The cure for baldness is finally here: Doctors hail ‘gamechanger’ lotion with NO major side-effects or sex-drive impact that can regrow hair by more than 500pc. Special report by WILL STODDART

It saves very few, but can that dreaded men’s bald patch finally be defeated with lotion twice a day?

That’s the potential promise of two new clinical trials that found that a new treatment originally developed for acne increased hair growth by more than 500 percent in six months.

The results appear to be so positive that shares of Cosmo Pharmaceuticals, the company behind the new lotion, skyrocketed 40 percent in a single day in December.

Dermatologists call the lotion, clascoterone, a ‘game changer’ and the first real breakthrough in male pattern baldness in three decades.

Male pattern baldness, also known as androgenetic alopecia, is the most common type of hair loss, affecting 6.5 million men in the UK. It typically causes a bald patch on the top of the head or receding hairline and tends to run familially.

It is triggered by dihydrotestosterone (DHT), a derivative of the testosterone hormone, and gradually shrinks genetically sensitive hair follicles, making hair increasingly thinner. As a result, the hair growth mechanism in the follicle is completely turned off.

The new lotion aims to combat this in a completely different way than the pills and potions currently available.

Available treatments include minoxidil, better known by the brand name Regaine, available in foam or liquid form, which is thought to improve blood flow to hair follicles.

But it doesn’t work for everyone. About 40 to 50 percent of men experience limited benefit, and any gains are lost when the man stops using the treatment.

Other options include finasteride and dutasteride, pills that lower DHT levels; But since DHT also supports libido and prostate function, they come with potentially off-putting side effects, such as lower sex drive.

Clascoterone is different because it blocks the action of DHT within the follicle without causing these body-wide side effects.

The formula used is five times stronger than that used for acne (marketed under the brand name Winlevi). Second, it works by blocking the action of hormones in the skin’s sebaceous glands, reducing oil production and inflammation.

Two recent trials of clascoterone for baldness, called SCALP 1 and SCALP 2, involved 1,465 men in Europe and the US and are said to be the largest hair loss studies ever conducted for a topical treatment.

Each participant was applied either the new lotion or the dummy version. The effects were measured by photographing and counting hairs on a small, tattoo-marked spot on the scalp to compare the same patch each time.

After six months, one study showed a 539 percent improvement in hair count in those who used clascoterone lotion. The other study saw a 168 percent improvement, but no similar benefit was seen in men using artificial lotion.

Side effects were limited to mild skin reactions, including rash or itching (but these also occurred in men using the counterfeit product).

‘This is an important point, because concerns about libido, erectile function and mood pose significant barriers for many men considering using oral finasteride or dutasteride,’ says Professor Maria Hordinsky, head of the department of dermatology at the University of Minnesota, who led the trials.

‘Given how many men are affected and how many avoid treatment because existing options do not suit their needs, the prospect of a new, biologically targeted, well-tolerated topical treatment is truly exciting,’ he says.

Professor Desmond Tobin, a dermatologist at University College Dublin, believes the results are a ‘very significant improvement’, but notes that men ‘need to be committed to taking the treatment regularly and discontinuing treatment is likely to restart the balding process’.

Other experts advise caution in interpreting the results too much.

Professor Maria Hordinsky, chair of the dermatology department at the University of Minnesota, led the clascoterone trials.

‘The 539 percent figure can be very misleading if taken at face value,’ says Spencer Kobren, a hair loss specialist and founder of the American Hair Loss Association.

‘This doesn’t mean five times more hair. It just means that the treatment outperforms placebo in a very small, measured target area.’

But this may still be enough to satisfy some men, adds Professor Hordinsky. ‘Patients tended to see fuller coverage and better density in the target area, not just a few extra hairs on imaging,’ he says.

And most importantly, he says, men who use clascoterone notice a visible difference themselves.

Like all hair loss treatments, it works best early on when you begin to thin out rather than becoming completely bald.

Professor Hordinsky believes that those who will benefit most from this breakthrough include young men with early-stage hair loss, those who say no to finasteride for fear of side effects, and others who do not respond to minoxidil or actually want something that targets the underlying cause.

There is no treatment yet, available almost exclusively by prescription. Cosmo plans to apply for approval from medicines regulators in the US and Europe in the spring, meaning it could reach UK pharmacies later this year.

But Spencer Kobren has a warning.

‘When a hair loss treatment attracts media attention before it is widely available in pharmacies, we often see unregulated gray market versions quickly emerge,’ he says.

‘These products often have unknown concentrations, lack quality control and can put consumers at real risk.’ His advice is to wait for the truth.

This isn’t the only new hair loss treatment in the works.

Recent trials of a similar lotion called KX-826, which also blocks the effect of DHT on hair follicles, are ongoing, but so far it has not provided the same benefit as clascoterone. In the most advanced study, men using the drug grew more hair, but the increase was not significantly better than that seen with an artificial conditioner.

Another promising lotion is GT20029, which goes one step further than blocking male hormones. Instead, it is designed to break down the androgen receptor (the tiny ‘attachment point’ in hair follicles where male hormones attach and trigger hair thinning).

Available treatments include minoxidil, better known by the brand name Regaine, available in foam or liquid form, which is thought to improve blood flow to hair follicles.

In early trials, men who used it experienced increased hair count and fewer side effects. However, it is still several years behind clascoterone and much larger studies will be needed before it can be considered for approval.

Other promising ways to eliminate baldness include tablets used on the NHS to treat rheumatoid arthritis. Known as JAK inhibitors, these have been found to trigger new hair growth in men and women with alopecia Areata, a condition in which the immune system mistakenly attacks healthy hair follicles and affects around 400,000 people in the UK.

In 2024, the NHS approved the use of one of these drugs (ritlecitinib) for alopecia after studies showed that it blocked the action of enzymes that stop hair regrowth.

Even discarded umbilical cords may hold the secret to regrowth.

This is because they are rich in stem cells (mother cells that can differentiate into a number of different cell types) and, according to laboratory experiments, they have the capacity to support the growth of healthy new hair when implanted into the scalp.

A recent study published in Stem Cell Research & Therapy in China found that stem cells taken from the umbilical cord at birth stimulated the growth of human hair follicles in balding men. A trial is currently underway in the US to test the treatment, involving 100 men and women with hair loss.

For the first time in a generation, men worried about thinning hair may soon have something truly new to consider.