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LaserComb Receives FDA Clearance for Female Pattern Hair Loss

HairMax LaserComb FDA cleared for womenThe US Food and Drug Administration (FDA), the official body responsible for regulating medical treatments and devices in America, has given Marketing Clearance to a new LaserComb to treat Female Pattern Hair Loss.

The device, the HairMax LaserComb Lux 9, is manufactured by Florida-based Lexington International, who have a long history of supplying laser combs for the treatment of hair loss around the world. The Belgravia Centre offers the company’s LaserComb PRO 12 and LaserComb Premium as standard with many of our treatment courses.

What makes the Lux 9 model different is that it is the first device to be cleared by the FDA for the treatment of Female Pattern Hair Loss in women suffering from Ludwig\ Savin patterns of hair loss defined as I-1, II-1, II-2 and frontal hair loss.

This new FDA clearance is significant because it is not merely a measure of the device’s safety but also its effectiveness in treating women with hair loss.

Double-blind study

According to Lexington International, the device has been clinically proven using a double-blind device-controlled study. In clinical trials across five locations in the US, subjects were treated with either the HairMax Lux 9 or a ‘control device’, with neither the subjects nor the investigators being aware of which device was being used. The results showed that all subjects who used the Lux 9 experienced hair re-growth within six months, at a medically significant rate of 20.5 hairs per cm².

Lexington’s Managing Director, David Michaels, commented: “With this FDA clearance for the treatment of females with pattern hair loss, the Hair Max will now offer effective relief and enrich the lives for all people with Hereditary Hair Loss regardless of gender.”

The LaserComb uses low-level laser light to “stimulate dormant and active hair follicles”. When used on the scalp, this laser energy penetrates the hair follicles and increases the action of adenosine triphosphate (ATP), an important substance in the body responsible for carrying energy to living cells. This in turn results in increased hair production.

What is Female Pattern Hair Loss?

Female Pattern Hair Loss is, like Male Pattern Baldness, a form of genetic hair loss. It is the most common form of hair loss experienced by women, and it is estimated that tens of thousands of women in the UK suffer from it.

Unlike Male Pattern Baldness, where the sufferer experiences baldness, bald patches and/or a receding hair line, Female Pattern Hair Loss usually results in diffuse thinning of the hair spread across the crown. Research suggests that by the age of 50, half of all women will experience some amount of hair loss due to Female Pattern Hair Loss.

Lexington’s Medical Advisor, Dr. Matt Leavitt, commented: “Hair loss amongst women is a growing concern. In the past, women only had one FDA Approved drug ingredient to treat their hair loss. Now they have a clinically proven viable alternative. I believe the HairMax will be able to offer help to the millions of women suffering from hair loss.”

A supplemental treatment, not an alternative

The drug Dr. Leavitt is referring to is Minoxidil, a pharmaceutical treatment which has been FDA approved in the US for the treatment of genetic hair loss in men and women, and is licensed in the UK by the Medicines and Healthcare Products Regulatory Agency (MHRA). Minoxidil is one of the core treatments used by The Belgravia Centre in the treatment of many hair loss conditions.

Far from being an alternative to treatment with Minoxidil and other pharmaceutical products, we believe that this new laser comb is another tool to be used in conjunction with other hair loss treatments. Optimal hair re-growth and prevention of hair loss can be achieved through a holistic approach which utilises all the available options for treatment.

The Belgravia Centre – Experts in the Treatment of Hair Loss

At the Belgravia Centre, we use the LaserComb as just one part of a wider treatment programme. Our hair loss experts have successfully treated many cases of Female Pattern Hair Loss, Male Pattern Baldness and other hair loss conditions such as Alopecia Areata. Each treatment course is tailored to the individual, and may involve pharmaceutical treatments such as Minoxidil, Propecia (in the case of men), LaserCombs, and nutritional supplements.

For more information on how we can treat your hair loss, contact us today for a free consultation, or fill in our online diagnostic form for a home-use treatment programme that we can post anywhere in the world.

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