people)
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Age 25–60 years
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Duration: 26 weeks
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Devices used: HairMax LaserComb 7-beam, 9-beam, and 12-beam models (wavelengths 635–655 nm).
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Frequency of use: 3 times a week, covering the entire head (8–15 minutes per session, depending on the model).
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Measurement:
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Number of hairs per area (terminal hair density, hairs/cm²)
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User assessment (self-assessment)
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Adverse Reaction Reporting
Study results
Efficiency in increasing hair growth
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All groups using the HairMax LaserComb had a significant increase in hair count compared to the control group.
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Average hair growth at 26 weeks :
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Female 9-beam: +20.2 lines/cm²
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Female 12-beam: +20.6 lines/cm²
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7-beam male: +18.4 lines/cm²
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9–12-beam male: +20.9 to +25.7 lines/cm²
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Sham group: increased only +1.6 to +3.0 lines/cm².
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All results were statistically significant (p < 0.001).
User evaluation
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60–80 percent of users report thicker hair and less hair loss.
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Users report satisfaction with improved hair condition and scalp health.
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Results are independent of gender, age, or device model.
safety
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No serious side effects were found.
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Minor symptoms such as dry skin, itching, or a warm sensation on the scalp (≤5%) that resolve on their own.
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No participants had to stop using the device due to side effects.
Mechanism of action
Low-energy laser light therapy stimulates hair follicle cell activity by:
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Increases ATP and energy production in mitochondria
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Stimulates the division of hair root cells (matrix cells)
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Stimulates hair roots to enter the anagen phase.
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Reduces cellular inflammation and reduces hair root atrophy.
Summary of results
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With continuous use of the HairMax LaserComb for 26 weeks, significant hair growth was observed in both men and women.
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It is highly safe, with no serious side effects.
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The effectiveness is similar to that of short-term use of Minoxidil 5% or Finasteride 1 mg.
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It is an alternative that does not require medication, surgery, and is convenient to use at home.
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




