Maria Hordinsky, MD, is an R.W. Goltz Professor of the Department of Dermatology at the University of Minnesota.

Maria Hordinsky, MD

Credit: National Alopecia Areata Foundation

New topline, phase 3 findings from the SCALP 1 and 2 studies have been released by Cosmo Pharmaceuticals suggesting clascoterone may be an effective medication for men living with 

Androgenetic alopecia, commonly referred to as male pattern hair loss, would have the first new therapeutic agent in over 3 decades if clascoterone were to receive approval by the 

 Clascoterone solution was formulated to target androgenetic alopecia via a novel biological pathway, selectively binding to androgen receptors in the skin and scalp.

Both SCALP 1 and SCALP 2 attained statistically significant endpoints in Target-Area Hair Count (TAHC) results.

 To discuss these new findings on clascoterone and androgenetic alopecia, the 

 editorial team spoke with Maria Hordinsky, MD, an RW Goltz Professor of Dermatology at the University of Minnesota, along with Diana Harbort of Cosmo Pharmaceuticals. Hordinsky and Harbort highlighted a variety of key points from the data:

Would you speak with us about the trial design itself and what these studies assessing clascoterone looked like?

 We here at the University of Minnesota were engaged in this particular clinical trial, and it was a trial where patients were applying the topical medication twice a day. The data that is out there is from the first 6 months. There is still another 6 months of data that is under review at present. We were blinded, like all the sites, as to whether or not a participant was receiving the actual drug or not. This is where I'm going to turn to Diana, because Diana can talk about the 2 studies [in depth]. There are 2 different studies examining the same clinical trial goals. Can you comment on that?

The phase 3 program for clascoterone solution contained 2 identical in design trials. These were multi-center, prospective, randomized, 2-to-1 vehicle-controlled studies with either the vehicle or the study drug being delivered BID. The study enrolled 1465 patients with mild to moderate AGA in 51 sites across the US and Europe. Scalp 1 is the pivotal part of the program, which is meant for just the first 6 months of treatment, and the goal is to evaluate the safety and efficacy of the drug versus the vehicle.

Scalp 2 is identical in design to the first 6 months to also evaluate the safety and efficacy. So part 1 is the pivotal part, and part 2 is the safety extension part, where patients roll over from scalp one or scalp to the responders' rollover into the second 6 months of the trial. The goal of that is to determine the long-term safety and durability of the treatment. In part one, the co-primary efficacy endpoints are the TAHC and the patient-reported outcomes.

Would either of you explain some of the most notable findings for the 6 months of treatment with clascoterone and androgenetic alopecia?

From an investigator's point of view, the findings are outstanding in that sense that the total number of hair counts in the areas that were mentioned increased greatly. I can tell, just in our own institution, and the patients who participated with us, again, didn't know what they were on, and neither did we. When you see improvement, you assume that the patient has been on the actual medication. Patients found the medication to be tolerable.

If you look at the safety data across the entire studies, both studies to date, the safety profile is very good, with minimal irritation to the skin from the use of the topical product and, most importantly, very few systemic or internal side effects. We're dealing here with a topical agent that targets testosterone and the receptor, so when you start to think about medications that might impact hormones, we're talking about something that really impacts hormones in the skin alone. Another very important point from this particular study is that there were very there were no significant sexual side effects related to the use of this topical medication twice a day.

In light of what you have said, what are some of the most notable concerns patients might have regarding some unmet needs related to existing treatments?

 I can speak from personal experience in the clinic. When a person comes in who's in their early twenties and is starting to develop early pattern alopecia, or androgenic alopecia, also known as male pattern baldness, then one has to think, ‘What can we do at that particular stage?’ At this time, we have 2 approved medications. We have topical minoxidil, or Rogaine in a liquid or foam preparation, and we have an oral medication called finasteride, which blocks the conversion of testosterone to dihydrotestosterone.

I just gave the example of someone in their early 20s taking a pill that, more recently, has risen to the top of social media in terms of having significant side effects. With topical minoxidil, it does work, but as has been pointed out, this medication was approved almost 30 years ago, so we have basically 2 medications that we can really talk about that are FDA-approved to that young person sitting there talking about how to prevent hair loss.

Our other options when we're in clinic we’ll be to talk about are devices like red light therapy, which you have to do a few times per week, or something like platelet-rich plasma. We don't talk about hair transplantation in those early stages, but we do talk about how, if you don't do anything, we really don't know how far this hair loss is going to extend…So that young patient in the clinic is getting a lot of information about a lot of different approaches to treating male pattern hair loss or androgenetic alopecia. That's why this new topical is so exciting, because it's a completely different mechanism of action. It's topical, and the 6-month data looks really, really good.

Cosmo announces breakthrough Phase III Topline results from Scalp 1 and Scalp 2 for Clascoterone 5% Solution in male hair loss, showing up to 539% relative improvement in Target-Area Hair Count vs placebo; US and EU submissions are underway. Cosmo Pharmaceuticals. December 3, 2025. Accessed: December 18, 2025. 

https://www.cosmopharma.com/news/cosmo-announces-breakthrough-phase-iii-topline-results-from-scalp-1-and-scalp-2-for-clascoterone-5-solution-in-male-hair-loss-showing-up-to-539-relative-improvement-in-target-area-hair-count-vs-place

Chen S, Li L, Zhou N, et al. Androgenetic alopecia: An update on pathogenesis and pharmacological treatment. Drug Des Devel Ther. 2025 Aug 25;19:7349-7363. 

Articles

Clascoterone, a novel topical solution, shows promise as a treatment for androgenetic alopecia, marking the first potential new therapy in over 30 years. Phase 3 trials, SCALP 1 and 2, demonstrated significant improvements in Target-Area Hair Count (TAHC) with minimal side effects. The trials involved 1465 patients across the US and Europe, focusing on safety and efficacy. Current treatments include minoxidil and finasteride, but clascoterone offers a new mechanism of action, targeting androgen receptors in the skin, with promising 6-month data.

Cosmo Pharmaceuticals released pivotal phase 3 findings on clascoterone treatment, a potential first-in-class medication designed to target androgenetic alopecia.

Phase 3 SCALP Study on Clascoterone for Androgenetic Alopecia, With Maria Hordinsky, MD

Trichoscopy’s Role in Differentiating Alopecia Types, with Maria Hordinsky, MD

A session titled ‘Spotting Scarring Alopecia Early: Clues, Challenges, and Clinical Pearls’ was presented during the 

2025 SDPA Annual Summer Dermatology Conference

The presenter, Maria Hordinsky, MD, was interviewed by 

’s editorial team on the major highlights described in her talk. Hordinsky is an R.W. Goltz Professor at the University of Minnesota Department of Dermatology. Hordinsky was asked in this segment of her interview about how dermoscopy—or more specifically, trichoscopy—helps differentiate early-stage scarring alopecias from mimickers like telogen effluvium or traction 

“The trichoscopy of the scalp is amazing,” Hordinsky said. “With that instrument called the dermatoscope, one can take a look at the skin of the scalp and see if there's inflammation present, whether it's diffuse and loose like you would see in dandruff. Is it kind of a loose scale, or is there hugging of the scale? Is the scale hugging the hair fiber as it exits out of the skin, which goes along more with the scarring alopecia? With trichoscopy, you can also see if scarring has already occurred.”

Hordinsky noted that particularly in more richly-pigmented skin types, the network of the skin can face injury and scarring due to such alopecia. Occurred. In terms of density, with dermoscopy or trichoscopy, Hordinsky noted that one can also note the quality of the hair fibers.

“So, a good picture of the scalp would show you that most of the hair fibers are very uniform,” Hordinsky explained. “They're of the same diameter. But if there's pattern hair loss occurring, or abnormal hairs are coming back, there's going to be a lot of variation in fiber diameter and also perhaps in the quality of the hair.”

Hordinsky was asked about any other clinical pearls worth mentioning that were featured in her presentation on scarring alopecias.

“I think it's really important to recognize that when you're working with a patient as a scarring alopecia, and you are doing all the right things that are in the algorithm for the treatment of a scarring alopecia, if your patient does not get better, then you have to think about allergic contact dermatitis,” Hordinsky said. “Because sometimes the treatments that we prescribe, or the injections that we do, have chemicals in them that your patient might be allergic to. It's very important to recognize if you're doing everything you can and the patient's not getting better. Then it's time to investigate with testing, to figure out if there's something the patient's coming in contact with that's driving this process.”

For any further information on scarring alopecia covered in Hordinsky’s presentation at SDPA 2025, view her full interview segment posted above. To find out more about alopecia and other dermatologic diseases highlighted at the meeting, view the 

The quotes used in this interview summary were edited for the purposes of clarity.

Videos

Maria Hordinsky, MD, spoke at SDPA regarding her talk highlighting a variety of clinical pearls for spotting scarring alopecia early.

Clinical Pearls for Spotting Alopecia Scarring Early, with Maria Hordinsky, MD

 editorial team interviewed Maria Hordinsky, MD, regarding the biggest takeaways from her conference talk titled ‘Spotting Scarring Alopecia Early: Clues, Challenges, and Clinical Pearls.’

Hordinsky, an R.W. Goltz Professor at the University of Minnesota Department of Dermatology, discussed some of the points of her session on spotting alopecia scarring early, highlighting different aspects for clinicians to keep in mind. First, given that scarring alopecia is notoriously difficult to catch early, Hordinsky was asked what the earliest clinical or patient-reported signs that raise red flags for clinicians would be.

“Some of the early signs might be symptoms like pain, burning, or itch in a certain part of the scalp,” Hordinsky explained. “And then clinically, when one looks at the scalp, one may see inflammation around the hair follicles and perhaps only redness in the general area of involvement, as well as scalp hair loss. Catching things early, before they spread, is really important.”

 team also asked Hordinsky about how subtle symptoms can be differentiated from more common non-scarring conditions.

“That is a great question, because many people have what's called seborrheic dermatitis, or dandruff, so to speak,” Hordinsky said. “So they could have dandruff or seborrheic dermatitis all over their scalp just as an underlying baseline. Then when they get a scarring alopecia, there is even more inflammation in a certain area of the scalp where that inflammatory scarring alopecia is occurring. So basically, you have to treat the whole scalp when you approach patients with these conditions.”

Hordinsky was also asked what clinicians now understand about the earliest stages of follicular destruction in scarring alopecias and about ways this may inform earlier intervention.

“We've known for decades that the inflammation in scarring alopecia is in the stem cell region, or the bulge region of the hair follicle,” Hordinsky explained. “So that's in the upper third of the hair follicles. We've all known that for a long time, and now people are understanding what those cells are that are coming in there. We've known also for years that these are primarily cells called lymphocytes. But now people are starting to understand what kind of lymphocytes these are…So the science is moving forward to understand better what these cells are and how to better target them, and what these cells release, so that this also could be targeted in treatments.”

In her SDPA interview,  Maria Hordinsky, MD, spoke about her session regarding clinical pearls for clinicians seeking to spot alopecia early in patients.