Exercise and Hair
Exercise and eating the right foods are the keys to a healthy lifestyle. We all know that. But how does exercise affect your hair health, hair loss, or hair regrowth? The answer might surprise you.
In general, exercise can help you maintain a healthy head of hair, and even help your body regrow hair. Regular exercise increases general health and circulation in your body. Increased circulation can stimulate growth in hair follicles. Also, exercise helps reduce stress in your life, and reduced stress helps with overall scalp health, according to Livestrong.com. So, if you exercise regularly, you are doing yourself—and your hair—a favor, right?
The answer might not be so simple.
Too much exercise, or overexertion, is actually bad for your hair. Excessive exercise causes a state of chronic stress in your body, according to author and nutritionist Ann Louise Gittleman. Chronic stress is a leading cause of telogen effluvium (TE), a condition that causes premature resting and shedding in hair follicles, according to the American Hair Loss Association. In addition, eHow.com explains that extreme bodybuilding and other extreme exercise activities can produce more dihydrotestosterone (DHT), which causes baldness in men. Conversely, mild exercise, like regular jogging or cardio, can help reduce DHT.
However, there is one form of mild exercise or cardio to think twice about if you are conscious about your hair health: swimming in pools. Most pools contain chlorine. The chlorine is there to keep the pools clean, but it can cause your hair to become dry and eventually break or shed. If swimming is your favorite form of exercise, you can avoid chlorine damage by wetting your hair with non-chlorinated water before getting in the pool (i.e., a locker room shower), so your hair absorbs the normal water, rather than the chlorinated water. Also, get out every 30 minutes or so and rinse the chlorinated water out of your hair. Wear a swim cap, and wash your hair after swimming with proper hair care products.
Another thing to keep in mind about exercise is that it causes you to sweat. Salty, heavy sweat build up on your head can cause faster shedding or other damage to your hair. The Harvard School of Public Health advises that you can combat this damage by using mild, pH-balanced shampoo and moisturizing protein conditioner at least once a week. Avacor offers both Thickening Shampoo and Volumizing Conditioner to help combat hair loss and stimulate hair regrowth. Avoid using hot hair tools as well, such as blow driers and curling irons.
The bottom line: exercise regularly, but avoid over-exercising or extreme exercise activities, and take good care of your hair with the proper hair care products. If you are eating healthy and exercising regularly, but still experiencing hair loss, consider using Avacor Physician's Formulation, an FDA-Approved hair re-growth product clinically proven to revitalize hair follicles and help you grow back hair.
Photo courtesy of Menscosmo.com
Babies and Baldness
Have you ever wondered why some babies might experience hair loss or thinning hair at such a young age? Some babies are born with little or no hair, while others are born with a thick head of hair. Many babies born with hair lose it within the months following birth, so the baby might have less hair at 6 or 12 months than they did when they were born. Other babies born with little or no hair might have thicker hair when they reach the 6 or 12 month mark, and some babies may appear bald throughout infancy and into early childhood.
The first thing to remember is that your baby's thinning hair (or lack of hair) is rarely a cause for concern, unless the baby's scalp or hair shafts look abnormal. Talk to your pediatrician and ask questions to give you peace of mind, but remember: it is completely normal for babies to lose their hair soon after birth, or to be born bald.
Next, it is important to understand that all human hair naturally goes through a growth cycle, including baby hair. At the end of this growth cycle, old hair sheds to make room for new hair. Sometimes, the shedding occurs before new hair begins to show, while in other cases, the new hair pushes the hair out of the follicle as it grows.
This growth cycle is the primary reason why some babies are born with hair and lose it, as well as why some babies are born with no hair. Simply put, the hair on a newborn's head starts going through the growth cycle before the baby is born. Babies born with a full head of hair have hair that is farther along in the growth cycle. Most of those babies begin to lose that hair soon after birth because the hair sheds to make room for new hair. The new hair may take several months to grow back, which can cause some parents to be concerned over why their new baby, who was born with a lot of hair, is now suddenly bald. Again, this is a common situation, but consult your pediatrician if you are concerned.
Babies born bald might have hair follicles that have not yet entered the phase of the hair growth cycle when hair appears on top of the head. Or, they might have already shed some hair while still in the womb.
Pediatrician Dr. Alan Greene indicates that most babies go through two hair cycles during the first year. For some babies, the old hair sheds at the same time the new hair begins to grow, so it appears as though they never lose any hair. When the cycles are spread out longer over time, the baby appears bald in between the two cycles. However, some baby hair takes longer to enter the second cycle—sometimes as long as 18 months—meaning the baby might not grow visible hair until he or she is a toddler.
Genetics and ethnicity also play a role in a baby's head of hair. They affect the amount of hair a baby has when born and during infancy, the timing of the hair growth cycles, and the texture of the baby's hair. The bottom line is, hair cycles in babies vary significantly, and periodic baldness throughout the first few years of life are rarely a cause for concern.
Photo Courtesy of Infantcrisis.org
The Importance of FDA-Approved Hair Products
We've all seen the term "FDA-Approved." But, do you know what it means? The United States Food and Drug Administration (FDA) is a federal government agency in charge of keeping the American public safe by regulating food, drugs, and medical devices. When a product or item is FDA-Approved, it has been rigorously tested and thoroughly inspected, and found to be both effective and completely safe for people to use or consume.
So, how does this relate to your hair?
Well, if you are experiencing hair loss, interested in hair restoration, or just curious about the process, you will undoubtedly encounter a wide variety of products to help stimulate hair growth. Many of these products are not FDA-Approved, which should be an automatic red flag. In other words, if a product is advertised to treat a medical condition, such as hair loss, but it does not indicate anywhere that it is FDA-Approved, then you should avoid using that product. You may be taking a major health risk using a product that is not FDA-Approved to treat any medical condition.
Avacor Physician's Formulation® is an FDA-Approved hair restoration product clinically proven to revitalize hair follicles and help you grow back your very own hair. The FDA has carefully tested and inspected how the product is manufactured, what ingredients are used, how much of each ingredient is used, how the product is stored and packaged, and how the product is administered. In other words, all aspects of Avacor Physician's Formulation production, including each ingredient, the bottling process, and the recommended dosage, have been deemed completely safe and effective for consumers to use for the treatment of hair loss, according to the FDA.
Unfortunately, some consumers continue to be tricked into buying "snake oil" products, or hair loss treatments not approved by the FDA. These products can cause unhealthy and unwanted side effects, such as acne, scalp hair loss, menstrual irregularities in women, irritability, and aggression, according to Dr. Ray Sahelian. The FDA also indicates other side effects of hair growth products that are not FDA-Approved include low blood pressure, heart palpitations and other cardiac symptoms, hair discoloration, sensitivity to sunburn, itching, rash, irritation, or stinging skin. "Snake oil" products are a waste of time and money. They also taint consumer's opinions of the entire industry, making consumers skeptical of all hair loss products, including the legitimate ones. Additionally, they can add more emotional stress in your life when you buy the product and it doesn’t work, and/or causes health problems.
The good news is that the FDA is starting to crack down more on snake oil salesmen and punishing people with fines and/or jail time for trying to sell hair regrowth products to consumers that are not FDA-Approved. However, consumers still need to be aware of the product they are buying.
The active ingredient found in Avacor Physician's Formulation is Minoxidil. Currently, the FDA has approved Minoxidil in two different strengths: 5% for men and 2% for women. The Avacor product has Minoxidil levels that adhere to these requirements. If the levels were anything different than the 2% and 5% required by the FDA, the product could not be advertised as FDA-Approved, and could be recalled by the FDA at anytime.
In January of 2012, the FDA issued a press release announcing the recall of some hair regrowth products because they were unapproved new drugs, and had high levels of Minoxidil that could cause health hazards to consumers. These products had Minoxidil levels between 10 and 15%. If you are currently using a hair regrowth product, be sure to check the Minoxidil level, and consider switching to Avacor's FDA-Approved Physician's Formulation, as well as other hair care products: the Avacor® All Natural Nutricap containing the active ingredient Saw Palmetto, which is widely thought to be a DHT inhibitor; Boost! by Avacor®, which is specially formulated to thicken hair from the very first application; and our Scalp Detoxifying Shampoo, which removes dirt and oil from the scalp, ensuring effective delivery of the Minoxidil to the scalp when applied after using the shampoo. Rest assured that all our products are manufactured in facilities that meet the highest safety and quality standards today. Furthermore, all our products are safe to use, and have been formulated to either help you grow a natural, full, healthy head of hair, or to maintain healthy, clean, and stylish hair.
Shedding Hair
Shedding is a natural process for all living things. People and animals physically shed hair and skin. People trying (successfully) to lose weight shed pounds. Those hoping to make life changes shed unwanted aspects of their lives, such as unnecessary personal belongings, bad influences, or relationships with other people. Shedding, whether physical, emotional, or otherwise, is essentially a process in which you get rid of something that has served its purpose and is no longer useful to you.
When it comes to your hair, shedding naturally occurs at the end of the hair follicle growth cycle. Hairs on your head go through this cycle and naturally fall out, or shed, to make room for new hair. All people shed their hair, even those who are not experiencing male pattern baldness or female pattern baldness. However, shedding can still be alarming or frustrating, especially if the hair you shed does not grow back.
Baldness is caused by hair follicles that do not produce new hair after old hair is shed. However, according to MedicinePlus, the hair follicle remains alive, even when it stops producing hair. In other words, it is possible for an inactive hair follicle to produce hair again, even after baldness.
Enter FDA-approved hair regrowth treatment Avacor Physician's Formulation®, which is clinically proven to revitalize hair follicles in as little as two months. Once a hair follicle is revitalized, it can begin naturally producing hair again.
However, you still might experience shedding when you begin using Avacor Physician's Formulation. Do not be alarmed, as shedding is quite common, especially at the beginning of treatment. In fact, shedding after you start to use the product is a positive sign that the product is beginning to work.
The reason? At the beginning of the hair follicle growth cycle, new hairs need room to grow, so they push dead hairs out of the way as they sprout upwards. However, older hairs can still remain on your head if new ones do not begin to grow. The older hair might not naturally shed, and is not pushed out by new hair, because the hair growth cycle is essentially paused. When you revitalize the hair follicle using Avacor Physician's Formulation, the growth cycle resumes, shedding all dead hairs that have not yet fallen off on their own. If you notice shedding at the beginning of your treatment, just continue to use the product as directed.
You might also notice occasional shedding throughout your treatment. This is because shedding happens naturally, to everyone. Shedding is, in fact, a sign that hair follicles are actively eliminating old hairs as they produce new ones. Do not be concerned with the shedding; instead, pay attention to whether your hair follicles are producing new hairs to replace the ones that have been shed.
Lastly, it is important to be patient, especially at the beginning of treatment. Avacor Physician's Formulation is clinically proven to revitalize hair growth, but growing a full head of hair takes time. You will not wake up the next morning with a full head of hair, but if you stay the course and use the product as directed, you will be rewarded with rejuvenated hair follicles, and natural, new hair on your head.
The Hair Follicle Growth Cycle
All living things go through various stages or cycles of life. While the details differ from one thing to the next, all cycles include some form of birth or creation, development or maturation, and ultimately, some sort of expiration or death. Your hair is no different. Hair loss, hair restoration, and re-growth are all impacted by the hair follicle growth cycle, so let's take a closer look at that cycle to help better understand why you lose hair, and why hair restoration products, like FDA-approved Avacor Physician's Formulation®, really do work.
The hair follicle growth cycle is broken up into three phases:
- The Anagen phase is the hair growth phase
- The Catagen phase is a transitional phase
- The Telogen phase is the resting phase.
The Anagen phase lasts anywhere from two to six years. This is the stage when hair follicles produce and grow individual hairs. Hairs grow about six inches a year on average, meaning that a few months into this phase, you can have hair that is a few inches long. The Anagen phase is further broken up into six stages; basic information about each stage is below.
- Stage 1: Cell division begins; hair growth at the microscopic level
- Stage 2: Follicle grows downward, and surrounds cells, which continue to grow
- Stage 3: Hair begins to take shape and melanin production begins
- Stage 4: Cells begin pigmentation (hair color)
- Stage 5: Hair shaft begins to sprout
- Stage 6: Follicle is completely developed
Another interesting fact about the Anagen phase is that at any given time, about 85% of the active hair follicles on your head are in this phase. As people get older, the Anagen phase might become shorter, resulting in smaller, finer hair. This is why adults sometimes experience thinning hair, and eventually, baldness.
The Catagen phase lasts one to two weeks in most cases. During this phase, the follicle base and hair shaft continue to move upward, thought the follicle shrinks to about 16% of the normal size.
The Telogen phase lasts between one and two months. During this phase, the hair does not grow, but it remains attached to the follicle. It is sometimes referred to as the "resting phase" because the hair basically just rests, without growing or falling out (shedding). Roughly 10 to 15% of all hair is in the Telogen phase at any given time.
At the end of the Telogen phase, the follicle starts the cycle over again. The old hair from the previous cycle either falls out on its own, or is pushed out when the new hair begins to grow in the Anagen phase.
Each hair follicle is on its own unique schedule of this growth cycle. If they were all in sync, you would lose all your hair at the same time, and regrow it at the same time. Because of the varying schedules, your hair is constantly growing, shedding, and growing again, simultaneously.
When you begin treatment to regrow or rejuvenate hair growth using Avacor Physician's Formulation, it is important to be patient. Your hair will not grow back overnight. Avacor Physician's Formulation has been clinically proven to revitalize hair follicles in as little as two months. However, when hair follicles are revitalized, they must still go through the hair follicle growth cycle to begin growing new strands of hair. Specifically, once revitalization occurs, the follicles must go through at least a few months of the Anagen phase to generate new hair that is a few inches long.
Stay tuned for the next post, which will discuss shedding in more detail.
The History of Hair Loss – Part 1: Hair Loss and Remedies Over Time
If you are experiencing premature hair loss, or thinning hair, you are not alone. In fact, premature hair loss has been an issue for people throughout history. Thousands of years ago, ancient Egyptians shaved their heads and wore wigs or elaborate head pieces to combat hair loss and display royalty and wealth. They also created a variety of potions, ointments, and other methods to treat hair loss. Some ointments included boiled porcupine hair or hippopotamus fat, according to the 1550 B.C. medical text, The Ebers Papyrus. Clearly, these options would not be FDA-approved today.
The Bible also mentions hair loss a few times. In 2 Kings 2:23-24, Elisha was mocked by a number of youths, shouting "bald head" and "baldy" at him as he walked into the town of Bethel. Angered and embarrassed, he cursed them and took his revenge by summoning two bears from the woods. It didn't cure his baldness, but it also didn't end well for the youths.
Julius Caesar wore the original Caesar hair style, but he was also bothered by his hair loss. According to Suetonius, Caesar combed his "scanty locks" forward to hide his thinning head of hair. Some also speculate that he wore the traditional laurel wreath to cover up his baldness. Oddly enough, the Latin word "caesaries" translates to "long/flowing/luxuriant hair."
In the Middle Ages, King Louis XIII of France began the big wig era by wearing a long, curly wig after losing his hair prematurely. This fashion trend spread throughout Europe and across the pond to the American colonies. Many European and American politicians and scholars—men and women alike—wore large wigs, not only to be fashionable, but to hide their thinning hair or bald heads. Even after the American and French Revolutions, when the big wig was seen as a symbol of the old regime, people wore white, powdered wigs.
Cowboys in 19th century America attempted to stop thinning hair with various snake oil products and messy grease rubbed into the scalp. Also, let's not forget the infamous cowboy hats, which offered protection from the sun, and conveniently hid bald heads underneath.
In the modern era, hair loss continues to be an issue. For some people, losing hair is an emotional and stressful time, while it is a health issue for others. Hair loss can lead to lower self-esteem, high anxiety, depression, and issues with sexual attractiveness and social acceptance. It can also trigger fears about getting older, and even dying. Avacor Physician's Formulation ® is an FDA-approved hair restoration and re-growth product that has been clinically proven to revitalize hair follicles in as little as two months. Thankfully, we live in a time when we do not need to rely on snake oils, obnoxiously large wigs, animal fats, or vicious bears.
Stay tuned for Part 2 of The History of Hair Loss, which will discuss the importance and symbolism of hair throughout history.
The Future of Hair Regrowth: Part 4 – Stem Cells
Some of the most anxiously awaited treatments on the hair growth horizon are those that seek to harness the power of stem cells to regrow hair. This post will give you a brief introduction to stem cells and describe some of the research and development programs focused on developing treatments for hair loss.
Stem Cells 101
Each tissue and organ in the body is made up of cells with specialized structures and unique functions. These specialized cells are generated by a process called “differentiation”, in which immature, undifferentiated cells give rise to mature, differentiated cells that are equipped to carry out specific roles.
The most versatile type of stem cells, called embryonic stem cells (ESCs), arise in the earliest stages of development and give rise to every cell type in the body. The use of human ESCs has been a source of controversy because their isolation usually requires the destruction of an embryo.
Adult stem cells (ASCs), present in low numbers in the body throughout our lives, are capable of producing multiple cell types but are already committed to a particular developmental pathway. Examples of ASCs include hair follicle stem cells, which are responsible for the growth and maintenance of hair follicles, and hematopoietic stem cells, which give rise to the various red and white blood cells that carry oxygen throughout our bodies and protect us from infections.
Promising Research into Stem Cell-Based Treatments for Alopecia
Earlier this year, the research group of Dr. Roland Lauster at Berlin Technical University published an exciting report1 in the Journal of Biotechnology detailing a method that could lead to a stem cell-based treatment for hair loss.
Dr. Lauster's group isolated dermal papilla cells from human scalp hair follicles and cultured them using the same methods as have been used for culturing embryonic stem cells and mesenchymal stem cells. The cells first formed small clusters and approximately 13.5% of these “microfollicles” eventually began to grow hair-like fibers, as shown by light microscopy and electron microscopy in this figure from the paper.
The authors suggest that their “robust, reproducible method” is a “good jumping-off point for further work” on treating male pattern baldness or chemotherapy-induced alopecia. While the hairs produced in the study were similar to vellus (fine, peach fuzz) hairs, they suggest that “with further experimentation, it may be possible to cultivate hair of different thickness, color or texture.”
Eventually these microfollicles might be produced in large quantities from a patient's own cells and injected back into the scalp, where they could form new hair follicles and grow new hairs.
Histogen and Follica: Company Profiles
Two of the most notable commercial efforts in stem cell-directed therapies for alopecia are being spearheaded by the companies Histogen and Follica. Rather than implanting stem cells into the scalp to create new hair follicles, these companies are developing methods and formulations that would stimulate the development or activity of cells already present in the scalp.
Histogen, Inc.
Location: San Diego, CA
Background: Founded by Dr. Gail Naughton, former co-founder, President and Vice Chairman of the now liquidated human tissue engineering company Advanced Tissue Sciences, Inc.
(click here to listen to an interview with Dr. Naughton on TheBaldTruth.com)
Technology: Histogen's Hair Stimulating Complex (HSC) is a mixture of soluble protein factors such as Wnt7a, VEGF, KGF, and follistatin. These proteins are secreted by cells, called embryonic fibroblasts, which are grown in a controlled laboratory environment.
Development status: Histogen has completed a double-blind, placebo-controlled Phase 1/2 clinical trial of HSC to evaluate its safety and efficacy as an injectable for hair growth. According to the Histogen website, no adverse events were observed and HSC was found to increase hair count, hair thickness, and hair density at the 12 week endpoint with continued growth observed 12 months later.2 No Phase 3 details have been released yet.
Follica, Inc.
Location: Philadelphia, PA
Background: Founded around the pioneering research of Dr. George Cotsarelis, a professor at the University of Pennsylvania, who has been studying hair follicle stem cells for over 20 years and published an early pioneering article in the journal Cell in 1990.3
Technology: Cells in the scalp are coaxed into generating hair follicles by first wounding the target area and exposing the healing tissue to stem cell modulating factors such as Wnt pathway activators.4 The company is developing a device that would perform the wounding in a controlled fashion.
Development status: Follica's development program is still in its early stages. A recent article by Dr. Cotsarelis showed that stem cells are still present in normal numbers in the scalp of men affected by androgenic alopecia,5 suggesting that their focus may shift toward increasing the production of progenitor cells, the next cell type in the differentiation cascade. An article on Xconomy.com this year quoted the CEO as saying that clinical trials are underway outside of the U.S.
Conclusion
While stem cell therapies are exciting and may hold great potential for treating diseases and regrowing damaged tissues, they have proven difficult to commercialize: after 20 years, Geron, one of the leading developers of embryonic stem cell-based therapies for neurological diseases, has given up and shifted towards developing drugs for cancer.
Still, thousands of people who suffer from alopecia hope this promising field of research and development will eventually lead to a solution for hair loss.
Check back soon for the final installment of the Avacor® Hair Regrowth Blog’s series on The Future of Hair Regrowth to learn about some of the many novel, early-stage research programs that may lead to new treatments for hair loss in the future!
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1. Lindner G, Horland R, Wagner I, Ataç B, Lauster R. De novo formation and ultra-structural characterization of a fiber-producing human hair follicle equivalent in vitro. J Biotechnol. 2011 Mar 20;152(3):108-12. Link to PubMed
2. Histogen website. (accessed 11/16/2011) http://histogen.com/applications/hsc.htm.
3. Cotsarelis G, Sun TT, Lavker RM. Label-retaining cells reside in the bulge area of pilosebaceous unit: implications for follicular stem cells, hair cycle, and skin carcinogenesis. Cell. 1990 Jun 29;61(7):1329-37. Link to PubMed
4. Ito M, Yang Z, Andl T, Cui C, Kim N, Millar SE, Cotsarelis G. Wnt-dependent de novo hair follicle regeneration in adult mouse skin after wounding. Nature. 2007 May 17;447(7142):316-20. Link to PubMed
5. Garza LA, Yang CC, Zhao T, Blatt HB, Lee M, He H, Stanton DC, Carrasco L, Spiegel JH, Tobias JW, Cotsarelis G. Bald scalp in men with androgenetic alopecia retains hair follicle stem cells but lacks CD200-rich and CD34-positive hair follicle progenitor cells. J Clin Invest. 2011 Feb 1;121(2):613-22. Link to PubMed
The Future of Hair Regrowth: Part 3 – RNA Interference
Another possible strategy for combating androgenetic alopecia in the future could involve harnessing a molecular phenomenon known as RNA interference (RNAi) to block the expression of the genes that cause hair loss in the first place.
Molecular Biology 101: What is RNA?
Ribonucleic acid (RNA) is a biological polymer that is essential for all known forms of life. One type of RNA, known as messenger RNA (mRNA), carries genetic information derived from DNA (the master genetic "blueprint") out of the cell nucleus to the cytoplasm where it is translated into proteins (e.g., receptors or enzymes).
(For more details on RNA check out the entry on Wikipedia.)
The Science Behind RNAi
Years of research on gene expression in plants, worms, and eventually mammals, have led to the understanding that small fragments of nucleic acids like RNA can specifically block the production of any given protein in a cell.1
Small interfering RNAs (siRNAs) are short fragments of RNA, approximately 19-23 nucleotides in length, which recognize and bind to specific sequences in a target mRNA and recruit RNAi machinery (including an enzyme called "Dicer") that chop up the target mRNA. Once the mRNA is cleaved, it can no longer be translated into the corresponding protein it encodes. With the sequencing of the human genome completed, siRNA sequences can be designed to specifically target almost any gene.
RNAi technology could be utilized in the context of treating androgenetic alopecia to inhibit the production of proteins that are involved in hair loss or that slow the growth of hair.
Given the widely recognized role of dihydrotestosterone in hair follicle miniaturization and pattern hair loss, two particularly attractive targets for RNAi therapy are the androgen receptor (AR) and the 5-alpha reductase enzymes.
(For background information on DHT, AR, and 5-alpha reductases in hair loss, see our previous posts on anti-androgens here and here.)
This strategy is supported by several scientific papers, including one published in 2009 that focuses on blocking expression of AR:2
“Antiandrogen therapeutic oligonucleotides targeting the downregulation of the AR expression is advantageous because both will be possible to eliminate the only way for androgens to act and simultaneously this strategy allows the medication to be topically administrated. In fact, this could be very useful in a long-term treatment of, for instance, androgenetic alopecia...”
A Possible Manufacturer?
A company called Sirna Therapeutics described just such an approach in a patent application, published in 2005 as US 2005159376 A1. In the application, Sirna suggested using siRNA targeting either AR or 5-alpha reductase to treat alopecia:
“Specifically, the invention relates to small nucleic acid molecules [...] capable of mediating RNA interference (RNAi) against 5-alpha reductase and/or androgen receptor. Such small nucleic acid molecules are useful, for example, in providing compositions for treatment of traits, diseases and conditions that can respond to modulation of 5-alpha reductase and/or androgen receptor expression in a subject, such as alopecia, acne, polycystic ovary disease, prostitic hypertrophy, and prostate cancer.”
Since RNA does not cross the cell membrane or the skin barrier efficiently, one approach for delivering siRNA molecules is to encapsulate them in a sphere of "phospholipids" similar to those that make up the cell membrane. These spheres, known as liposomes, would cross through the skin and facilitate the entry of siRNA into the desired cells in the hair follicle.
“The siNA molecules of the invention are added directly, or can be complexed with cationic lipids, packaged within liposomes, or otherwise delivered to target cells or tissues. The nucleic acid or nucleic acid complexes can be locally administered to relevant tissues ex vivo, or in vivo through direct dermal application, transdermal application, or injection, with or without their incorporation in biopolymers.”
Here is an example of how such a treatment might be delivered:
Not Quite There Yet
While the approach outlined above will theoretically be effective as a treatment for androgenetic alopecia, some details still need to be worked out. Delivery with simple liposomes works very well in cell culture models, but may not be as effective in the more complex environment of the skin. According to a review article published this year:
“More efficient drug delivery vehicles are therefore being sought. Among the newly emerging concepts, drug delivery systems based on nano- and microparticles, which efficiently penetrate via the follicular route, are highly promising approaches.”3
“Nevertheless, this is still a very incipient area that promises to bring new and highly targeted strategies for skin and hair diseases.”
As with all the other treatments described in this series of posts, any therapeutic strategy would need to be tested in clinical trials to make sure it is safe and effective before approval by the FDA.
Thanks again for joining us this week as we look into The Future of Hair Regrowth. Don't forget to come back soon for the next installment in the series, which will cover what may be the most promising area in hair growth research today: stem cells.
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1. Zamore PD, Tuschl T, Sharp PA, Bartel DP. RNAi: double-stranded RNA directs the ATP-dependent cleavage of mRNA at 21 to 23 nucleotide intervals. Cell. 2000 Mar 31;101(1):25-33. Link to PubMed
2. Dugour A, Hagelin K, Smus C, Balañá ME, Kerner N. Silencing the androgen receptor: new skills for antiandrogen oligonucleotide skin and hair therapy. J Dermatol Sci. 2009 May;54(2):123-5. Link to PubMed
3. Araújo R, Fernandes M, Cavaco-Paulo A, Gomes A. Biology of human hair: know your hair to control it. Adv Biochem Eng Biotechnol. 2011;125:121-43. Link to PubMed
High Dose Minoxidil Products – Lack of Evidence for Safety and Efficacy?
Several online distributors now offer products that contain minoxidil in higher doses than have been approved by the U.S. Food and Drug Administration (FDA) or that contain minoxidil in combination with additional active pharmaceutical ingredients.
Although the FDA has only approved minoxidil at concentrations of two percent (2%) or five percent (5%) for the treatment of hair loss, some products available over the internet contain minoxidil at concentrations as high as 15%. Many are formulated with additional ingredients such as azelaic acid, retinoic acid, caffeine, and even finasteride (the active ingredient in Propecia®), in combinations that have not been reviewed by the FDA.
The FDA evaluates two major concerns when considering new drug applications – safety and efficacy. Until these products are tested in clinical trials, there is no way to ensure that they are safe or to know whether high doses of minoxidil even provide any benefit over products that have been approved by the FDA.
Misleading Marketing?
Some consumers may find the marketing of these products to be misleading because of references to the FDA or to claims based on FDA-approved products containing 2% or 5% minoxidil.
The website for MinoxidilMax claims to offer “effective hair regrowth products... for male pattern baldness (alopecia androgenetica)” with “unmatched effectiveness.” Their products are manufactured “by an FDA registered cGMP compliant facility,” contain “the only effective ingredient approved by FDA in topical hair regrowth solution,” and have “the maximum strength of FDA approved hair growth stimulator (15% minoxidil).”
Consumers who read further on the company's website may be surprised to find that their products are not FDA-approved and that “the statement on this website has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease.”
Another manufacturer, Perfect Image Solutions, offers high dose minoxidil products “specifically formulated to treat conditions associated with male pattern baldness (Androgenetic Aloepicia).”
The FAQ section of the website relies on the long history of FDA-approved minoxidil products like Rogaine® to imply that high dose minoxidil products must also be safe:
“How do I know using a high concentration of minoxidil isn’t an overdose?
Minoxidil has been on the market for over 20 years with an extremely low incidence of side effects, especially from topical application.”
Although claiming that the products are “clinically proven to yield unparalleled results in the field of hair loss,” manufactured in an “FDA registered cGMP compliant facility,” and that all ingredients, “including Minoxidil must meet all FDA guidelines,” the website does not provide any evidence of clinical trials demonstrating the safety or efficacy of its products.
FDA Takes Action
Earlier this year, Regrowth LLC, a well known distributor of high dose "specialty" minoxidil formulations (formerly sold under the name Xandrox), released the following statement on its website:
“We're very sorry to inform you that Regrowth LLC has to suspend all operations at this time. In an ongoing audit, the U.S. FDA has deemed our medications to be 'unapproved illegal drugs'.”
Regrowth LLC had been selling minoxidil formulations containing 15% minoxidil (three times the FDA-approved dose contained in products such as Rogaine® and Avacor Physicians Formulation®).
On May 25, 2011, the FDA initiated a recall of 57,999 bottles of Regrowth LLC's products, stating that “[t]hese products are unapproved drugs and may present potential health hazards.”1 Based on this recall, it would not be surprising if the FDA takes action to stop other distributors of high dose minoxidil formulations/combinations from selling unapproved drugs in the future.
Conclusions
At the time of posting this article, we are unaware of any clinical trials proving that products containing higher concentrations of minoxidil than 5% are safe or more effective than FDA-approved products containing 5% minoxidil.
In January, Dr. Glenn Charles, a member of the International Alliance of Hair Restoration Surgeons, commented:
“I have not seen any studies comparing 5% Minoxidil with higher % Minoxidil concentrations. I would imagine that the incidence of side effects might be higher with greater % of Minoxidil. However, many of the reported side effects might actually be caused by the other ingredients in these hair loss products containing Minoxidil.”
If you are still interested in experimenting with formulations containing high dose minoxidil or combinations with other active ingredients, it may be a good idea to consult with a physician before you begin using any such products.
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1. Enforcement Report for May 25, 2011: RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II. FDA.gov (accessed September 8, 2011).
http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm256794.htm
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