Exclusive interview with Dr. Brotzu for Bellicapelli

Here is an exclusive interview with Dr. Brotzu for Bellicapelli. Following are the questions we asked and all his answers.

Good Morning Dr. Brotzu,

In your opinion what are the expectations an individual suffering from Androgenetic Alopecia should have towards your product? Do you think this product has the potential to eliminate the problem of Androgenetic Alopecia? Considering the trials you carried out and your opinion, to what extent can areas characterized by Androgenetic Alopecia, with miniaturized hair or even vellus, improve? Brotzu, in case of Androgenetic Alopecia, does the therapy have to last forever or it can be suspended or even completely stopped? Considering your trials and your experience, what individuals suffering from Androgenetic Alopecia responded better to the therapy as far as gender and age are concerned? Considering your trials and experience, what individuals suffering from Alopecia Areata responded better to the therapy as far as gender and age are concerned? Can you foresee or even just hypothesize an approximate date for the commercialization of the drug? How will the experimentation carried out by Fidia be organized? Brotzu, to date we have had the opportunity to see only photos of Alopecia Areata cases. Since statistically the number of individuals suffering from Androgenetic Alopecia is considerably higher compared to that of individuals suffering from Alopecia Areata, would it be possible to know if there is any photographic material available also for this pathology? In case there is not, could you explain the reason why? The lotion will be composed of: dihomo-gamma-linolenic acid (dgla), carnitine, s-equol, carried into cationic liposomes. Among these components – dgla, equol, carnitine, cationic liposomes – (excluding of course their interaction), which one is, according to you, the real strength of your discovery? Brotzu, considering your trials and the experience you gained, how would each component (dgla, equol, carnitine) affect the miniaturization process that characterizes Androgenetic Alopecia? Was the formulation effective against Androgenetic Alopecia also without equol (that you supposedly added on a later stage)? Since equol is an anti-dht and since Alopecia Areata doesn’t have any androgenetic origin, do you think that equol was added because PGE1 by itself (or as an alternative its precursor DGLA) was not effective in case of Androgenetic Alopecia? Brotzu, your tests were carried out both using PGE1 and its precursor, that is DGLA. Did you notice any substantial difference in the results concerning Androgenetic Alopecia? Did you observe any side effects and in case you did, what kind of side effects? Do you think there is a good chance that the product will be commercialized? Do you think there is any reason that could prevent the commercialization and if you do, why? Brotzu, do you think your product can be improved in the future? Brotzu, will the lotions be different according to the typology of Alopecia the patient is suffering from (AGA or AA) because of equol that will carry out its anti-dht action? Brotzu, what differentiates our product from any other anti-dht topical product? Brotzu, according to your direct and indirect experience, can the skin of the recipient area of a patient who underwent a hair transplant benefit from your discovery (thus leading to a hair growth), or on the other hand the follicles experienced excessive damages during the transplant and cannot therefore be recovered?

FOLLOWING ARE THE ANSWERS DR. BROTZU GAVE TO OUR QUESTIONS

The answer to your questions is complex and it is therefore almost impossible to answer each and every question singularly.

First of all, I want to clarify the mechanism of the lotion and its principles.

Alopecia (androgenetic, areata and totalis) is characterized by a bloodstream deficit of the blood vessels that reach the hair follicles providing them with oxygen and everything necessary for their metabolism and for hair growth.

The vessels are composed of a layer of endothelial cells that separate the tissues from the bloodstream. Endothelial cells are affected by many stimuli and some stimuli reduce bloodstream and stop their reproduction, thus reducing microcirculation.

Of course stimuli can be very different in the different types of alopecia but they all affect the microcirculation that supplies hair follicles.

Here is the capillary scheme:

The cell you observe in the foreground is called pericyte and it is responsible for regulating the bloodstream in the vessels. Minoxidil has an effect on it, by improving the blood stream in the vessel, but it doesn’t affect endothelial cells that on the other hand are affected by many simuli, such as infective stimuli, hormonal pathologies, etc.

Prostaglandin E1 (PGE1) affects both pericytes and endothelial cells fostering a vasodilation and their reproduction.

About 6 years ago we observed that some cationic liposomes that transported PGE1 were able to reduce androgenetic alopecia effects (due to unknown reasons no further research was carried out).

About 4 years ago we developed a lotion containing cationic liposomes that transported PGE1, S-equol and carnitine and we started testing it on people with androgenetic alopecia and on a later stage on a girl with alopecia areata. The results were great and unexpected.

PGE1 improved microcirculation, s-equol stopped 5-α-reductase thus preventing testosterone to turn into dihydrotestosterone and carnitine entered the beta oxidation of lipid chains improving their metabolism.

You can observe that each hair follicle has a blood vessel reaching it.

Since PGE1 is considered a drug we tried to substitute it with its biochemical precursor, that is dihomo-gamma-linolenic acid (DGLA). The results were the same and even better than the ones obtained with the lotions containing PGE1. There are several scientific publications stating that in cellular cultures DGLA stimulates the production of keratin. As a consequence, taking these observations into consideration, we started experimenting with a lotion containing DGLA instead of PGE1 on female individuals with androgenetic alopecia. The results were published in “Il Dermatologo” Year XXXVII ‘ N’ 1/2015 ‘ March, page 26.

Nowadays a trial is being carried out involving 60 people suffering from androgenetic alopecia and I am carrying out a trial on 18 people with alopecia totalis or areata.

I am now going to answer Your questions:

Questions 1, 2 and 3. The lotion is very effective in the initial stages of alopecia, for people who are younger than 30 years old. The results are great and hair loss is completely stopped. Hair growth is witnessed and also miniaturized hair or even vellus gain their normal appearance again.

Of course the treatment gives clear results after circa 30 days and it has to be carried out for many months.

Question 4. According to our experience, once the patient obtains positive results, I advice they repeat the treatment at least three times a year, or they follow a maintenance therapy twice a week.

Question 5. The patients who responded better are the youngest ones and the ones in which androgenetic alopecia was in the initial stage (less than two years).

There was no difference between men and women.

Question 6. The individuals who are younger than 15 responded better, but also individuals who are up to 25 years old responded in a very good way. It was less effective on patients who are older than 40. Among young patients there was no difference between men and women.

Question 7. I have no information regarding this and therefore I can’t answer this question.

Question 8. At first photographic documentation was done randomly and we didn’t ask everybody to give us permission to show their photos. The only available photos are the ones displayed in the periodical “Il Dermatologo”. I then started focusing on alopecia areata and stopped dealing with androgenetic alopecia. Others stood in for this. The only people I treat now are friends of mine and I should ask them for permission to publish their photos.

Question 9 and 10. Above I explained how this lotion works. The small cationic liposomes firmly adhere to the scalp. The DLGA affects the endothelial cells making them more elastic and stimulating their reproduction improving their functionality. Moreover it stimulates the production of keratin. Equol prevents testosterone from turning to dihydrotestosterone by reducing its biochemical action. Carnitine improves the metabolism of the lipid chain easing their beta oxidation and fostering the tissue metabolism. As a consequence the adherence of cationic liposomes, the actions of DGLA on the endothelial cells and the stimulation in the production of keratin, the action of equol on testosterone and the action of carnitine on metabolism stimulate the existing hair follicles thus improving their functionality.

Question 11. The product proved its effectiveness also without equol, but by adding it you improve the effectiveness by 80%.

Question 12. Alopecia areata is caused by several stimuli that affect microcirculation but it often arises during puberty due to the hormonal changes that take place during that age, especially among women. PGE1 and its precursor DLGA are effective but equol boosts their action. PGE1 and DGLA are effective also by themselves in case of androgenetic alopecia but if they are associated with equol they are more effective.

Question 13. There are no substantial differences between PGE1 and DGLA.

Question 14. There were no side effects.

Question 15. The product is expected to be put on the market at the end of the trials.

Question 16. As far as I am concerned, there are no reasons that could prevent the commercialization of the product.

Question 17. To date we don’t think there could be any improvement, however everything changes.

Question 18 and 19. Considering our experiences, we don’t believe that we need to produce different products for patients with AGA and with AA.

Equol, as I said when I answered question 10, is useful also in case of AA because this condition often arises during period of hormonal changes.

Question 20. When we gave the lotion to a patient who had underwent a hair transplant, we noticed an increase both in the amount of hair and in the speed of growth. However it will be possible to carry out trials to prove this. Right now I don’t have enough information to give you an answer.

I would like to add something.

I gave a brief answer to all of Your questions but in order to provide you with all scientific data about the causes of Alopecia and the importance of a therapy I should write a whole university textbook chapter, indicating all the data and the bibliography of the various topics. However, since I am a retired university teacher specialized in vascular surgery I am not planning on writing any chapter about trichology.