HAIR LOSS REMEDIES: LOTIONS AND POTIONS

Hair Transplant Forum International May/June 2003
Matt L. Leavitt, DO Heathrow, Florida

Introduction
Over the past two years, there has been a marked increase in the number of products being promoted as solutions to hair loss. These formulations and devices pander to the populations desire to find some way to halt this visible sign of aging.

The latest statistics report that an estimated 80 million men and women are affected by hair loss in the United States. Only 3% of this staggering number search out some sort of solution, whether it is medical, surgical, or non-medical.

There are only three medically proven methods of dealing with hair loss: hair transplantation, minoxidil, and finasteride. Surgical hair transplantation is the only one of these methods that provides a permanent solution. Both minoxidil and finasteride require continued use to become and remain efficacious; once discontinued, hair loss ensues.

Despite the availability of these proven methods, there is an enormous segment of the public suffering from hair loss who try unproven hair loss remedies. Numerous products claiming to be "natural," "safe," "drug free," and effective against hair loss are heavily marketed in the media. These "buzz words," coupled with the virtual anonymity of purchase, are attractive and are garnering huge attention.

Historically, there have been two dramatic influxes of these types of products. The first began in 1988 and was spurred by the 1988 FDA approval of minoxidil, marketed as Rogaine^®. Copycat products could not offer clinical statistics to substantiate their claims and, eventually, the Federal Trade Commission (FTC) stepped in to regulate these producers.

In 1996, the introduction of Rogaine 5% and Rogaine's new over-the-counter status raised further awareness in the public in addition to the 1997 introduction of Propecia^® (finasteride).

The expiration of the patent on Rogaine in December 2000 started the next big increase of hair loss products. Minoxidil (marketed as Rogaine), which had been sold over the counter since 1996, now was in the public domain and available to other manufacturers.

This generation of non-prescription products that proclaim to be natural, safe, and effective solutions for hair loss are usually not what they claim.

Products are often based on minoxidil in some form, saw palmetto (an unproven herbal remedy), and/or other products that claim to be DHT inhibitors. Propecia is the only DHT inhibitor the FDA has approved for hair loss.

Distribution of these potentially bogus products has never been easier, and consumers can purchase them anonymously from numerous Internet sites. The FTC has been slow to regulate efficacy of these unproven products.

What Works
Minoxidil is the first of the drugs approved for hair loss. Introduced in 1988 after the FDA gave its approval, Rogaine has been an effective medication for hair loss for both men and women. The topical formulation is now available in 2% and 5% strengths, and has been over-the-counter since 1996. The treatment is a hair growth stimulator and works by activating potassium channels in follicular cells. VEGF and prostaglandin synthase expression is indicated. Numerous clinical studies have been done and reported for both hair growth and hair maintenance end points.

Finasteride is the newest medication to be approved by the FDA for hair loss. Approved in 1997, it is a 5-alpha 2 reductase blocker and lowers DHT levels, which results in hair maintenance and may result in hair growth. Clinical studies show a remarkable 90% of the study either gained or maintained their hair over five years compared to placebo.

Hair Restoration is the only permanent solution for hair loss. A surgical treatment, the procedure transplants viable hair from the donor area to the recipient locations.

What Is Trendy?
Currently, the products generating the most interest are Avacor, nioxin,
dutasteride, and saw palmetto.

Avacor^®, from Global Vision 2001, is a heavily marketed product that is a three-fold system of a DHT blocker, topical solution, and scalp detoxifying shampoo. It claims to be an all-natural, herbal formulation that is effective immediately, with results shown in 4-6 months. It is a hair-growth stimulator based on a formulation of 2,4-di-amino-6d piperidino-pyrimidine 3 oxide, or, in other words, minoxidiI 2%.

It also contains sabal serulate, an androgen modulator, more commonly known as saw palmetto. While the company uses "clinical" data to support its claims, they are in actuality a "non-peer-reviewed, non-double-blind, seemingly scientific study subsidized by the makers of the product."¹ The average cost is $220 for a 3-month supply.

Nioxin^® is a cleanser scalp therapy and scalp serum. The product contains niocidin, which inhibits demodex produced lipase.² However, "there has
never been any study, that I am aware of that implicates demodex lipase in hair loss" or "that shows that hair will benefit from getting rid of mites or their lipase."³ Nioxin is based on bionutrient actives and protectives. Their primary methodology is to clean the scalp of DHT and to provide chemically enhanced hair with moisture/vitamin nourishment. Primarily available in salons, the product can now be found in other retail outlets.

Dutasteride, from Glaxo Smith Kline, is the most promising of the products or medications outside of the three therapies mentioned above. Approved by the FDA only for use with prostate therapy, it was not submitted for male pattern baldness. It is a DHT blocker that blocks both forms of 2-alpha reductase enzymes (type 1 and 2). Early studies show promising results, that is, slightly better than finasteride; however, the potential side effects require further trials and testing for overall efficacy and safety. Other early indications show that it has a longer half-life than finasteride and that the safety data is consistent with DHT reduction. It is still awaiting phase III trials. Dutasteride has been marketed with the brand name Avodart^®.

Saw palmetto is available from multiple sources. It is an over-the-counter herb that has been claimed as effective as a supplement for thinning hair. It has shown to be beneficial in men with benign prostatic hyperplasia, but does not affect testosterone, DHT, or PSA levels.⁴ It has exhibited alpha androgenetic receptor blocking activity in vitro.⁵ General usage recommends raking 400mg of standardized extract with 100mg of beta sirosterol daily. It is claimed that results will appear in five months.

There are numerous other products and devices available to the consumer A random sampling of the most prominent products is shown in the following text. The products have been categorized by the operative mechanism or by their key, active ingredients.

Lotions, Potions & Shampoos
Herbals, minoxidI1-based, oils, and vitamins Folliguard Extra, from Jungle MD, is very similar to Avacor both in terms of usage and formulation. Specifically, it uses a system of DHT blocker and scalp detoxifying shampoo. Its active ingredients are minoxidil 2% and saw palmetto. It costs approximately $200 for a 3-month supply.

Hair Advantage, from Daniel Rogers Laboratory, is extremely similar to both Avacor and Folliguard. It uses a DHT blocker, nutrient serum, and scalp detoxifying shampoo. Its ingredients are composed of Ioniten (better identified as minoxidil), saw palmetto, tarakaci, notoptcryl, maidenhair tree, vaccinium murtillus, and equisetum. The estimated cost is $180 for a 3-month supply.

Xandrox also claims to contain a DHT blocker as well as a topical solution. Its active ingredients are minoxidil (12.5% micronized), azeleic acid 5%, and betarnethasone valerate. The company reports that the 12.5% micronized minoxidil works on the temple and hairlines (non-responsive areas), while they say the azeleic acid can act as a DHT inhibitor.

Herbal Products
Hair Genesis^TM, from Dr. Geno Marcovici and Sunset Marketing, sells for $270 for a 3-month supply. It uses a system of a special shampoo, conditioner, supplements, and a serum. It also uses "botanicals" to inhibit type I and II 5-alpha reductase and decrease DHT. Results are claimed to appear in 6 months and it is described as being safe for both men and women.

Nu Hair^TM, from Biotech Corp, sells for $180 for a 3-month supply. It claims to be a "supplement" for thinning hair. Its active ingredients are he shou wou, saw palmetto, horsetail, henna, rosemary, progesterone, and
nettle.

Hair Prime^TM, from Universal Biologics, sells for $210 for a 3-month supply. It requires a regimen of shampoo, lotion, and primer to deliver "nutrients." It has two herbal and vitamin supplement tablets containing pantothenic acid, biotin, and zinc. It claims to be a natural herbal treatment and that 9 out of 10 people have healthier hair growth.

Biologic Products
Emu Oil, studied by Boston University Medical Center, is a topic product that sells for $9.50 an ounce. Its "credentials" cite a Dr. Michael Holick, who reported a clinical study showing that Emu Oil accelerated skin regeneration and stimulated hair growth. They claim that 80% of hair follicles began to grow hair in non-clinical studies,

Thymuskin, from Biotechne Complex Inc., sells for $210 for a 3-month supply. It is a topical solution that must be massaged directly into the scalp. It contains the extract of calf thymus glands and claims to boost immune function. The company admits it is not effective for male pattern baldness or
androgenetic alopecia, the most common types of hair loss.

FNS, or Follicle Nutrient Serum, from Osmotics, sells for $65 for a 4-ounce tube. It is a topical solution that claims to contain a unique delivery system of nutrients. It has a three-fold mechanism that includes a growth hormone potentiator, a cell culture medium, and a vehicle. It is marketed as a cosmetic product and will not be submitted for FDA approval. No trials have been performed to date.

Vitamin & Mineral Products
Hair -ZX^TM, from Vitafree, sells for $250 for a 3-month supply. It is a three-part system including a shampoo, a topical, and a DHT blocker. It is available through the Internet and direct sales. It claims to regrow lost hair as well as to produce larger, healthier follicles.

Folligen^TM is available in three formulations: a cream for hairlines, a lotion for denser areas of hair, and a solution therapy spray for misting over the hair. It is available through the Internet and direct sales. It is a copper peptide–based product. Its functionality is based on the theory of increasing blood supply to the scalp to combat hair loss.

Triaxon^TM is a topical treatment. It is available through the Internet and direct sales. It is comprised of a combination of vital nutrients and vitamins and reports it has a higher level of active ingredients designed to promote new growth. It claims to help reduce DHT levels by 90% and to give users immediate results.

EPM, from Sumitomo Electronics, is an over-the-counter topical treatment comprised of 10 amino acids. Its active ingredient is epimorphin. No clinical trial data is available and it is not available in the United States.

Miscellaneous Products
Kevis^®, by Farmaka, sells for $650-$975, depending on the package you choose. It is available through the Internet and direct sales. It includes a topical lotion, a shampoo, and a topical "accelerator" that must be applied with applicator and massaged. It claims to block DHT or the androgen receptor. The company indicates clinical testing done in Europe.

Procyanidin B-2 is a combination shampoo, lotion, and primer as a regimen to deliver nutrients. It is a polyphenol compound, found in apples, which is said to act on hair epithelial cells as a growth-promoting factor. Their own study indicated "an increase in the number of hairs and the diameter of hairs in the designated scalp area compared to placebo." No statistics or data were provided.

Revivogen^TM, from Advanced Skin and Hair, costs $99 for a 3-month supply. It is available over-the-counter and includes a scalp therapy formula and bio-cleansing shampoo. It says it is an anti-DHT product, and claims there are no systemic side effects and is safe for men and women. Does not have FDA approval. On their own Website, it states that it is "not a drug, medication, treatment, or cure for hair loss." It also claims internal study performed showed significant decrease in hair loss in 3 months.

RxProducts
Niwral^®, by Janssen Pharmaceuticals, is a shampoo containing ketoconazole 2% (an anti-fungal agent). Ketoconawle, taken in tablet form, has been shown to lower serum testosterone. The effect has been compared to that of minoxidil 2%. It is available in 1% form over-the-counter or in 2% form as a prescription.

Spironolactone is a potassium sparing diuretic, used in treatment for blood pressure, and has been found to have anti-androgen activity. It is a DHT blocker in topical form and must be applied daily followed by the application of a minoxidil solution. It is available by prescription in tablet or foam.

Devices/Other
Non-medical; Non-camouflage
LaserComb, by Lexington International, claims to use photobiostimulation with low-level, cold beam laser therapy. It claims to show improvements or activation of hair in the first 5-10 weeks. It requires usage twice a day for 10 minutes per session. It has had some mixed reactions. Some of the positive responses are from respondents using other forms of hair loss remedies. It has begun FDA clinical trials. It sells for $695.

Hairogenics^TM is a hair storage service in a temperature-controlled vault. The principle involves storing hair until cloning or other reproduction methods are viable. Concerns revolve around the extraction of hair and that DNA taken from existing hair would be sufficient for any cloning or reproducing possibilities. Based in Oregon, cost is an initial $50 plus $10 per annum for storage.

Dermal Fusion, by Ryan Livingston, claims to be a hair "multiplication" technique in which microscopic biopsies of hair or scalp tissue are removed without scarring or blood. Follicles are multiplied in a type of incubation chamber and a pipette then inserts surviving cells. The procedure claims immediate hair growth without any trauma or a resting phase. It is generally believed to be a hoax.

It is worth noting the similarity among most of these products in terms of their recommended treatment regimen and ingredients. Many of the so-called natural products actually contain minoxidil in some form, which is a clil1ically-proven hair loss remedy. Many of these "treatments" do not provide sufficient information on their formulations or will disguise some of their ingredients with terminology not usually recognized by the public. Almost unilaterally, there is a DHT-blocker listed, but with no identification. Clinical trials are alluded to, but not supplied in many instances; substantiation of claims is usually lacking. There is often no satisfactory mechanism of action that has been provided.

Summary
Over 50% of the male population has cosmetically significant male pattern hair loss in their 50s. There is pressure on individuals to look younger both socially and in the workplace. Society wants superior solutions and wants these solutions now. There is a growing interest in anti-aging treatments, herbal formulas, and holistic medicine. Businesses are attempting to take advantage of this demand. They offer products that are not efficacious and are misrepresented. Better education on the proven methods of treating hair loss is needed. Hair transplantation, Rogaine, and Propecia are the only clinically proven medical hair loss treatments. Until a new drug is found, cloning is perfected, or genetic therapy refined, they remain the best solutions for the hair loss population.

BIBLIOGRAPHY
1. Altcheck, Douglas, MD, Mt. Sinai School of Medicine, in Men's Health magazine, September 2002.
2. Nioxin product literature
3. Washenik, Ken, MD, PhD. "Pharmacologic Treatment of Androgenetic Alopecia," presentation 2002.
4. Wilt, et al. JAMA 280:1604-1609, 1998.
5. Goepel, et al. Prostate 38:208-215, 1999.

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