Category Archives: Almirall

Topical Finasteride Finally Here in Europe

Topical Finasteride
Topical Finasteride.

I have covered topical finasteride at least ten times on this blog. My original post on this subject came in 2014, and was updated in February 2020.

I have especially emphasized Polichem’s P-3074 (now Almirall’s ALM12845) hydroxypropyl chitosan (HPCH)-based topical finasteride. This product is now finally being released in the European Union countries. Note that besides chitosan, there are many other potential delivery systems for topical finasteride.

Unlike specialized topical finasteride products offered by local compounding pharmacies or hair clinics, Almirall’s ALM12845 has undergone rigorous three-phase clinical trials. For more information, see Phase 3 trial results of P-3074 as well as this 2015 encouraging update.

Note: I am even more interested in topical Dutasteride for male pattern hair loss.

Will Topical Finasteride have Fewer Side Effects?

Due to some people getting persistent side effects from oral finasteride, the interest in topical finasteride is extremely high. While there are no guarantees when it comes to fewer side effects from topical finasteride, it is a virtual certainty that there will not be higher rates of side effects.

Speaking for myself, it does give me peace of mind to use something topically rather than ingesting something orally. Moreover, with the topical product, one can use a lot less than the recommended dosage. If you are only losing hair in the crown region, you might start by applying a bare minimum of the spray or lotion in that area.

This is a lot more desirable than ingesting a whole pill. Breaking tiny 1 mg finasteride (Propecia) pills into even smaller pieces and trying to distribute the resulting dosage evenly is not practical. Make sure to also read my post on finasteride and dutasteride dosage discussion.

Note that Hasson & Wong in Canada has been prescribing its own topical finasteride for a number of years, but they have not had to undertake any clinical trials. They use a local compounding pharmacy as well as Farmacia Parati (Italy) to make their product. In the past, they told me that the topical product has fewer side effects than the oral product.

A number of other hair transplant clinics nowadays offer proprietary combination topical products that contain both finasteride and minoxidil. Some doctors prefer oral finasteride to topical for generalized hair loss.

Serum, Plasma and Scalp DHT Level Reduction

Research on dihydrotestosterone (DHT) level reduction by topical finasteride shows varying results. This is obviously impacted by the type of compounded product being used, dosage amount and application frequency.

One study of P-3074 found scalp DHT levels declined by 70% with once a day application of 1 ml (2.275 mg) of P-3074 topical finasteride. By comparison, oral finasteride 0.5 mg/day reduces scalp DHT levels by around 50-70 percent (different results in different studies). However, the P-3074 study showed 50 percent scalp DHT reduction when using lower doses.

Serum DHT was reduced by 60 -70 % for the 1 ml dose of P-3074. Similar to what is seen with oral finasteride. But only 25 percent with the 100 and 200 μL doses; and around 45 percent with the 300 and 400 μL doses.

Interestingly, no relevant changes occurred in serum testosterone readings. By contrast, oral finasteride changes both testosterone and estrogen levels.

Almirall will release ALM12845 in Europe in 2021

A few months ago, I contacted Almirall and they told me that they would release their topical finasteride ALM12845 (or ALM-12845) in Western Europe in 2021. The release date would vary by country. No plans for selling in the US market.

One of this blog’s readers (“Paul”) e-mailed them after me, and he was given the more specific release date statement below:

“Without going beyond the limits of confidentiality, I can confirm you that we expect to launch topical Finasteride by the beginning of 2021 in Europe once the assessment by Health authorities is completed.”

Earlier today, reader “Lesley” made an important discovery. She posted this recent link from Gazzeta Ufficiale (Italy). It has the English translation of part of the content from this pdf. I will discuss the content in more detail further below.

Difa Cooper’s Caretopic Topical Finasteride

Per the above news, it seems like Italy based Difa Cooper (also known as Cantabria Labs Difa Cooper) will produce Almirall’s ALM12845. Per “Lesley”, they will only market it in France and Germany. I cannot tell for sure, but makes sense per below image.

In January 2020, Almirall announced that ALM12845 no longer fits its strategic portfolio. At the time, the company had started looking for a partner to out-license the product. The first partner is now likely Difa Cooper. I am guessing that they will need more partners in other European countries.

Per the earlier mentioned Gazzeta link:

  • The topical finasteride (brand name “Caretopic“) will be in “cutaneous spray, solution” form.
  • Each ml of the solution will contain 2.275 mg of finasteride. Each bottle will contain 18 ml.
  • Each dispersion (spray) amounts to 50 μl, which contains 114 micrograms of finasteride.
Almirall Topical Finasteride (Difa Cooper)
Announcement that Almirall’s topical finasteride ALM12845 will be sold by Difa Cooper. Under the brand name “Caretopic”.

Topical Finasteride Here by 2021

I originally wrote this post on topical finasteride in June 2014. Updated on February 22, 2020.

Almirall ALM12845

It finally looks like Spain-based Almirall will release its ALM12845 topical finasteride in 2020 or early 2021. Note that this product was previously known as Polichem’s P-3074. Almirall purchased Polichem in 2015.

The company filed for a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in September 2019. The ALM12845 product is described as a cutaneous spray solution for the topical treatment of men with androgenetic alopecia. First national phase approval is expected in 2020 or early 2021. I am not sure if they will be able to get FDA approval to market in the US as yet. The pipeline chart below only shows an EU flag:

Almirall ALM12845 Topical Finasteride.
Almirall ALM12845 topical Finasteride.

Topical Finasteride for Hair Loss

Recent reports suggest that topical finasteride results in similar increases in hair count compared to oral finasteride. Topical finasteride is typically compounded in gel or solution form. The oral version can come in pill, capsule or tablet form. It is hoped and likely that the topical version has fewer side effects than the oral version.

2018 update: A systemic review of topical finasteride shows consistent reduction in hair loss. Both scalp and plasma DHT levels decreased significantly.

Topical Finasteride
Topical finasteride for hair loss.

The manufacturer of Propecia (Merck) applied for a patent for topical finasteride in 2002. However, the company has to date never tried to develop an actual product. This is all the more surprising when considering that Propecia has been getting significant negative publicity of late. Many users suffering from long-term sexual side effects have filed a class-action lawsuit against Merck.

Polichem’s P-3074

I am writing this post today because an important clinical trial/study for P-3074 was just completed in Switzerland. 2019 Update: P-3074 final trial results are now published.

P-3074 is a new topical finasteride solution with hydroxypropyl-chitosan as the film-forming agent. The study was funded by Swiss company Polichem, which primarily specializes in dermatological and gynecological products.

The interesting thing about this study is that four different doses (ranging from 0.25 mg to 1 mg) of topical finasteride were tested. The study entailed 32 human participants, with 8 of those 32 getting a placebo dose. One negative thing about the study is that only a 7-day dose of the topical P-3074 solution was administered. There will therefore be no long-term measurement of the effectiveness of P-3074. It will be interesting to see the results of this study regarding yet another new hair loss product.

Note that a similar trial (although at just one dosage level of 0.25 mg per day) for P-3074 was conducted in the past. Its findings were presented last year at the 7th World Congress on Hair Research (WCHR 2013). The conclusion of this trial was quite significant:

“These findings show that DHT concentration in the scalp, after 7-day treatment course of P-3074 once daily, was more reduced (about 40%) than after 1 mg oral finasteride administration for the same treatment period.”

Topical Finasteride Side Effects

The main reason that people are so excited about topical finasteride is because of potentially fewer side effects in comparison to oral finasteride. Serum dihydrotestosterone (DHT) inhibition in the blood is significantly less with topical finasteride versus oral finasteride. At the same time, scalp DHT inhibition will remain similar with both delivery mechanisms.

However, it should be noted that different formulations will result in different levels of DHT inhibition. It is therefore imperative to be very careful if you are purchasing this product from any compounding pharmacy. Some of the below collected sources indicate that sexual side effects will be less likely with topical finasteride. At the same time, hair growth benefits will be similar for oral versus topical.

References and Studies

There have been other studies done in the past that concluded favorable results from topical finasteride. For example, a 2009 study from Iran concluded: “the therapeutic effects of both finasteride gel and finasteride tablets were relatively similar to each other.” Nothing is mentioned regarding side effects in the abstract of that study.

A more recent 2012 study from Thailand concluded that a 3% minoxidil plus 0.1% finasteride lotion (“MFX”) was superior to just 3% minoxidil (“MNX’). There is also an increasing amount of new research on better ways to deliver topical hair loss drugs, especially via nanocarriers.

Update: April 2020 — A new study found topical finasteride to be more effective than topical 17α-estradiol in women suffering from female pattern hair loss (FPHL).

It should also be noted that the original Merck patent for Propecia has a number of sentences mentioning topical formulations as also likely being effective.

What I am really hoping for are future studies on topical dutasteride. The main reason for this, besides dutasteride’s superior results to finasteride, is that type I 5α-reductase isoenzymes are more prevalent on the scalp. Type II 5α-reductase isoenzymes are more prevalent in the prostate.

Finasteride primarily inhibits type II 5α-reductase, while dutasteride also inhibits type I 5α-reductase. I would therefore not be surprised if topical dutasteride’s superiority over topical finasteride is even greater than the superiority of dutasteride pills over finasteride pills. Hopefully, there will also be fewer side effects even after accounting for some systemic absorption via the scalp.

A few hair transplant surgeons have developed their own topical finasteride solution, usually in partnership with local pharmacies. If you happen to have heard more on this, please post in the comments section below this post. Some hair loss forum participants seem to have tried to develop their own topical finasteride or even topical dutasteride. Something I would not recommend. The science of topical medication delivery is a bit too complex for the vast majority of us to be experimenting with on ourselves.

Other Sources of Topical Finasteride

A number of clinics and many local pharmacies can already compound topical finasteride for you. However, such localized products will never be substantiated by clinical studies, as is the case with Almirall’s product. Moreover, a large company such as Polichem has devoted years of research in perfecting its drug delivery system. They also have to prove limited to no side effects from their product during the rigorous clinical trial phases.

Update: I got an e-mail from the Hasson & Wong clinic on June 17, 2014 stating the following:

“Dr. Hasson is prescribing topical finasteride to some of his patients and it is being prepared at a pharmacy close to our clinic. To date the results have been very similar to the oral finasteride.”