Human growth hormone as Topical anti-aging/wound healing

[MAYIL]

Dear Dr,.Yechiel,

I am proud to be a member of your Forum and my wishes to you.

I need to know from your expertise that, Topical application of hGH is really a meaningful product to serve the purpose of healing the wound as well as a anti-wrinkling agent for human use?
HGH role in wound healing lacks substantial literature support as they were used in the very basic research level-mostly by systemic administration, without any significant clinical outcome and sometimes with deteriorating the conditions of existing wounds.
More over the topically used ones are at a very high concentration, which is not economically convincing at the large scale production level. No studies on HGH as topical conducted any stability studies, which is again a sensitive issue to address
With limited or no support on the use of Recombinant HGH for anti-wrinkling effect  as such, as a topical  agent, I come across  from few published patents  and a  company is  making and commercializing hGH  based formulations  for cosmetic use.

More over the hGH was encapsulated in the liposomes for their skin permeation. So far all the methods involving encapsulations were more suitable for chemically stable agents NEVER FOR A FRAGILE, SHEAR SENSITIVE PROTEINS.
As per the patent I read, the growth hormone was subjected into a very high pressure Homogenization cycles of 20-35 times at 1200 bar ( at upto 300 bars itself all the proteins will denatured) without any loss of its functional activity. Based on this they are making the product and selling it for consumer use?
Do you think this patent has any scientific sense and social scientific responsibility?
I need your valuable and genuine answer from your expertise ..Thanking you sir.

[DrYechiel]

Hello, MAYIL,

I am finally catching up with many writing projects and I hope that my response to your questions regarding growth hormones in topical use will prove worthy of the long wait.

I will start with the patent aspect that you mentioned. Indeed, patents are legal rather than scientific documents and their primary purpose is to turn an idea into property and. if possible, into profit. Some patents are based on well-established ground but many are based on partial or incomplete work and also tend to take a leap of faith in describing questionable or doubtful technologies which may not have been thoroughly researched or even proven to work. Many claims are stretched and exaggerated because the width of the claims and the length of the number of claims enlarges the perimeter of this property (no matter if sometime you find that you bought a large property in the middle of the waters of the Atlantic ocean, and it was not an island, either). Even minor patents are valuable in showing to investors that a company is innovative and active. It takes a special skill to read a patent and many people who believe they can really understand or evaluate patents are very wrong.

Growth hormones that were applied to wounds did not necessarily cause worsening of the wound. You have to remember that when you say “hormones were applied to a wound,” a chunk of cream containing less than 0.0001% of the hormones were actually applied. Creams are not made equally (some people already know that); when applying hormones, the cream has to be absolutely marvelous and superior and supportive of the hormones. Unlike steroid hormones, protein-based hormones are some of the most sensitive active proteins in nature and require far more than just special care: they require an environment that will not be destructive to them, which means that most emulsifiers and detergents are out of the question. They also require support that will not mask their activity. Many liposomes will not release large molecules such as active proteins from their boundaries. This said, there is great doubt that the growth hormones you described were actually enclosed within liposomes. Just because hormones and lipids are passed through a narrow aperture with high pressure does not mean that anything was encapsulated. On the contrary, when protein-based hormones are involved, there will be few that will be accidentally entrapped in the liposomes. Most will just remain free and probably have diminished activity due to the high pressure passage which is notorious for denaturalization of proteins. When we regard denaturalization of large and multi-unit proteins as growth hormones, the damage will be vast and mostly irreversible.

You have to consider some practical aspects regarding this subject. All you have to do is ask for some evidence on claims by that company. There is no point in asking them about features they don’t claim, but as you stated, they are saying:

1.   “The growth hormones are encapsulated in liposomes”. Ask what methods they used to support that statement.

2.   “The hormone activity is not reduced by the liposome encapsulation process”. Ask (A) How do they measure hormone activity (or what test do they conduct that is indicative of such hormone activity, because measuring the amount of hormone protein cannot differentiate between active or denatured protein) and (B) How do they measure hormone activity in a test tube if the hormone is still encapsulated in liposomes? (there should be no activity unless released undamaged from the liposomes).

3.   Ask how they make sure that the hormone penetrated the skin? Did they measure hormone activity in the skin? If so, how?

Extraordinary claims require extra ordinary proof (Carl Sagan famously said this). When dealing with products for skin, it’s unlikely that a manufacturer can verify so many large claims because it is enormously expensive and can take more than 5 years to perform. To use growth hormones as skincare ingredients requires at least ten-fold more hormone than usual, a custom-designed cream base, and formulation methods that ensure a reasonable level of protection and mobilization of hormone instead of trying to seal the hormones into liposomes and not knowing whether that attempt has succeeded.

For extremely sensitive proteins, we use a method that we developed and named “Turtle Head Encapsulation” This method gives high protection and mobilization to the proteins, but they are not sealed and the hormones (or enzymes) can act even under encapsulation. In fact, “Turtle Head Encapsulation” is a hybrid between encapsulation and complexing of specially modified Nanosomes™ (asymmetric Nanosomes™) and proteins. Such encapsulation is made with non-continuous barriers and so far is the most successful method for active protein utilization in topical formulations. If you are interested, I can further discuss some aspects of this but as you can probably tell, most of the technical aspects are proprietary.

Thank you for bringing up this area of discussion, and for your patience in waiting for a response. Growth factors are an interesting and important area of study and they are attracting some interest lately as skincare ingredients; I hope other forum members will contribute their own questions and ideas on this subject.