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Theradome LLLT Helmet Recruiting Clinical Trial Participants in USA

The manufacturers of a low level laser therapy (LLLT) helmet device which claims to stop hair loss, thicken existing hair and grow new hair are currently recruiting men with Male Pattern Baldness for clinical trials in the US.

According to the trial registration information published on clinicaltrials.gov, the makers of the Theradome Laser Helmet, are hoping to sign up 80 men for the 26-week double-blind trials, during which some of the subjects will use working versions of the helmet while others will receive treatment from a non-working dummy known as a sham device.

Double purpose trial

Theradome Laser Light Therapy Device HelmetThe stated purpose of the trial is to “evaluate the efficacy of low level laser therapy over-the-counter at home device Theradome LH80 PRO, compared to sham for promoting hair growth in males diagnosed with androgenetic alopecia (male pattern baldness), and a usability study to assess subject ability to self-assess hair loss and understanding use of the device.”

In other words, they are hoping to discover not just how effective the device is in combating male and female pattern hair loss, but just how difficult (or easy) is it is to get to grips with, too.

The Theradome Laser Helmet is one of several similar LLLT devices to have sprung up on the market in the past few years, following the success of the original HairMax LaserComb which was first cleared by the FDA in 2007. Recent additions include the iGrow helmet and the LaserCap hat insert, and they have all secured column inches with a number of bold claims.

Impressive claims

Currently priced at $1,020 (including postage from the US) and having gained FDA clearance for treatment of female pattern hair loss, the Theradome’s most impressive claim seems to be that it can prevent genetic hair loss. On the company’s website, the answer to the question – I am 22 and my mother and/or father is bald, can I prevent hair loss? – is as follows: “Yes, it is much easier to prevent hair loss than it is to re-activate any dormant hair follicles. By using our Theradome, you will reverse any potential hair miniaturization. As a result, hair follicles will continue to receive the energy they need through laser light and your hair will keep on growing.”

Belgravia Centre MinoxidilThe helmet was designed by a former NASA scientist and, when worn twice a week for 20 minutes per session, the makers – who have thus far marketed it more at women than men – say its 80 lasers will ultimately lead to cleaner and more manageable hair (after 18-24 weeks) and, after almost two years of use, that users will see “fuller and thicker hair.”

The information they provide seems standard for any LLLT device, although promising ‘cleaner hair’ is an intriguing concept,” advises Leonora Doclis, a Senior Hair Loss Specialist at Belgravia’s Central London clinic, “However, what it does not address is how it deals with the DHT that causes the miniaturisation associated with androgenetic alopecia. If the DHT is not in some way inhibited, then I believe it is unlikely that significant regrowth would be possible – certainly not on a long-term basis given that genetic hair loss is a progressive condition. This is why we recommend using LLLT alongside minoxidil so that it acts as a regrowth booster that complements the action of clinically-proven treatments, rather than being seen as a hair loss treatment in its own right.”

The proposed study, which is scheduled to begin at the start of next year for an August 2016 completion date, will focus on males aged 18-50 whose hair loss currently measures IIa, III vertex, IV and V on the Norwood scale. Trials are set to take place in Georgia. Oregon and Tennessee and we will bring you the results once they are published.

The Belgravia Centre Hair Loss ClinicThe Belgravia Centre

The Belgravia Centre is the leader in hair loss treatment in the UK, with two clinics based in Central London. If you are worried about hair loss you can arrange a free consultation with a hair loss expert or complete our Online Consultation Form from anywhere in the UK or the rest of the world. View our Hair Loss Success Stories, which are the largest collection of such success stories in the world and demonstrate the levels of success that so many of Belgravia’s patients achieve. You can also phone 020 7730 6666 any time for our hair loss helpline or to arrange a free consultation.

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