An experimental oral treatment for male pattern baldness has produced encouraging results in a late-stage clinical trial, with 86% of participants reporting improved hair coverage after six months.
US biopharmaceutical company Veradermics developed the drug, known as VDPHL01, as an extended-release version of oral minoxidil.
However, the treatment has not yet been approved by the US Food and Drug Administration. It remains under clinical development and is not commercially available.
The trial involved 519 men.
The Phase 2/3 trial enrolled 519 men with mild to moderate pattern hair loss, also known as androgenetic alopecia.
Researchers randomly assigned participants to three main groups.
One group received 8.5mg of VDPHL01 once daily. The other took the same dose twice daily. The remaining participants received a placebo.
The study used a randomized, double-blind, placebo-controlled design. This meant that neither the participants nor the investigators knew who was receiving the active treatment during the trial.
Up To 86% Reported Better Hair Coverage
Other subjects who tried the oral treatment measured their hair improvement using the Androgenetic Alopecia Impact Rating Scale. Of those taking the one-daily dose, 79.3% reported an improvement in hair coverage. For those who took the two-daily dose of the treatment, 86% of the subjects found they had better coverage.
Of the subjects who took the placebo treatment, only 35.6% saw an improvement.
Disclaimer
The study does not state that the treatment caused an 86% increase in hair coverage; it states that 86% of the test subjects had a better outcome with the twice-daily treatment regimen.
A subset of tests used “improvement” or “much improved” as criteria, and 48.4% and 62.9% of the once- and twice-daily groups, respectively, met that.
Just 13.4% of those in the placebo group met those criteria. Independent investigators looked at participants and found increased hair coverage with both once and twice-daily dosing, at 72% and 84.4% in respective groups after six months.
An oral drug offers extended-release of minoxidil. Minoxidil has been available as a high blood pressure medication and then as a hair regrowth drug that comes in topical forms for male pattern hair loss.
The medication has also been given by some doctors orally in a low dosage format, even though instant-release versions were never designed for hair loss. Instead of a new active drug, VDPHL01 involves a special extended-release composition of minoxidil, where it’s embedded within a matrix of gel. This, developers hope, will release the drug over longer time periods.
Current once or twice daily oral minoxidil quickly rises to maximum blood concentration levels and is then eliminated by the body in several hours.
“Continuous-release of minoxidil, we believe, could increase prolonged stimulation of hair follicles and allow for a flatter profile, thereby avoiding the plasma peak levels seen with immediate-release oral minoxidil that are associated with cardiovascular side effects,” a Veradermics press release stated. Of course, regulators must also review the complete results to determine if the new drug should be approved.