NEW YORK.- The ads are everywhere, as are the exaggerated claims: there are shampoos and special treatments, sometimes thousands of dollars, that make hair grow. Neverthelessmany dermatologists specializing in hair loss say that most of these products do not work.
“There are endless useless hair-growth remedies,” often at “considerable cost,” said Brett King, a dermatologist at Yale School of Medicine, but, he added, “because people are desperate, these hair-growth remedies hair growth continue to abound.”
However, according to him and other dermatologists, there is an inexpensive treatment that costs pennies a day and restores hair in many patients. Its regarding minoxidilan old and well-known drug for the treatment of hair loss that is used in a very different way. Instead of applying it directly to the scalp, it is prescribed in very low-dose pills.
Although a growing group of dermatologists offer low-dose minoxidil pills, the treatment remains relatively unknown to most patients and many doctors. It has not been approved by the US Food and Drug Administration (FDA, for its acronym in English) for this purpose, so it is prescribed outside of what is indicated in its data sheet, a common practice in the dermatology sector.
“I call ourselves the bandits of unapproved products, a title I am proud to usesaid Adam Friedman, professor and chair of dermatology at George Washington University. He explained that dermatologists have been trained to understand how medications work, allowing them to test unapproved drugs. Often in dermatology it becomes clear whether a treatment is working: does the rash fade or not?
Robert Swerlick, professor and chair of the department of dermatology at Emory University School of Medicine, agreed. “I tell people that most of what we prescribe is off-label because that use is not stated on the label“, said. Swerlick offered a long list of conditions, such as skin pigmentation disorders, inflammatory skin disorders, and incessant itching, for which standard treatments are not approved according to his label.
Minoxidil, the active ingredient in Rogaine, a lotion or foam that is rubbed onto the scalp, was first approved for men in 1988, then for women in 1992, and is now generic. The use of the drug as a treatment for hair growth discovered by accident decades ago. High-dose minoxidil pills used to treat high blood pressure, but patients often found that the pills caused hair growth all over their bodies. So its manufacturer developed a minoxidil lotion (which ended up being called Rogaine) and got it approved for growing hair on bald heads.
However, dermatologists say that the lotion or foam not very effective for some patients, perhaps because they stop using it. It has to get to the scalp itself and the hair gets in the way. Many people, especially women, stop using it because they don’t like leaving the sticky substance in their hair.
Johnson and Johnson, the company that currently owns Rogaine, did not respond to requests for comment.
Others feel that it just doesn’t work for them. Minoxidil has to be converted into an active form by sulfotransferase enzymeswhich may or may not be present in sufficient amounts at the roots of the hair. When the drug is taken orally, it automatically assumes an active form.
However, that was not the reason why low-dose pills were discovered, rather the discovery also happened by accident 20 years ago.
Rodney Sinclair, a professor of dermatology at the University of Melbourne, Australia, had a patient with female pattern hair loss. The hair on the top of her head had thinned and she hated the way she looked. Unlike most of her patients, the Rogaine worked for her, but she developed an allergic scalp rash from the medication; however, if she stopped taking it, her hair would thin once more.
“So I was in a dilemma,” Sinclair said. “The patient was highly motivated, and all we knew was that if a patient is allergic to a topical medication, one way to desensitize them is to give them very low doses orally.”
To do so, Sinclair tried cutting minoxidil pills into quarters. To his surprise, the low dose caused his hair to grow, but did not affect his blood pressure, which is the original goal of the drug at higher doses.
Subsequently, he lowered the dose further and further until he reached effective doses of one fortieth of a pill and began prescribing the drug routinely. That first patient is still taking it.
In a meeting held in Miami in 2015Sinclair reported that low doses of minoxidil caused hair growth in 100 women, which were consecutive cases.
Sinclair public those results in 2017, where he noted that rigorous studies were needed in which some patients were randomly prescribed minoxidil and others a sugar pill, but that has not happened. He said that so far he has treated more than 10,000 patients.
Recently, an increasing number of dermatologists specializing in hair loss have been prescribing the reduced-dose pills to patients with male and female pattern hair loss, a normal occurrence with aging.
“The popularity is starting to pick up,” said Crystal Aguh, a dermatologist at Johns Hopkins School of Medicine. “At conferences, we share our success stories more and more often.”
Doctors who don’t specialize in hair loss, he added, “would not be familiar with oral minoxidil” except as a very infrequently used treatment for hypertension and that it comes with a warning that it can cause heart problems. According to her and other specialists, the warning is for much higher doses.
If hair loss is severe, minoxidil won’t help, Aguh said. “For example, it won’t work if a man is mostly bald, with a shiny scalp. There is nothing to restore.” He added that the ideal patient is not completely bald, but has lost enough hair for even a casual observer to notice.
However, without rigorous testing leading to FDA approval, minoxidil pills for hair loss remain off-label for that useand, according to dermatologists, it probably will continue to be so.
“Oral minoxidil costs pennies a day,” King said. “There is no motivation to spend tens of millions of dollars to test it in a clinical trial. In reality, that study will never be done.”
Some patients taking low doses of minoxidil, however, notice stray hairs growing on their face and chin. So some dermatologists, including Sinclair, have added another drug—very low-dose spironolactone, another blood pressure medication that also inhibits certain sex hormones called androgens—to prevent unwanted hair growth.
Patients who don’t want to go the off-label route are stuck with what some dermatologists say are useless over-the-counter remedies or one of two FDA-approved hair growth products.
These two products are Rogaine and finasteride, a generic drug used in higher doses in men to treat benign enlargement of the prostate. As a medicine for hair loss, it is approved only for men. It has also been linked to sexual dysfunction.
Then there is word of mouth regarding minoxidil in pill form.
“I have seen miracles,” Aguh said. One of them was with Brandy Gray, who is 44 years old and lives in Monkton, Maryland. “Over time I have been losing my hair,” she said. “Then I start to have circular holes”, without hair. “They just kept getting worse and worse.” He had consulted with another dermatologist who gave him shampoos and supplements, without success. Finally, he says that his dermatologist told him: “There is nothing I can try for you anymore, I can’t do anything else.” She went to Aguh, who prescribed low-dose minoxidil. Ten months later, her hair was thick and abundant. “I can style my hair in different ways,” she said. “I don’t wear wigs anymore.” It’s like she never experienced such hair loss.
Por Gina Kolata
