Keramedix and Keratin Injections for Hair Growth

Yet another new company in South Korea called KeraMedix (or Keramedics) is set to begin hair growth related clinical trials. They applied for approval today and this process usually takes one month in South Korea. They will inject keratin into human scalps in order to grow thicker, stronger and denser hair.

Keratin Hair Growth Mice
Keratin injection induced hair growth in mice superior to topical Minoxidil. Source: Nature and KeraMedix.

KeraMedics Keratin Injections

Around 95% of our scalp hair is made up of keratin protein. This makes human hair so strong, that it can be indestructible for centuries. Human nails are also primarily made up of keratin.

A number of hair thickening shampoos and hair loss concealers contain keratin as a key ingredient. However, this type of usage is a very basic attempt. The approach by KeraMedix is much more scientific and well researched.

Earlier today, KeraMedix announced that it had applied to begin a Phase 1 clinical trial (IND) for its innovative new drug HK1. This drug is an injectable form of keratin.

This clinical trial will be conducted at the Department of Dermatology at Chung-Ang University Hospital (Seoul). It will enable the evaluation of the safety and tolerability of HK1 in 24 healthy Korean and Caucasian adults.

HK1 induces hair growth and suppresses additional hair loss by injecting thinning areas of the scalp with keratin.

In experiments, when human cells were treated with HK1, two things happened:

  • Aggregation of epidermal blast cells involved in hair growth.
  • Aggregation of dermal papilla cells.

Perhaps of most significance, the scientists involved in this work published a paper in Nature in November 2022. It was titled:

Keratin-mediated hair growth and its underlying biological mechanism.

In animal experiments using mice, a higher hair growth effect was seen in the group injected with keratin compared to the group treated with topical minoxidil (every day for 28 days). The before and after image of these mice can be seen at the top of this post. More images and information can be found on KeraMedix’s website.

Keramedix Keratin Hair Growth Injections.
Keramedix keratin hair growth injections. Source: Company website.

Keratin Microspheres

On a related note, in February 2024, a new Japanese paper was published in the journal ACS Applied Bio Materials. It is titled “Keratin Microspheres as Promising Tool for Targeting Follicular Growth.”

The researchers involved are from the University of Tsukuba (Japan). Check out their summary page on the effect of keratin microsphere gel on hair growth in mice.

In this study, the topical application of a water-soluble oxidized keratin gel (keratin microsphere gel) on mice:

“Significantly enhanced cell proliferation and the expression of genes associated with hair growth in the papilla cells of hair follicles, thereby stimulating hair development.”

The microspheres successfully penetrated the epidermis to reach the dermal papilla cells. Thereafter, they activated the key markers associated with hair growth.

Technoderma Phase 2 Clinical Trials Successful

February 6, 2024

Technoderma Phase 2 Trials Success

Technoderma’s Phase 2 clinical trials for TDM-105795 have succeeded. Per the official site announcement, they plan to move the clinical trials forward.

This Chinese company came out of the blue last year via its unique thyromimetic drug. Per the results of this Phase 2 trial:

  • The non-vellus Target Area Hair Count (TAHC) showed a mean increase from baseline of 24.3 hairs with the high-strength (0.02%) dosage topical solution. And an increase of 20.3 hairs with the low-strength (0.0025%) topical solution. This compared with a 14.0 hairs increase with placebo in a 1 cm2 test area.

According to the company’s chief medical officer, TDM-105795 has demonstrated hair growth in AGA with a favorable safety profile. They will therefore move forward with the clinical program.

TDM-105795 has poor systemic absorption after topical application and a short half-life. This makes the drug well-suited to avoid causing unwanted systemic effects.

Per CEO Zengquan Wang:

“We are committed to developing a portfolio of innovative dermatology drug candidates.”

April 12, 2023

TDM-105795 Phase 1 Trials

In February, someone e-mailed me a news link on Technoderma (China)’s site. At the bottom of that page devoted to dermatitis was a section on androgenetic alopecia (AGA):

“Previously, the company has completed the phase I clinical trial of TDM-105795 tincture in androgen alopecia (AGA), and is expected to initiate the phase II clinical trial in the middle of March 2023.”

On the company’s site, it says that TDM-105795 is a “first-in-class” small molecule thyromimetic drug candidate. It is being developed as a topical drug for treatment of androgenetic alopecia. Thyromimetics are synthetic analogs of thyroid hormones.

A 2022 study from China found that Technoderma’s thyroid hormone receptor agonist promotes hair growth in mice. They called the molecule thyroxine receptor agonist TDM 10842. The researchers suggest a potential mechanism to be the activation of Wnt/beta-catenin and Hedgehog pathways.

Note that the hair growth resulted via “the early induction of anagen” so it is not brand new hair. However, a prolonged anagen phase might make one’s remaining hair more resistant to the ravages of dihydrotestosterone (DHT). And perhaps help regenerate some recently miniaturized hair.

The Thyroid Hormone and Hair Growth

  • A 2024 US study found that topically applied T3 and T4 thyroid hormones stimulated hair growth in organ-cultured human scalp skin.
  • A 2016 study from Europe concluded that the thyroid hormone analogue KB2115 (Eprotirome) prolongs the human hair growth cycle (i.e., anagen).
  • A 2010 US study found that a thyroid hormone receptor beta subtype-selective thyromimetic 5 was efficacious in mouse and monkey hair growth after topical application.
  • A 2008 study even concluded that thyroid hormones (besides prolonging the anagen phase of the hair cycle) impact hair pigmentation.
Technoderma Hair Loss Pipeline.
Technoderma TDM-105795 for androgenetic alopecia.

Technoderma Begins Phase 2 Trials

Earlier today, someone e-mailed me that Technoderma just began recruiting for their Phase 2 clinical trials in the US per a Reddit post. They are moving just as fast as the other Chinese company Kintor Pharma.

The clinical trial page states a trial start date of April 17, 2023 and a completion date of November 30, 2023. Update: Now confirmed. First doses given.

They are looking for 72 volunteers. The sponsors and collaborators are listed as Technoderma Medicines Inc and Therapeutics Inc (a dermatology contract research organization).

The clinical trial page lists three research locations in Oregon, Texas and Virginia. However, per the Reddit post, there are thirteen cities across nine states where you can get recruited to participate. I will not post the city names or the contact person’s e-mail here for now, but you can check the Reddit.

I posted this right away because the 72 participant capacity will likely fill up very fast.