New treatment for hair loss shows promise — paid volunteers needed to test it out

Head’s up!

A brand new potential remedy for androgenetic alopecia, also called male sample baldness, is making waves as a nationwide medical trial to check its security and effectiveness will get underway.

Proponents are abuzz about VDPHL01, a non-hormonal tablet that reveals promise in restoring hair with out the effort of topical therapies and the doubtless critical unintended effects of hormonal remedy.

“I emphasize non-hormonal as a result of the one FDA-approved oral remedy for sample hair loss has a hormonal mechanism of motion and is related to potential hormonal unintended effects like erectile dysfunction, decreased libido and suicidal ideas,” Dr. Neil Sadick instructed The Publish.

“Topical choices additionally typically have excessive discontinuation charges as they are often messy and cumbersome to use,” added Sadick, a medical professor of dermatology at Weill Cornell Medical Faculty.

There’s no treatment for androgenetic alopecia even because it impacts over 80 million People. The US Meals and Drug Administration has authorized topical minoxidil (also called Rogaine) and oral finasteride (model title Propecia) to deal with hair loss.

Right here’s what you must learn about VDPHL01.

What’s VDPHL01?

VDPHL01 is hawked by Veradermics, a biopharmaceutical firm based mostly in New Haven, Conn., which introduced in December it raised $75 million to fund the brand new trial.

Veradermics not too long ago developed a “modified launch” oral minoxidil pill. Sadick declined to say if VDPHL01 comprises minoxidil.

“The trial sponsor, Veradermics, is selecting to not disclose further details about the drug formulation right now,” Sadick mentioned.

“I can let you know that VDPHL01 has a novel profile in contrast to present FDA-approved therapies, that are related to cardiac exercise and undesirable sexual unintended effects,” he continued.

VDPHL01 is being studied as a once- or twice-daily tablet. Sadick mentioned preliminary Part 2 information revealed hair development as early as two months after remedy. This “encouraging” information needs to be obtainable within the coming months, he famous.

Veradermics expects to file for an approval inside a yr of completion of its trials — in the event that they go effectively.

How does VDPHL01 differ from different therapies?

Finasteride, which is bought as Proscar or Propecia, was authorized by the FDA within the ’90s. An estimated 2.6 million folks took finasteride in 2022.

The tablet prevents testosterone from turning into one other hormone referred to as dihydrotestosterone (DHT). Excessive ranges of DHT may cause hair follicles to shrink, resulting in hair loss.

Whereas finasteride reduces hair loss and promotes hair development, it’s meant just for males and might trigger erectile dysfunction, decreased intercourse drive and despair, amongst different potential unintended effects.

The FDA, in the meantime, authorized oral minoxidil within the ’70s to deal with hypertension and topical minoxidil within the ’80s for hair loss.

Minoxidil will increase blood circulate to hair follicles, stimulating hair development.

Uncomfortable side effects of the OTC med embrace scalp irritation, undesirable facial hair development, chest ache, quick heartbeats and dizziness.

When requested about VDPHL01’s potential unintended effects, Sadick mentioned that dialog is “greatest had between a examine investigator and a possible trial participant.”

Who can take part within the VDPHL01 trial?

Sadick’s Manhattan workplace, Sadick Dermatology, is one among 44 US websites concerned within the Part 2/3 medical trial of VDPHL01.

The objective is to enroll about 480 males throughout all examine websites.

Sadick is looking for wholesome males between 18 and 65 residing within the NYC space and experiencing sample hair loss. Candidates have to be keen to maintain their hair at the least a quarter-inch lengthy all through the examine.

These chosen will likely be compensated for his or her participation, which entails 13 visits to Sadick Dermatology over roughly 13 months. Enrolled sufferers will obtain VDPHL01 or a placebo. Go to phlstudy.com or name (212) 772-7242 for extra info or to enroll.

VDPHL01 can be being studied in girls, with a Part 3 medical trial anticipated to begin later this yr.