Category Archives: Female Hair Loss

FDA Approves Histogen IND for Female Hair Loss

Update: Histogen has just kicked off Phase 1 trials for its female hair loss product HSC660. (h/t John Doe). The below post was originally published in May 2018. Also see this 2011 study on Histogen’s Hair Stimulating Complex (HSC). Dr Gail Naughton is a co-author.

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 (at least since I first started writing this blog).

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 movement, while the latter has made some big statements via its new and improved website during the past year.

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.

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.

Women’s Hair Loss Resources

Around 45 percent of this blog’s readership consists of females. One would never guess that number when considering the fact that 90 percent of the comments to my posts are made my men (and almost 100 percent of the foolish comments are accounted for by men). I will probably update this post in more detail in the coming months (or create new posts on subjects related to women’s hair loss treatments), but wanted to create this one asap in order to acknowledge the neglected 45 percent.

Cleveland Clinic Hair Loss in Women.

Harvard University Treating Female Pattern Hair Loss.

Women’s Hair Loss Forums

On most of the major English language men’s hair loss forums, there are also women’s hair loss sub-forums if you scroll down a bit. There are also various separate women’s hair loss forums out there. Below I list the most active and useful ones:

Her Alopecia Hair Loss Forums

Women’s Hair Loss Project Forums

Soul Cysters Women’s Hair Loss Forums (for women with PCOS)

Hair Loss Talk Women’s Hair Loss Forums

Bald Truth Talk Women’s Hair Loss Forums

Groundbreaking Female Hair Loss Researchers

I have mentioned before that an increasing number of hair loss researchers are now female. They still account for a minority of all researchers, but the trend in most fields of study nowadays is that women are becoming increasingly more represented. A select few of the below female researchers perhaps also have their own practice and are seeing new patients in case you want to try contacting them. I would assume that all of them are especially experienced in advising female patients. Note that I have covered virtually all the below researchers on this blog before, and you can use the search box at the top for more information on each person.

Dr. Elaine Fuchs — She is a legend in the hair loss research world (New York, NY).

Dr. Angela Christiano — another legend in the hair loss research world, and wears a wig so has a personal interest in finding a cure. She has been the most widely covered on TV (New York, NY)

Dr. Claire Higgins — yet another hugely important person in the hair loss research world (London, United Kingdom)

Dr. Valerie Randall (Bradford, United Kingdom)

Dr. Gail Naughton (San Diego, CA)

Dr. Ksenia Gnedeva (San Diego, CA and possible also Moscow, Russia)

Dr. Valerie Horsley (New Haven, CT)

Dr. Ekaterina Vorotelyak — (Moscow, Russia)

Dr. Sarah Millar (Philadelphia, PA)

Dr. Maria Hordinsky (Minneapolis, MN)

Dr. Jennifer Kloepper (Lübeck, Germany)

Dr. Ulrike Blume-Peytavi (Berlin, Germany)

Dr. Annika Vogt (Berlin, Germany)

Dr. Antonella Tosti (Miami, FL)

Dr. Wilma Bergfeld (Cleveland, OH)

Dr. Mayumi Ito (New York, NY)

Dr. Elise Olsen (Durham, NC)