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and joined the MJH Life Sciences team in February 2023. She attended Kent State University and earned a Bachelor of Science degree in journalism with minors in public relations and creative writing. She enjoys making and listening to music, reading, and spending time with her cats, Astrid and Marceline.

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In case you missed it, this week we had news about APG777 EASI-75 response rates in atopic dermatitis, the unblinding of VYN202 after a safety pause, spesolimab and skin clarity between flares, and more.

The Weekly Roundup: July 7-11

Maddi Hebebrand is an associate editor of 

and joined the MJH Life Sciences team in May 2024. She attended Baldwin Wallace University, studying Media Production and Film, and received her Masters in Digital Media from Ohio University. When she's not writing, Maddi loves to read, attend concerts and spend time with her family. 

This week, we feature top articles from our sister publications on regulatory updates, clinical trial insights, and more.

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Catch up on dermatology news, highlights, and insights from the past 24 hours.

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Washington - Tighter restrictions on Accutane could have a reverse effect - increased black market activity - the FDA told a congressional investigative subcommittee on Dec. 11.

Accutane Illicitly Sold, Congress, FDA Warn

Columbus - When it comes to the regulation of office-based surgery, Brett Coldiron, M.D., has plenty to beef about in the Buckeye State. He even has a popular rally cry:

Lipo Rules Bad to the ...

Final Thoughts: The Importance of Comparative Studies in AD

Panelists offer concluding insights and emphasize the critical role of comparative studies in advancing atopic dermatitis treatment strategies.

clinical

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Hyperhidrosis is not rare. According to the 

, approximately 385 million people worldwide live with hyperhidrosis.

In fact, they note that the amount of people living with chronic, excessive sweating is even higher than the amount of people living with other dermatologic conditions like psoriasis.

Just how common is hyperhidrosis in real-world comparisons?

The prevalence of hyperhidrosis is much higher in younger populations than in the general population, with 8.8% of individuals between the ages of 18 to 39 years old living with the condition. 

When comparing these statistics to everyday, common occurrences like hair color, the number of people with hyperhidrosis is greater than the 1% of individuals with natural red hair and 2% of individuals with natural blond hair. 

Despite how common hyperhidrosis is, it is estimated that 27% of those with the condition never receive a diagnosis.

 wants to hear from you. What percentage of the global population is estimated to have hyperhidrosis?

 to share your hyperhidrosis insights or research.

Albert. Fact check: Hyperhidrosis - International Hyperhidrosis Society: Official site. Home - International Hyperhidrosis Society. October 24, 1970. Accessed November 16, 2023. 

https://www.sweathelp.org/home/news-blog/542-fact-check-hyperhidrosis.html

Hyperhidrosis affects approximately 385 million people globally, surpassing the prevalence of other dermatologic conditions like psoriasis. It is notably more common in younger populations, with 8.8% of individuals aged 18 to 39 experiencing the condition. Comparatively, hyperhidrosis is more prevalent than natural red or blond hair, which affects 1% and 2% of the population, respectively. Despite its prevalence, 27% of those with hyperhidrosis remain undiagnosed. The article encourages engagement during Hyperhidrosis Awareness Month to share insights and research on the condition.

Click here to answer this week's poll for Hyperhidrosis Awareness Month.

Polls 

POLL: What Percent of the Global Population is Estimated to Have Hyperhidrosis?

the US Food and Drug Administration (FDA) published over 200 decision letters

, known as Complete Response Letters (CRLs), in response to applications submitted for approval of drugs or biological products between 2020 and 2024. The agency says this marks a “significant step” in their broader initiatives to modernize and increase overall transparency.

“By making the CRLs available, the public now has significantly greater insight into the FDA’s decision-making and the most common deficiencies cited that sponsors must address before their application is approved,” the FDA said in a news release.

"In the world of drug development, transparency is critical for all parties involved - industry, clinicians, patients, and regulators. The recent publishing of complete response letters from the last 5 years is a bold and surprising move by the FDA, our main regulatory gatekeeper when it comes to the approval of new drugs," clinical associate professor at the Rosalind Franklin University Chicago Medical School, founder and director of the Center for Medical Dermatology and Immunology Research in Chicago, and a 

Editorial Advisory Board member, Raj Chovatiya, MD, PhD, MSCI, FAAD, told 

. One can surmise that the intention of this decision is to provide clarity surrounding drug application decisions that have been made by the FDA in recent years, and I am hopeful that in the long run, open communication of this kind of information will be used to strengthen the relationship between the FDA and drug developers, instill public trust in the regulatory process, and help demystify the world of pharmaceutical regulatory approval.

CRLs are issued when the FDA completes its review cycle and are sent directly to sponsors. They determine that an approval cannot be granted of an application in its current form. Recently in the world of dermatology, the FDA approved dupilumab for adolescents and adults with H1 Antihistamine-refractory chronic spontaneous urticaria (CSU), despite an October 2023 CRL stating that additional efficacy data were needed to support approval. In response to this CRL, Regeneron and Sanofi resubmitted the supplemental Biologics License Application (sBLA) including updated efficacy and safety data from a third phase 3 trial – 

ultimately leading to the long-awaited approval

The FDA can issue CRLs for various reason, most related to safety and efficacy concerns, manufacturing deficiencies, and bioequivalence issues. In the case of dupilumab for CSU, while additional efficacy data was requested the agency did not identify any concerns regarding safety or manufacturing. CRLs detail any deficiencies and may also include recommendations for addressing them.

In another case concerning prademagenezamikeracel (pz-cel) for the treatment of recessive dystrophic epidermolysis bullosa, 

the FDA issued a CRL noting the need for additional chemistry, manufacturing, and controls information

, including validation for specific manufacturing and release testing methods stated during the pre-license inspection. Abeona Therapeutics later resubmitted its BLAforpz-cel, 

leading to the April 2025 approval of the gene therapy

“For far too long, drug developers have been playing a guessing game when navigating the FDA,” said FDA Commissioner Marty Makary, MD, MPH, in the release. “Drug developers and capital markets alike want predictability. So today we’re 1 step closer to delivering it to them, with an ultimate goal of bringing cures and meaningful treatments to patients faster.”

The agency said that because the FDA has historically refrained from publishing CRLs for pending applications, it feels sponsors often misrepresent the rationale behind the FDA’s decision to their stakeholders and the public. According to a 2015 analysis conducted by FDA researchers, they stated sponsors avoided mentioning 85% of the FDA’s concerns about safety and efficacy when publicly announcing that their application was not approved. Moreover, the agency noted that when it calls for a new clinical trial for safety or efficacy, that critical information remains undisclosed around 40% of the time. Finally, the FDA stated that lessons learned from these non-approvals are not shared within the industry, ultimatly leading to companies repeatedly making similar mistakes.

The initial batch of published decision letters associated with since-approved applications is now accessible and open to the public at 

. In the release, the FDA noted that the CRLs were redacted for trade secrets and confidential commercial information. The agency stated it is in the process of publishing additional CRLs from its archives and is “continuously exploring ways of providing the public with greater transparency into its decision-making process.”

FDA embraces radical transparency by publishing complete response letters. News Release. US FDA. Published July 10, 2025. Accessed July 10, 2025. 

https://www.fda.gov/news-events/press-announcements/fda-embraces-radical-transparency-publishing-complete-response-letters?utm_medium=email&utm_source=govdelivery

Andrus E, Hebebrand M. FDA approves dupilumab for adolescents and adults with H1 antihistamine-refractory chronic spontaneous urticaria. News article. Dermatology Times. Published April 18, 2025. Accessed July 10, 2025. 

https://www.dermatologytimes.com/view/fda-approves-dupilumab-chronic-spontaneous-urticaria

Andrus E. FDA sets PDUFA date, accepts BLA submission for pz-cel in epidermolysis bullosa. News article. Dermatology Times. Published November 12, 2024. Accessed July 10, 2025. 

https://www.dermatologytimes.com/view/fda-sets-pfuda-date-accepts-bla-submission-for-pz-cel-in-epidermolysis-bullosa

Hebebrand M. FDA approves first gene therapy for RDEB. News article. Dermatology Times. Published April 29, 2025. Accessed July 10, 2025. 

https://www.dermatologytimes.com/view/fda-approves-first-gene-therapy-for-rdeb

The FDA has published over 200 Complete Response Letters (CRLs) from 2020 to 2024, enhancing transparency in its decision-making process. CRLs, issued when an application cannot be approved in its current form, provide insight into common deficiencies such as safety, efficacy, and manufacturing issues. The publication aims to reduce misrepresentation by sponsors and improve industry understanding of non-approvals. Notable cases include the approval of dupilumab for chronic spontaneous urticaria and prademagenezamikeracel for epidermolysis bullosa, following CRLs and subsequent resubmissions with additional data.

FDA enhances transparency by publishing over 200 Complete Response Letters, offering insights into drug approval processes and common deficiencies.

FDA Opens Access to Over 200 CRLs

Chronic hand eczema (CHE) represents a diagnostic and therapeutic challenge in dermatology. Characterized by persistent or relapsing inflammation of the hands lasting more than 3 months, or recurring at least twice within a 12-month period.

However, the term often serves as a clinical umbrella, and without thorough diagnostic workup, important distinctions can be overlooked. Proper evaluation is essential to determine whether a patient truly has CHE, or whether the presentation reflects a different condition such as allergic contact dermatitis (ACD), irritant contact dermatitis, or atopic dermatitis. These disorders may present with overlapping features, but they differ in pathogenesis, prognosis, and management.

Accurate diagnosis is essential, as misclassification may delay effective treatment or allow ongoing exposure to triggers. ACD, in particular, is frequently underrecognized.

Patch testing remains the gold standard for diagnosing ACD, allowing clinicians to identify hypersensitivity reactions to common allergens like nickel, fragrance mix, rubber accelerators, and preservatives. Importantly, ACD is not an eczema subtype, but a distinct immune-mediated condition that may share overlapping clinical and histologic features with other inflammatory dermatoses.

We want to hear from our readers: When assessing a patient with a dermatoses affecting the hands, how often do you perform patch testing to evaluate for CHE or other allergic, contact, and irritant conditions?

Ghezzi G, Falcidia C, Paolino G, et al. Chronic hand eczema (CHE): a narrative review. 

Tramontana M, Hansel K, Bianchi L, Sensini C, Malatesta N, Stingeni L. Advancing the understanding of allergic contact dermatitis: from pathophysiology to novel therapeutic approaches. 

. 2023;10:1184289. Published 2023 May 22. 

Patel K, Nixon R. Irritant contact dermatitis - a review. 

Kim J, Kim BE, Leung DYM. Pathophysiology of atopic dermatitis: Clinical implications. 

POLL: Do You Routinely Use Patch Testing When Evaluating Chronic Hand Eczema?

Jonathan Silverberg gave insights into what will be discussed at the upcoming meeting.

Road to RAD: The Ins and Outs of Managing CHE

, Jonathan Silverberg, MD, PhD, MPH, associate professor of dermatology at George Washington University School of Medicine and Health Sciences, emphasizes the importance of accurately identifying the underlying etiology of chronic hand eczema (CHE). He noted that hand eczema can arise from a range of dermatological conditions, including irritant contact dermatitis, allergic contact dermatitis, and atopic dermatitis. Proper diagnosis is essential for effective treatment planning, and diagnostic tools such as patch testing can be especially helpful in distinguishing among these different causes.

When it comes to treatment, Silverberg acknowledges that topical corticosteroids are commonly used due to their affordability and widespread availability, especially in terms of insurance coverage. However, he points out a significant gap in the availability of approved nonsteroidal topical therapies for CHE. Currently, any use of nonsteroidal treatments is considered off-label, meaning these medications are not officially approved for this specific condition.

Despite this, clinicians often turn to a variety of topical agents in their therapeutic toolbox. This may include topical calcineurin inhibitors, which have long been used off-label for eczema management. Additionally, some newer topical treatments that have recently received approval for atopic dermatitis may be considered as options for patients with CHE. Nevertheless, Silverberg underscores that robust clinical data supporting the efficacy of these newer agents specifically for hand eczema are still lacking.

Silverberg, a cochair of the Revolutionizing Atopic Dermatitis (RAD) Conference this week, will be presenting on a number of topics, including new and upcoming therapies, managing itch, and more. He will be joined by cochair Raj Chovatiya, MD, PhD, MSCI; 

 Editor in Chief Christopher Bunick, MD, PhD; Mona Shahriari, MD; and even more experts in the field. With presentations on everything from dose flexibility to late-breaking research, there is sure to be something for everyone at RAD 2025.

Want to hear more pearls and expert insights on AD? Join us at the annual 

Revolutionizing Atopic Dermatitis Conference

 this June in Nashville, Tennessee. Use code DT40 for 40% off your RAD 2025 registration.

For more expert insights on the topic, check out our 

 page. To stay up to date with the latest dermatology news, sign up to receive our 

Jonathan Silverberg, MD, PhD, MPH, highlights the critical need for accurate diagnosis of chronic hand eczema (CHE) to ensure effective treatment. CHE can result from various dermatological conditions, necessitating tools like patch testing for precise identification. While topical corticosteroids are commonly used due to their accessibility, there is a lack of approved non-steroidal therapies for CHE. Clinicians often resort to off-label use of topical agents, including calcineurin inhibitors. Silverberg will discuss new therapies and management strategies at the upcoming Revolutionizing Atopic Dermatitis (RAD) conference.

Jonathan Silverberg, MD, PhD, MPH, shares his insights on treating and managing CHE.

2025 Revolutionizing Atopic Dermatitis (RAD) Conference

 in Nashville, Tennessee, Eli Lilly and Company presented new data from the phase 3b ADmirable trial (

lebrikizumab’s effectiveness and safety

 in adult and adolescent patients with pigmented skin and atopic dermatitis, as this population is typically underrepresented in clinical trials.

, Anabela Cardoso, MD, senior vice president of immunology medical affairs at Eli Lilly, discussed clinical decision-making around lebrikizumab’s mechanism and dosing flexibility, patient-centered considerations such as safety, convenience, and injection experience, the value of data sharing at focused meetings such RAD, and Lilly’s ongoing dermatology pipeline.

, Cardoso provided an overview of the ADmirable trial, key data points she would point out to clinicians, and the significance of the study focusing on patients with skin of color with moderate to severe atopic dermatitis.

Q: Regarding the high percentage of patients who achieved improvements in itch, pigmentation, and quality of life, how do you see lebrikizumab fitting into a clinician's treatment options?

: That’s a very important part, because when a clinician thinks about the [patient with] moderate to severe [disease], it means it's a patient who already had topical steroids or other topical therapies, and it's considered now still active and needs to move to another option.

There are several options, of course, and that's important—that there are different options for patients. For lebrikizumab, not just with this data, but the totality of the data, the fact that it targets IL-13, a very central cytokine of the disease, and proven not just mechanistically but in the clinical trials to impact the skin severity and also itch, it's a major component of a choice.

I think when a physician sees a patient, they need to think about that: “What do I want to treat and target?” And so, acting on these 2 components of the disease is important.

The bulk of data that we now have with lebrikizumab supports using it as monotherapy, which is very convenient for patients if they don't need to have the burden of the steroids. It supports the use in these different ranges of patients, which range from naïve to biologics, different skin tones, and patients who were already exposed to biologics.

Physicians can be reassured that for the patient in front of them, there’s a piece of data from the lebrikizumab clinical program that represents that patient.

The other most important choice when it comes to treating patients is the fact that after the first 16 weeks with every 2-week administration, a vast majority of patients can move into monthly dosing, which happened in this trial as well. When they move to monthly dosing, the vast majority maintain or continue to have improvement.

There's the convenience of the administration, and the convenience of going monthly to maintain the efficacy, and then that efficacy has been proven already in the 3-year data.

These data build on the fact that lebrikizumab can be an important option for patients who want to go into maintenance once a month after being cleared, and for a diverse type of population, including patients with different skin tones. I think that’s good news for physicians and patients—that this is another option for first-line therapy.

Q: You mentioned that 73% of patients were able to move to once-a-month dosing by week 16. How does that data point help clinicians understand maintenance schedules?

: I personally think that for patients, a lot of things matter. And for physicians, of course, the efficacy matters, the safety matters, but it also comes down to how the medicines adapt to patients who are active.

Atopic dermatitis affects women, men, students, people who need to go to school, people who need to go to work, or have kids to take care of—and there's already a burden of applying creams.

I believe that even if all things were equal, it’s important to discuss with the patients what they can expect from a certain medicine, and tell patients they can expect a more intensive regimen in the first 4 months, but then it can go to once a month. Think about it once a month, and hopefully they don’t think about it more during that period.

The safety profile has been very well characterized, so there are no boxed warnings or other big concerns. Also consider that it has already shown 3 years of data.

I think those are elements that matter for someone to start to predict, “What’s going to be my life once I’m on a biologic?”

The other factor is the device and the experience and the injection site pain, or existence of those. Lebrikizumab has shown very nice data in terms of providing a good experience and low injection site reactions. And I think those things matter, if I put myself in the shoes of a patient.

At Lilly, we try to, more now than in the past, to focus not just on the medicine, but also on the experience of the patient.

Q: In your opinion, what is the value of a disease-specific meeting such as RAD?

: I have attended RAD since the first time it was organized. I remember when it was established, the organizers wondered, “How many people will come? How successful will this be?”—because they decided to focus on a disease that, at that time, was not as widely spoken about as, for example, psoriasis.

I value this type of meeting because it has the top experts, and you also get an audience that is really interested in the disease. They go to the meeting because they treat atopic dermatitis patients. They want to know more. They get engaged in the novelties. And they want to establish this network of experts that can talk to each other and learn from that.

We at Lilly see it as a great place to bring novel data like this, because most of the audience will attend all the sessions and will learn from the sessions, because they are interested in the topic.

Anabela Cardoso, MD, reflects on specific data from the phase 3b ADmirable trial evaluating the safety and efficacy of lebrikizumab in patients with moderate to severe AD and pigmented skin. 

Thomas P. Skernivitz

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