Hair Loss Treatments: A Word of Caution

More than 50% of the population of men in their 50s has cosmetically significant male pattern hair loss. No doubt, the pressure on individuals to look younger comes from all directions in our society. Also, our culture is impatient — we want superior solutions, and we want them now. All of these factors have converged over the past 2 years to drive the marked increase in the number of products promoted as solutions to hair loss. These formulations and devices pander to the population’s desire to find some way to halt this visible sign of aging. Wading through the myriad choices can be daunting enough for dermatologists — let alone for patients.

In this article, I’ll give you a good look at the treatment choices — Rx and over the counter — that your patients have available to them. By knowing what’s available, you’ll be better able to discuss appropriate options for your patients and steer them clear of treatments that may just be wasting their time and money.

Who Seeks Treatments
The latest statistics report that an estimated 80 million men and women are affected by hair loss in the United States. Yet, only 3% of this patient population searches out some sort of solution — whether it’s medical, surgical or non-medical. Only three medically proven methods of dealing with hair loss exist: 1. hair transplantation 2. minoxidil (Rogaine) 3. finasteride (Propecia). Of these, surgical hair transplantation is the only permanent solution to hair loss. Both minoxidil and finasteride are often successful options, but they require continued use to become and remain efficacious; once discontinued, hair loss ensues. Despite the availability of these proven methods, many people suffering from hair loss 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.

A Look Back
Historically, there have been two dramatic influxes of these types of products. The first began in 1988 and was spurred by the FDA approval of minoxidil. Copycat products could not offer clinical statistics to substantiate their claims and, eventually, the Federal Trade Commission (FTC) stepped in to regulate these products. The introduction of Rogaine 5% and Rogaine’s new over-the-counter (OTC) status in 1996 raised further awareness in the public, as did the introduction of finasteride (Propecia) in 1997. The second big wave of hair loss treatments came in December 2000 when Rogaine’s patent expired. A 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 dihydrotestosterone (DHT) inhibitors. Yet, Propecia is the only DHT inhibitor the FDA has approved for hair loss. Compounding the problem is that distribution of potentially bogus products has never been easier. Consumers can purchase them anonymously from numerous Internet sites, and the FTC has been slow to regulate efficacy of these unproven products, which hasn’t helped the matter. Here, I’ll take a look at the wide ranging category of hair loss treatments to give you a better idea of what’s available to your patients.

What Works

Minoxidil. As mentioned before, this was the first of the drugs approved for hair loss. Introduced in 1988, 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 OTC 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 endpoints.

Finasteride. The newest medication to be approved by the FDA for hair loss, this 5-alpha-reductase inhibitor was approved in 1997. The drug lowers DHT levels, resulting in hair maintenance and may result in hair growth. Clinical studies show that 90% of the study participants either gained or maintained their hair for more than 5 years compared to placebo.

Hair Restoration. This method offers the only permanent solution for hair loss. A surgical treatment, the procedure transplants viable hair from the donor area to the recipient locations. What’s Trendy Presently, the products generating the most interest are Avacor, Nioxin, Dutasteride and saw palmetto. Here’s a closer look at each.

Avacor. From Global Vision 2001, this heavily marketed product 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 immediately effective with results shown in 4 to 6 months. It’s a hair-growth stimulator based on a formulation of 2,4-di-amino-6d piperidino-pyrimidine 3 oxide, or in other words, minoxidil 2%. It also contains sabal serulate, an androgen modulator, commonly known as saw palmetto. While the company uses clinical data to support its claims, the data actually come from a “non-peer-reviewed, non-double-blind, seemingly scientific study subsidized by the makers of the product.”1 Average cost is $220 for a 3-month supply.

Nioxin. This product is a cleanser scalp therapy and scalp serum. It contains niocidin, which inhibits demodex-produced lipase.2 However, there has never been any study 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 upon bionutrient actives and protectives. The primary methodology of these agents 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. Available from GlaxoSmithKline, this is the most promising of the products or medications. Approved by the FDA only for use with prostate indication, 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, with slightly better results 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 are consistent with DHT reduction. The drug is still awaiting Phase III trials. Dutasteride has been marketed with the brand name Avodar.

Saw Palmetto. Available from multiple sources, this OTC herb has been touted as an effective supplement for helping 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 taking 400 mg of standardized extract with 100 mg of beta sitosterol daily. This product claims to produce results in 5 months. A Closer Look at the Other Popular Contenders There are numerous other products and devices available to the consumer. Here’s a random sampling of the most prominent lotions, potions and creams. I’ve categorized them by the operative mechanism or by their key, active ingredients. In this category, I’ll discuss products that are based on minoxidil, herbals, oils or vitamins.

Minoxidil-Based

• Folliguard Extra. Manufactured by Jungle MD, this product 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. Cost is approximately $200 for a 3-month supply.
• Hair Advantage. This product is from Daniel Rogers Laboratory, and it’s very similar to Avacor and Folliguard. This scalp detoxifying shampoo incorporates a DHT blocker and nutrient serum. The ingredients are composed of loniten (better identified as minoxidil), saw palmetto, tarakaci, notoptcryl, maidenhair tree, vaccinium murtillus and equisetum. Estimated cost is $180 for a 3-month supply. B>• Xandrox. This product also claims to contain a DHT blocker as well as a topical solution. Its active ingredients are minoxidil 12.5% micronized and azeleic acid 5% +/- betamethasone valerate. The company reports that the 12.5% micronized minoxidil works on temple and hairlines (non-responsive areas) while they say the azeleic acid can act as a DHT inhibitor.

Herbal Products

• Hair Genesis. This product, which is manufactured by 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. The shampoo employs “botanicals” to inhibit type I and II 5-alpha reductase and decrease DHT. The product claims to provide results in 6 months and is safe for men and women.
• Nu Hair. From Biotech Corp., this product 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. This product 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 claims that 9 out of 10 people have healthier hair growth.

Biologic Products

• Emu Oil. This substance has been studied by Boston University Medical Center and is a topical product that sells for $9.50 an ounce. Its credentials cite a Dr. Michael Holick who reported a clinical study that Emu Oil accelerated skin regeneration and stimulated hair growth. The product claims 80% of hair follicles began to grow hair in non-clinical studies.
• Thymuskin. Manufactured by Biotechne Complex Inc., this solution sells for $210 for a 3-month supply. This topical solution must be massaged directly into the scalp. It contains the extract of calf thymus glands and claims to boost immune function. However, product claims admit that it’s not effective for male pattern baldness or androgenetic alopecia, the most common types of hair loss.
• FNS. Otherwise known as Follicle Nutrient Serum, this product is from Osmotics and sells for $65 for a 4-ounce tube. It’s 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. This is marketed as a cosmetic product and will not be submitted for FDA approval. No trials have been performed to date.

Vitamin and Mineral Products

• Hair ZX. Available from Vitafree, this product sells for $250 for a 3-month supply. It is a three-part system including a shampoo, a topical and a DHT blocker. It’s available through Internet and direct sales. This product claims to regrow lost hair as well as produce larger, ealthier follicles.
• •Folligen. This product comes 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’s available through the Internet and direct sales. A copper-peptide-based product, this product’s functionality is based on the theory of increasing blood supply to the scalp to combat hair loss.
• Triaxon. This topical treatment is available through the Internet and direct sales. It contains a combination of vital nutrients and vitamins and reports it has a higher level of active ingredients designed to promote new growth. Product claims include helping to reduce DHT levels by 90% and giving users immediate results.
• EPM. From Sumitomo Electronics, this OTC topical treatment contains 10 amino acids. Its active ingredient is epimorphin. No clinical trial data are available, and this product isn’t available in the United States.

Miscellaneous Products

• Kevis. By Farmaka, this product sells for $650 to $975, depending upon the package you choose. It’s available through Internet and direct sales. The product includes a topical lotion, a shampoo and a topical “accelerator” that must be applied with an applicator and massaged into the scalp. The product claims to work by blocking DHT or the androgen receptor. The company indicates that clinical testing was conducted in Europe.
• Procyanidin B-2. This combination shampoo, lotion and primer is marketed as a regimen to deliver nutrients to the scalp. The agent, a polyphenol compound, is found in apples, which is said to act on hair epithelial cells as a growth-promoting factor. The company’s 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. Available from Advanced Skin and Hair, this product costs $99 for a 3-month supply. This OTC product includes a scalp therapy formula and bio-cleansing shampoo. The company claims that its product is an anti-DHT product and that it has no systemic side effects and is safe for men and women. On the Web site for this non FDA-approved treatment, the following is stated: This product is “not a drug, medication, treatment or cure for hair loss.” However, the company discusses an internal study that was performed that resulted in a significant decrease in hair loss in a 3-month period.

Rx Products

• Nizoral. This Janssen Pharmaceuticals’ shampoo contains ketoconazole 2% (an anti-fungal agent). Ketoconazole, taken in tablet form, has been shown to lower serum testosterone. The effect has been compared to that of minoxidil 2%. The shampoo is available in a 1% form over the counter or in 2% form as a prescription.
• Spironolactone. A potassium-sparing diuretic, this agent is used in treatment for blood pressure and has been found to have anti-androgen activity. It’s a DHT blocker in topical form, and it must be applied daily followed by the application of a minoxidil solution. This product is available by prescription in tablet or foam.

Devices and Other Options

• Laser comb. Manufactured by Lexington International, this $695 comb employs photobiostimulation with low-level cold beam laser therapy. The company claims to show improvements or activation of hair in the first 5 to 10 weeks. It requires usage twice a day for 10 minutes per session. The device has received some mixed reactions. Some of the positive responses are from respondents using other forms of hair loss remedies. FDA clinical trials with the device are underway.
• Hairogenics. This company offers a hair storage service, with hair being stored 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. This technique, developed by Ryan Livingston, claims to be a hair “multiplication” technique in which microscopic biopsies of hair or scalp tissue are removed without scarring or bleeding. Follicles are multiplied in a type of incubation chamber. A pipette then inserts surviving cells. The procedure claims immediate hair growth without any trauma or a resting phase. It’s generally believed to be a hoax. Summing Up the Options It’s worth noting that most of these products have similar recommended treatment regimens and ingredients. Many of the so-called natural products actually contain minoxidil in some form, which is a clinically proven hair loss remedy. Also, many of these treatments don’t provide sufficient information on their formulations, or they disguise some of their ingredients with terminology not usually recognized by the public. Almost unilaterally, many of these products list a DHT blocker but this ingredient may not be identified as such. Another thing many of these products also have in common is that they allude to clinical trials, but in many instances the specific data to substantiate the claims aren’t supplied. Lastly, there’s often no satisfactory mechanism of action provided within the product. With the population’s growing interest in anti-aging treatments, herbal formulas and holistic medicine and the perceived need to look younger, we’ll continue to see a slew of products that claim to effectively treat hair loss. Some may live up to their claims, but most are bound not to. We must be aware that many of our patients may be trying these products in vain, so the need for better educating them is paramount. Hair transplantation, Rogaine and Propecia are the only clinically proven medical hair loss treatments at present. Until a new drug is found, cloning is perfected or genetic therapy refined, they remain the best solutions for the hair loss population.