Category Archives: Female Hair Loss

Bicalutamide for Female Pattern Hair Loss

Bicalutamide Female Pattern Hair Loss
Bicalutamide to treat female pattern hair loss. Before and after 6 months of treatment with 50 mg per day. © 2020 by the American Academy of Dermatology, Inc.

Over the past several years, I have increasingly been hearing about an oral anti-androgen called bicalutamide (brand name Casodex). While originally approved to treat prostate cancer in 1995, it is becoming a popular option in treating female pattern hair loss (FPHL).

Bicalutamide is a nonsteroidal antiandrogen (NSAA). It is also called a selective androgen receptor (AR) antagonist. Among the skin and hair conditions that it is being used to treat include acne, hirsutism and female pattern hair loss. Bicalutamide was originally derived from a structural modification of flutamide.

Update: August 2023 — A new paper from Brazil on treating female pattern hair loss covers bicalutamide in detail.

Update: April 2023 — From yesterday’s ISHRS Webinar:

April 19, 2023

Bicalutamide for Female Pattern Hair Loss

A number of recent reviews, studies and presentations conclude favorably in regards to the use of oral bicalutamide to treat female pattern hair loss (FPHL).

  • In 2022, researchers from Brazil reviewed various studies and concluded that oral bicalutamide seems to be a promising option to expand the arsenal of FPHL treatment. They do point out the need for clinical trials to establish the ideal dose and efficacy of the drug.
  • At the 2022 ISHRS conference, Dr. Sergio Vañó Galván discussed two “new medications” to treat hair loss: bicalutamide and clascoterone (aka Breezula).
  • Moreover, at the same conference, Dr. Alba Gómez-Zubiaur had a presentation titled: “Mesotherapy with Bicalutamide: A New Treatment for Androgenetic Alopecia.” In April 2023, he published a study on this interesting mesotherapy delivery method for bicalutamide. Make sure to also read my post on mesotherapy and dutasteride.
  • In 2020, a group of Spanish researchers retrospectively reviewed all patients who were receiving oral bicalutamide (OB) for FPHL at their hair clinic between February 2018 and February 2020. A total of 44 women receiving OB 25-50 mg daily were included. They concluded that OB had favorable hair growth results and a very good safety profile, even when used in combination with oral minoxidil or spironolactone. One of their patient’s before and after photo is shown at the top of this post.
  • In 2020, a team from Australia led by Dr. Rodney Sinclair reviewed the safety results in 316 women treated with bicalutamide. Doses ranged from 5 mg per day to 50 mg per day. The vast majority of them were also using oral minoxidil or spironolactone. In general, the safety profile was excellent and the drug benefitted female androgenetic alopecia (AGA) patients. The few patients who got a mild elevation in liver enzymes saw no adverse symptoms.

Side Effects

Bicalutamide has no diuretic effect and it does not cross the blood brain barrier. In comparison to another popular anti-androgen called flutamide, bicalutamide has a much lower rate of liver toxicity. Moreover, unlike the former, the latter does not affect serum luteinizing hormone and testosterone levels.

Bicalutamide can cause a mild elevation of liver transaminases (enzymes), peripheral edema and gastrointestinal complaints in a very small percentage of users. These side effects are usually reversible. Overall, this medication seems to cause fewer side effects than Spironolactone, the most popular anti-androgen that is used for reducing hair loss.

Note that bicalutamide is often used as an antiandrogen in feminizing hormone therapy for transgender women. And also as a puberty blocker in adolescent transgender girls.

In 2017, the combination of bicalutamide and a birth control pill was evaluated in a phase III clinical trial for the treatment of severe hirsutism in women with PCOS. The combination was found to be significantly more effective than a birth control pill alone.

FDA Approves Histogen IND for Female Hair Loss

Histogen Hair Stimulating Complex HSC660
Histogen Hair Stimulating Complex HSC660 for Women.

Update: July 2, 2018 — Histogen has just kicked off Phase 1 trials for its female hair loss product HSC660. The below post was originally published in May 2018.

When it comes to the speed of progress in a company developing and bringing forth to market a hair loss product, the most disappointing company for me has been Histogen.

Replicel and Follica have also been major letdowns in their speed of progress, although the former is perhaps now reliant on its partner Shiseido for further progress. Follica has made some big statements via its new and improved website during the past year, fingers crossed. In earlier years, the biggest disappointments were Aderans and Intercytex.

Histogen Background

I first covered Histogen in 2013, just a few months after starting this blog. In that post, I said that Histogen’s “male hair loss product (Hair Stimulating Complex — HSC) is in phase 2 trials, while the female product is yet to enter phase 1 trials“. Around the same time, I happened to be in San Diego and even visited Histogen’s offices and very briefly talked to a key staff member. I am clearly into hair loss research (anywhere in the world).

Note that Histogen’s product supposedly increases hair count via the injection of key growth factors in the form of KGF, VEGF, follistatin, placental growth factor, angiogenin and hepatocyte growth factor.

Since that original post, I have covered Histogen numerous times on this blog, with most developments entailing either 1) Conference presentations from CEO Gail Naughton; or 2) Brief mentions of Histogen getting some new financing and funding. In one of my past posts about Histogen, someone from the company even replied to a reader comment on this blog.

The one exception to the above was this upbeat post from 2016, in which we learnt from Dr. Naughton that Histogen’s HSC treatment would be made available in Mexico first (in 2018). They were also planning to soon conduct a large-scale 330-person clinical trial in Mexico with a local partner. They were also close to getting a partner in China for further clinical trials.

In 2017, Dr. Naughton then said the following in an interview:

“The U.S. trials are planned to commence in 2018; we expect it to gain approval in Mexico first, perhaps in 2020, and then in the U.S. sometime after that.”

And now in April 2018, Dr. Naughton said:

“Naughton said Histogen also is moving toward a late-stage clinical trial in Mexico for use of its HCS in men for treating baldness.”

US FDA Approval for Histogen IND for Females

Earlier today, I got a bunch of alerts in my e-mail about Histogen. The big news is that the US FDA has just approved Histogen’s Investigational New Drug (IND) for Female Hair Loss Trial. For those who do not know, an IND is the first step before Phase 1 clinical trials, and primarily focuses on drug safety.

So 11 years after Histogen was founded, they are possibly soon entering Phase 1 clinical trials for their female hair loss product. Makes one want to cry, but perhaps they will be able to speed these trials up due to already having tested the product in males. In their latest press release, they call their Hair Stimulating Complex product “HSC660”.

The only reason I decided to write this post was because of the below encouraging paragraph from this latest press release:

“Pilot and Phase 1/2 Clinical Trials of an HSC660 predecessor were completed in male pattern baldness outside the US, with results that produced statistically significant efficacy indicators and a clear safety profile. More recently, a physician-sponsored 10 patient study in the US showed cosmetically significant results in both men and women. In addition to seeing a 100% female responder rate in the physician-sponsored study, previous trials have shown efficacy in other difficult-to-treat populations including men over 40 years of age and temporal recession hair loss”.