More Questions than Answers from Polichem’s Latest Report

It’s not always easy to figure out whether information coming from pharmaceutical companies is promising or should be considered a setback. That was the case in recent weeks as the hair loss community has tried to decipher information released by the Swiss company, Polichem, related to its Phase III clinical trial of P-3074. That’s the working name for the topical finasteride compound Polichem has been developing and testing for years.

This spring the company published, Study to Evaluate the Efficacy and Safety of P-3074 Topical Solution in the Treatment of Androgenetic Alopecia, which reported findings from its trial. It was a bit unusual, however, because the published results lacked a written analysis or conclusion. As a result, interested people who have been following the Polichem’s progress were left to sift through the information and come up with their own range of possibilities.

Based on our review of the information provided, Polichem’s clinical trial has determined that P-3074 performed no better and no worse than finasteride taken orally. There wasn’t a statistically significant difference between Polichem’s topical solution and the conventional approach of a 1 milligram tablet taken daily – either in terms of slowing hair loss and achieving hair regrowth, and in terms of side effects.

On the one hand, that’s good news. We’ve known for more than 20 years that finasteride is effective in treating hair loss. It is a synthetic compound that blocks the activity of 5-alpha-reductase, an enzyme essential in converting testosterone to the more potent dihydrotestosterone (DHT), which can contribute to male patter baldness.  Finasteride reduces scalp DHT by 64 percent and serum DHT by 68 percent. It’s one of only two medications (along with minoxidil) approved by the FDA for that purpose.

So, if there is a breakthrough here it is that Polichem has confirmed that finasteride paired with Hydroxypropyl-Chitosan (which creates a film to assist delivery) can be effective when applied directly to the scalp.

However, as others have pointed out, there are some aspects of what has been released about the study design that are less than ideal. The biggest mystery is that side effects were all self-reported through a survey the subjects in the study completed after weeks four, eight, 12 and 24. They were asked four questions to evaluate their sexual function and activity on a scale of zero to five. It’s not a huge surprise that pretty much everybody is generally satisfied with their own sexual performance! All three groups in the study – those taking P-3074, those taking oral finasteride and those taking a placebo – reported similar ratings.

It’s worth backing up here for a moment to explore the original rationale for exploring topical finasteride. It started with the theory that a topical application would diminish, or hopefully even eliminate, the side effects that some men experience with the medication. Since it would be applied directly to the scalp, perhaps Polichem’s P-3074 could deliver a lower dose. P-3074 contains 0.25 percent finasteride versus the 1 mg found in tablet form.

Given the findings reported to date, it would be a stretch to interpret this as anything other than a disappointment. If the topical formula performs the same as the pill, why would Polichem continue going down this path?

Here’s one possible reason for continuing to push forward: Knowing that there is a small percentage of men who do experience side effects from finasteride, why not specifically target the testing to them? Instead of thinking of P-3074 as a possible replacement for the pills, maybe it could serve as an alternative for those who experience side effects from the pills. It seems like you would only be able to compare its effectiveness and safety for this population if the testing is focused narrowly on this population.

One other note: we at Arocha Hair Restoration have learned that some do-it-yourselfers have approached compounding pharmacies about having their own topical finasteride solutions created. As this latest data indicates, there is no evidence to suggest a topical solution is better than the pill. These types of experiments are nothing to fool around with and could be harmful.