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

In April, Cosmo Pharmaceuticals released 

 on clascoterone 5% topical solution in male patients living with mild-to-moderate androgenetic alopecia (AGA), with sustained efficacy being observed with continued use in the program.

The study, involving 1465 patients across 51 sites in the US and Europe, was the largest phase 3 clinical analysis effort to date for a topical drug in male patients with AGA. In light of the lack of newly-approved drugs for AGA in more than 3 decades, 

 spoke in an interview with Maria Hordinsky, MD, an R.W. Goltz Professor of Dermatology at the University of Minnesota and a lead investigator in the trial program, who spoke about the clinical and patient-centered implications of these data.

The following Q&A transcript summarizes Hordinsky’s responses to 

’s inquiries about the new data on clascoterone 5% topical solution for patients with hair loss in the form of AGA:

What were the most important takeaways from this phase 3 study of clascoterone 5% topical solution for patients with androgenetic alopecia (AGA)?

 I'll think about this from the perspective of a patient in the clinic, and think about what patients are looking for. There hasn't been a new FDA treatment, a medical treatment, for over 30 years. It's been a long time since something has come to this point with the current medication. So, we now have the opportunity to really use a topical agent that targets the androgen receptor, one of the key players in androgenetic alopecia. Patients in this particular study, phase 2 and phase 3, have done very, very well. It looks like we're going to very soon have a new tool in our toolbox that will be able to offer male patients with androgenetic alopecia. It's actually very exciting.

We also wanted to go explore some of the findings. The data show continued hair growth from Month 6 to Month 12. How clinically meaningful is that sustained response for patients?

That is very clinically relevant. What I would love to see…but again, the FDA did not require this. I think it'd be great, and we'll get it in real-world data, [but I’d love us] to be able to see the durability over years of use. But the fact that the durability was there at the 12-month mark and also was showing, at that time, continued improvement is, again, something very exciting.

Can you explain the significance of the 239% relative improvement in target area hair count and how that translates into real-world outcomes?

 Patients with pattern hair loss, if you talk to them about hair counts in a circle, it probably doesn't mean very much to people. You might have X number of fibers, and then you double it or triple it, and then you'll see something there. But from the patient's perspective, they're looking at the global picture, the big picture. So, the patient's perspective is really, really important. Then, when you go to that target area, you see this increase in hair counts to this particular significant number. That is really important, because that is visible and it's real.

What does the comparison between patients who stayed on treatment versus those who switched to vehicle tell us about the importance of continuous therapy?

 I think all these studies were done very well. I think it's always important to have a group of people who are treated, and then at some point in time, in a randomized manner, are switched to the placebo group, because you can see the improvement, and then you can see the decline. I think, like with most hair conditions when we treat [them], the decline is not like jumping off a cliff. It's gradual. So, in all likelihood, down the road and in the future, one will actually be able to capture that, because people sometimes get sick. You know, things happen in life. You're going to come off the medication for a bit of period of time, and I think people just have to recognize from this data that, yes, you might go backwards a little bit, but you can probably catch up.

Based on these findings, how do you see clascoterone solution fitting into the current treatment landscape for hair loss?

Well, I think hair is hot right now in so many ways. There are so many things that are being looked at from so many different perspectives for the treatment of pattern, hair loss, this particular product, product, and tool is here at the right time, because many of the other tools are still very early in development. From a patient's perspective, there are those who just want to do something topically. They don't want to take a pill. They want something very conservative. And then some want to do everything possible and add PRP and everything to the mix of what they're doing. It will be a great tool to use for people who have pattern hair loss, who are either very conservative or want to do everything that they can.

But the other place where this really fits is that the vehicle and the delivery system are very, very nice. It's easy to use and it's something that, if you think about your 18-year-old male who's going to college, sometimes that type of person wants to take a pill by mouth, but at other times, the person, again, just wants something straightforward and simple. This is going to be something that will fit the lifestyle of that particular person. It will also be a tool for many patients who really do not want to be taking any type of anti-androgen or medication currently on the market that can affect libido or sex drive, because right now, we know with this medicine, even though it is an androgen blocking agent, a receptor blocking agent, no such side effects were detected in the clinical trials. I think that's really important.

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

Hordinsky has served on an advisory board for AbbVie (fees) and as an investigator receiving grants or research funding from Arcutis Biotherapeutics, Cassiopea, Concert Pharmaceuticals, Eli Lilly and Company, National Alopecia Areata Foundation, RegenLab, and Sun Pharmaceuticals. She has also received fees for other work with UpToDate, Inc.

Phase III 12-Month Data for Clascoterone 5% Topical Solution Confirm Positive Safety for Chronic Use and Continued Hair Growth, both of which Are Statistically Significant. Cosmo Pharmaceuticals. April 15, 2026. Accessed April 30, 2026. 

https://www.cosmohealthconfidence.com/news/98958067-clascoterone-12-month-safety-results-ende

Hordinsky M. Phase 3 SCALP Study on Clascoterone for Androgenetic Alopecia, With Maria Hordinsky, MD. HCPLive. December 18, 2025. Accessed April 30, 2026. 

https://www.hcplive.com/view/phase-3-scalp-study-clascoterone-androgenetic-alopecia-maria-hordinsky-md

Articles

Phase 3 SCALP program evaluated clascoterone 5% topical solution, an androgen-receptor antagonist, in 1465 men with mild-to-moderate androgenetic alopecia across 51 US/European sites. Twelve-month data showed statistically significant, sustained and incremental gains from Month 6 to 12, supporting chronic use. A 239% relative improvement in target-area hair count suggests visible density changes, while patient-perceived global improvement remains central. Randomized withdrawal to vehicle indicated gradual regression off therapy, implying maintenance dosing and potential regain after interruptions. Favorable tolerability without libido/sexual adverse signals may broaden uptake.

In this Q&A interview, Hordinsky was asked about recent 1-year data on clascoterone solution 5% in androgenetic alopecia (AGA).

Q&A: 1-Year Efficacy Data on Clascoterone 5% in Androgenetic Alopecia, With Maria Hordinsky, MD

Sustained 1-Year Efficacy Seen with Clascoterone for Androgenetic Alopecia, With Maria Hordinsky, MD

Cosmo Pharmaceuticals announced positive 12-month phase 3 findings on clascoterone 5% topical solution in men with 

mild-to-moderate androgenetic alopecia (AGA)

, noting the treatment’s sustained efficacy with continued use.

These data highlighting the success of the drug in recent phase 3 clinical trials were discussed by trial investigator Maria Hordinsky, MD, an R.W. Goltz professor of dermatology at the University of Minnesota, who emphasized the significance of the results from both clinical and patient perspectives. The trial program was described as the largest phase 3 program ever done for a topical treatment of androgenetic alopecia in males, with 1465 patients recruited across 51 sites in US and Europe.

“There hasn't been a new FDA…medical treatment, for over 30 years,” Hordinsky noted. “It's been a long time since something has come to this point with with the current medication. We now have the opportunity to really use a topical agent that targets the androgen receptor, one of the key players in androgenetic alopecia.”

In Hordinsky’s view, this positions clascoterone as a potentially important addition to the treatment armamentarium. As a topical androgen receptor inhibitor, the therapy directly targets a key driver of AGA, providing a novel mechanism of action compared to existing choices among patients suffering from such hair loss conditions. She highlighted the clinical relevance of the sustained efficacy observed between Months 6 - 12, describing the continued improvement over time as exciting.

Although she expressed interest in seeing longer-term durability data in real-world settings, Hordinsky underscored these 12-month findings, already, show meaningful persistence of benefit for those with AGA. With regard to the reported 239% relative improvement in target area hair count (TAHC), she stressed while numerical metrics are important, perception among patients also remains central. Hair counts rising can translate into visible, tangible shifts for those with hair loss, aligning clinical outcomes with real-world expectations of improved hair appearance and density.

The trial design, which involved a comparison between subjects on clascoterone and those shifted to vehicle following 6 months, additionally reinforced the value of ongoing use. Those who discontinued active treatment reported a gradual loss of benefit, suggesting consistent use may be necessary to maintain the positive results. Looking ahead, Hordinsky noted clascoterone would likely fit well into a growing and increasingly personalized AGA treatment landscape.

For more information on these data, view the full video interview posted above.

Phase III 12-Month Data for Clascoterone 5% Topical Solution Confirm Positive Safety for Chronic Use and Continued Hair Growth, both of which Are Statistically Significant. Cosmo Pharmaceuticals. April 15, 2026. Accessed April 20, 2026. 

Hordinsky M. Phase 3 SCALP Study on Clascoterone for Androgenetic Alopecia, With Maria Hordinsky, MD. HCPLive. December 18, 2025. Accessed April 20, 2026. 

Videos

This interview highlights positive 12-month phase 3 results on clascoterone 5% topical solution for mild-to-moderate androgenetic alopecia, or hair loss.

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. 

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.

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