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19 de August, 2022
An ancient medicine helps fight baldness, experts say

Dermatologists who specialize in hair loss report that a key component of a topical treatment works even better when taken in small doses orally. Topical minoxidil is not always effective for patients who do not like the feeling of the product in the hair and, therefore, stop using it. However, the results are different when it is administered orally.

Ads are everywhere, along with exaggerated claims: there are shampo’s and special treatments, some costing thousands of dollars, that supposedly make hair grow. However, many dermatologists who specialize in hair loss claim that most of these products don’t work.” There are a plethora of ineffective hair growth drugs,” often at a “considerable cost,” says Brett King, a dermatologist at Yale School of Medicine, but adds, “Because people are desperate, these hair growth drugs continue to proliferate.” However, according to him and other dermatologists, there is an inexpensive treatment, which costs only a few cents a day, that restores hair in many patients. This is minoxidil, an old and well-known medicine to treat hair loss, but it is used differently. Instead of applying it directly to the scalp, it is prescribed in tablets in very low doses.

Although a growing number of dermatologists are prescribing minoxidil tablets in low doses, the treatment remains relatively unknown to most patients and many doctors. It has not been approved by the U.S. Food and Drug Administration (FDA) for this purpose, so it is prescribed outside of the guidelines set forth in its package insert, a common practice in the field of dermatology. “I call ourselves the ‘bad guys of unapproved products,’ a title I’m proud to use,” says Adam Friedman, professor and head of the Department of Dermatology at George Washington University. He explains that dermatologists are trained to understand how medications work, which allows them to test unapproved drugs. Often, in dermatology, it is clear whether a treatment is working: does the rash go away or not? Robert Swerlick, professor and chair of the Department of Dermatology at Emory University School of Medicine, agrees. “I tell people that most of what we prescribe is not approved, because this use is not established in the package insert,” he says. Swerlick lists a number of diseases, such as skin pigmentation disorders, inflammatory skin disorders and incessant itching, for which standard treatments are not approved according to the package insert.

Minoxidil, the active ingredient in Rogaine, a lotion or foam that is applied to the scalp, was first approved for men in 1988 and for women in 1992, and is now generic. The use of the drug in the treatment of hair growth was discovered accidentally decades ago. Minoxidil tablets in higher doses were used to treat high blood pressure, but patients often realized that the treatment made hair grow all over the body. Therefore, the manufacturer developed a minoxidil lotion (which turned out to be called Rogaine) and obtained approval to make hair grow on bald heads.

However, dermatologists claim that the lotion or foam is not always very effective for some patients, perhaps because they stop applying it. It needs to get to the scalp and the hair can get in the way. Many people, especially women, stop using it because they don’t like to leave the sticky substance in their hair. Johnson & Johnson, the company that currently owns Rogaine, did not respond to requests for comment. Others just think it doesn’t work for them. Minoxidil needs to be converted into an active form by sulfotransferase enzymes, which may or may not be present in sufficient quantity in the hair roots. When the drug is taken orally, it automatically converts into the active form. Still, that wasn’t the reason the low-dose pills were discovered, which also occurred by chance 20 years ago.

Rodney Sinclair, a professor of dermatology at the University of Melbourne in Australia, had a patient with female-pattern alopecia. The hair on the top of her head was less dense and she hated the way she looked. Unlike most of his patients, Rogaine worked, but he developed an allergic rash on his scalp due to the drug; However, if she stopped taking it, her hair would lose volume again.

“So I was in a dilemma,” Sinclair said. “The patient was very motivated, and the only thing we knew was that if a patient is allergic to a topical drug, one way to desensitize them is to give very low doses orally.”

To do this, Sinclair tried to cut the minoxidil tablets into four parts. To his surprise, the low dose made his hair grow but did not affect his blood pressure, which is the original goal of the drug at higher doses.

Subsequently, he reduced the dose more and more until he reached effective doses of one fortieth part of a tablet and began to prescribe the drug routinely. That first patient still takes it. At a meeting held in Miami in 2015, Sinclair reported that low doses of minoxidil caused hair to grow in 100 women in consecutive cases.

Sinclair published these results in 2017, where he noted that rigorous studies were needed in which some patients were randomly given minoxidil and others a sugar pill as a control, but that hasn’t happened yet. He said he has so far treated more than 10,000 patients.

Recently, a growing number of dermatologists specializing in hair loss have been prescribing minoxidil tablets in low dose to patients with male and female pattern hair loss, a common problem as one ages.

“Its popularity is starting to grow,” says Crystal Aguh, a dermatologist at Johns Hopkins University School of Medicine. “At conferences, we share our success stories more often.”

Doctors who don’t specialize in hair loss, she adds, “wouldn’t be familiar with oral minoxidil” except as a treatment rarely used to treat hypertension and that comes with a warning that it can cause heart problems. According to her and other experts, the warning refers to much higher doses.

If the hair loss is severe, minoxidil will not be effective, Aguh says. “For example, it won’t work if a man is almost bald, with a shiny scalp. There’s nothing to be restored.” It adds that the ideal patient is not completely bald, but has lost enough hair for even a casual observer to notice.

However, without a rigorous clinical trial leading to FDA approval, the use of minoxidil tablets for hair loss remains unauthorized for this purpose, and, according to dermatologists, is likely to remain so. “Oral minoxidil costs pennies a day,” King says. “There’s no motivation to spend tens of millions of dollars to be in a clinical trial. In reality, that study will never be conducted.”

Some patients who take low doses of minoxidil, however, notice the growth of unwanted facial hair. So some dermatologists, including Sinclair, have added another drug — very low-dose spironolactone, another blood pressure drug that also inhibits certain sex hormones called androgens — to prevent unwanted hair growth.

Patients who prefer to follow the label’s guidelines opt for over-the-counter medications, which some dermatologists say are ineffective, or one of two FDA-approved products for hair growth. These two products are Rogaine and finasteride, a generic drug used in higher doses by men to treat benign prostatic hyperplasia. As a treatment for hair loss, it is approved only for men. It has also been linked to sexual dysfunction.

Then there’s word of mouth about minoxidil in tablets. “I’ve seen miracles,” Aguh says. One was with Brandy Gray, who is 44 and lives in Monkton, Maryland. “Over time, I lost hair,” she says. “Then I started having circular areas,” with no hair. “They were getting worse and worse.” She had consulted another dermatologist who prescribed her shampoos and supplements, to no avail. Finally, he says his dermatologist told him, “There’s nothing else I can try with you, I can’t do anything else.” He consulted Aguh, who prescribed him minoxidil in low doses. Ten months later, her hair was thick and abundant. “I can comb my hair in a variety of ways,” she says. “I don’t wear wigs anymore.”

It’s like she’s never been through this hair loss.

Gina Kolata writes about science and medicine. She is a two-time Pulitzer Prize finalist and is the author of six books, including “Mercies in Disguise: A Story of Hope, a Family’s Genetic Destiny, and The Science That Saved Them.”

Brandy Gray, 44, was treated by Crystal Aguh before and after treatment with oral minoxidil.

By Gina Kolata
Published August 19, 2022 in The New York Times.

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