Hello Dr Rassman.
I have a slight bone to pick with you, regarding some interesting comments made about the Lasercomb. In one of your articles you mentioned the line “I still go by my gut feeling, an application three times a day by a comb going through the hair just does not sit right with me and my intellectual judgment (which dictates a great deal about why I think that way)”. I would like to point out the ridiculous parallels of this comment to a certain other product called Rogaine. Firstly no one actually knows how Rogaine works (the company readily admits this on there website) Secondly I dont think its any more absurd or outrageous to think a comb with lazers is any less effective than putting an alcohol like solution called “Roagine” which no one really knows ingredients of and how and why it really works on your head everyday. Or for that matter Propecia. They all take an element of FAITH! But at least the lasers have a basic theory of stimulation of the hair follicle. How the hell does alcohol going to do any better?
To answer to your question, I need to explain a bit about medical research, which could be found behind almost any new treatment modality in medicine. Any new drug needs to go through different phases of testing before becoming approved for use in humans. The LaserComb did not go through such testing, but rather got FDA approval because other such devices were approved in the past (predicate device).
New treatment modality first needs to go through preclinical testing, which involves using new treatments in the lab, including cell cultures followed by its use in animals for its efficacy and safety evaluation. If it proves safe and effective in animals, a clinical trial follows.
Clinical trial is the direct application of a new drug on humans and has four phases:
- Phase one is the first stage of testing drug in a small group of volunteers. This phase is done to prove safety and tolerability of drug.
- Phase two is performed on larger groups of patients to assess the efficacy of the new treatment and its possible side effects. This phase usually last a few years.
- Phase three is a randomized controlled trial on larger groups of patients (a few hundreds to thousands of subjects). It is done to define the value of a new treatment in comparison with other available treatment options. If medication passes this phase it could be offered for its general use.
- Phase four is performed on a longer period of time, and involves post-launch safety evaluations, long term adverse effects and technical support of a drug.
Minoxidil is a medication that was initially used for the treatment of high blood pressure. This medication was first studied for one of its side effects, “increase of hair growth†in the early 80s. After its effectiveness for treatment of androgenetic alopecia was confirmed by initial studies, it was studied on cell cultures, animals, and humans in different concentrations. Several research centers and universities studied the effectiveness of this medication and its comparison with other modalities. Since the experiments in the early 80s, minoxidil was first suggested for its use for treatment of androgenetic alopecia. It has been studied for different groups, sexes, ages, and races. Numerous research projects directly evaluated the effectiveness of minoxidil since early 80s. The result of these studies is over 100 articles that are published in major peer reviewed medical journals.
Although the application of laser for treatment of baldness sounds glorious, so far there is no reliable research papers in peer reviewed journals to prove its effectiveness for hair loss treatment. A physician, unlike a sales person, needs to see solid based research published in peer reviewed medical journals before being able to use or recommend a new treatment modality. For the LaserComb, none is available at this time.
Tags: hairmax, lasercomb, laser comb, hairloss, hair loss, fda, rogaine, minoxidil