Old, cheap medicine makes hair grow, doctors say

Advertisements are everywhere — as are exaggerated claims: shampoos and special treatments, which sometimes cost thousands of dollars, will make your hair grow. But many dermatologists who specialize in hair loss say that most of these products don’t work.

“There are a plethora of useless remedies for hair growth,” often at “significant cost,” said Dr. Brett King, a dermatologist at the Yale School of Medicine. However, he added, “As people become desperate, these drugs remain plentiful.”

But there is an inexpensive treatment, he and other dermatologists, that cost just pennies a day, that restores hair in many patients. This is minoxidil, an ancient and well-known baldness drug used in a very different way. Instead of being applied directly to the scalp, it is being prescribed in very low dose pills.

Although a growing group of dermatologists are offering low-dose minoxidil pills, the treatment remains relatively unknown to most patients and many doctors. It has not been approved by the Food and Drug Administration (FDA) for this purpose and is therefore prescribed “off-label”—a common practice in dermatology.

“I call ourselves off-label thugs — a title I’m proud of,” said Dr. Adam Friedman, a professor of dermatology at George Washington University. He explained that dermatologists study to understand how drugs work, which allows them to try drugs that are not yet official. In dermatology, it is often unclear whether a treatment is working. Has the rash gone or not?

Dr. Robert Swerlick, a professor in the department of dermatology at the Emory University School of Medicine, agreed.

“I tell people most things we do are ‘off-label’ because there’s nothing ‘on-label’,” said the doctor, who provided a long list of conditions including skin pigmentation disorders, inflammatory disorders and itchiness, for which standard treatments are an alternative.

Minoxidil, the active ingredient in Rogaine, a lotion or foam that is rubbed into the scalp, was first approved for men in 1988, then for women in 1992, and is now generic. The drug’s use as a hair growth treatment was discovered by chance decades ago. High-dose minoxidil pills were being used to treat high blood pressure, but patients often noticed that the pills stimulated hair growth all over their bodies.

So its maker developed a minoxidil lotion — later called Rogaine — and got it approved for growing hair on baldheads.

But dermatologists say the lotion or foam isn’t particularly effective for some patients, perhaps because they stop using it. It has to penetrate the scalp, and the hair gets in the way. Many, especially women, stop using it because they don’t like to leave the sticky substance in their hair.

Johnson & Johnson, the current owner of Rogaine, did not respond to requests for comment.

Others find it just doesn’t work for them. Minoxidil must be converted to an active form by sulfotransferase enzymes which may or may not be present in sufficient amounts at the hair root. When the drug is taken orally, it is automatically converted into an active form.

But that’s not why low-dose pills were discovered. The discovery also occurred by chance 20 years ago.

Dr. Rodney Sinclair, professor of dermatology at the University of Melbourne in Australia, had a patient with female pattern baldness. The hair on top of her head had thinned, and she hated the way she looked. Unlike most of Sinclair’s patients, Rogaine worked for her, but she developed an allergic scalp rash from the drug. However, if she stopped taking it, her hair would get thin again.

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

To do this, Sinclair tried cutting minoxidil pills into quarters. To her surprise, the low dose made her hair grow, but did not affect her blood pressure, the original purpose of the higher dose drug.
Then he lowered the dose lower and lower until he reached one fortieth of a pill, and began routinely prescribing the drug. That first patient is still taking it.

At a meeting in Miami in 2015, Sinclair reported that low doses of minoxidil stimulated hair growth in 100 successive women.

He published these results in 2017, noting that rigorous studies were needed, in which some patients would be randomly assigned to take minoxidil and others a sugar pill. But that didn’t happen. He said he has treated more than 10,000 patients.

Recently, an increasing number of dermatologists who treat baldness have been giving low-dose pills to patients with male and female pattern hair loss, a normal occurrence with age.

“It’s just starting to increase in popularity,” said Dr. Crystal Aguh, a dermatologist at Johns Hopkins University. “We are increasingly sharing our success stories at conferences.”

Doctors not specializing in baldness, she added, “would not be familiar with oral minoxidil” except as a rarely used treatment for high blood pressure that comes with a warning that it can cause heart problems. But, according to her and other professionals, the warning is for much higher doses.

If the hair loss is very severe, minoxidil won’t help, Aguh said. “It won’t work, for example, if a man is nearly bald, with a shiny scalp. There’s nothing to restore.” She added that the ideal patient is not completely bald, but has lost enough hair for even a casual observer to notice.

Without rigorous testing leading to FDA approval, however, the use of minoxidil baldness pills remains off-label. And, according to dermatologists, it is likely to stay that way.

“Oral minoxidil costs pennies a day,” King said. “There’s no incentive to spend tens of millions of dollars to test it in a clinical trial. That study will never really be done.”

unwanted hair

Some patients who take minoxidil in low doses, however, notice stray hairs growing on their faces and chins. So some dermatologists, including Sinclair, have added another drug — very low doses of spironolactone, a blood pressure drug that also blocks certain sex hormones called androgens — to try to stop unwanted hair growth.

Patients who don’t want to go the “off-label” route are left with what some dermatologists say are useless drugs or one of two FDA-approved hair growth products.

They include Rogaine and finasteride, a generic drug used in higher doses in men to treat a benign enlarged prostate. As a hair loss medication, it is only approved for men. It has also been linked to sexual dysfunction.

Then there’s word of mouth about minoxidil in pill form.

“I’ve seen miracles happen,” Aguh said.

One involved Brandy Gray, 44, who lives in Monkton, Maryland.

“I had been losing hair for a while,” she said. “Then I started having circular spots” without hair. “They got worse and worse.”

Gray had seen another dermatologist who had given him shampoos and supplements, to no avail. Finally, she said, her dermatologist told her, “There’s nothing else I can try for you, nothing I can do.”

She went to Aguh, who gave her low-dose minoxidil. Ten months later, her hair was thick and thick.

“I can part my hair in different ways,” she said. “And I don’t wear wigs anymore.”

It’s as if the hair loss never happened.

^{Translated by Luiz Roberto M. Gonçalves}