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Marie Bosslett is the assistant editor of 

 and joined the MJH Life Sciences team in October 2024. She attended Loyola University Maryland in Baltimore and earned a Bachelor of Arts in Communication with minors in marketing and writing. When she’s not writing, Marie enjoys going to concerts, reading on the beach, and spending time with friends and family.

Articles

The Broader Spectrum of Sun Damage and Skin Protection

A new comparative study evaluated positive outcomes from patient use of a gua sha versus a facial roller over 8 weeks of treatment.

At-Home Facial Massage Methods Clinically Proven to Improve Skin Elasticity, Tone, and Contour 

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.

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

Daily Derm Times: June 12, 2025

Maureen Offiah, MD, is a board-certified dermatologist at Hattiesburg Clinic in Mississippi.

Maureen Offiah, MD, reflected on the key takeaways as an attendee at the 2025 Revolutionizing Atopic Dermatitis (RAD) Conference in Nashville, Tennessee.

A Clinician’s Perspective of RAD 2025: Part 1

Dermatology Times connects dermatology professionals with key skin disorder coverage, therapeutic strategies, clinical trial updates, and expert insights.

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In this follow up to last month’s Innovations column on intellectual property and technology transfer, Raymond A. Miller, J.D., and Steve Xu, M.D., FAAD discuss how to utilize patents to maximize value for your venture.

How to use patents to maximize value for your venture

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

Video Series

 has submitted a clinical trial application to Germany's Paul-Ehrlich-Institut, the country's federal institute for vaccines and biomedicines, to initiate a phase 1/1b trial of ALY-301 for cold urticaria.

The study will assess the efficacy and safety of the mast cell selective c-Kit inhibitor in the subtype of chronic inducible urticaria. 

The submission marks the first clinical trial stemming from Alys’ proprietary Granular platform, an antibody engineering framework designed to target mast cell biology with precision. ALY-301 represents a first-in-class bispecific antibody engineered to selectively inhibit c-Kit, a receptor critical for mast cell survival,

 while sparing other c-Kit–expressing cells.

Cold urticaria can have a significant impact on patients' quality of life and often lacks satisfactory treatment options.

 Although c-Kit inhibition has long been recognized for its therapeutic potential in mast cell diseases, most prior attempts have been limited by safety concerns.

According to Alys Pharmaceuticals, the distinct selectivity of ALY-301 is expected to enable safe, long-term administration, potentially opening the door to treatment of a wider spectrum of mast cell–associated disorders beyond cold urticaria, such as chronic spontaneous urticaria, atopic dermatitis, and systemic mastocytosis.

The upcoming phase 1/1b trial will be conducted across multiple sites in Germany. In addition to evaluating the safety and tolerability of ALY-301 in healthy volunteers, the study will assess pharmacokinetics, pharmacodynamics, and early signs of clinical activity in patients with cold urticaria.

"ALY-301 offers a truly differentiated approach. It is the only c-Kit antibody designed to target activated mast cells while avoiding off-target effects," Brian S. Kim, MD, said in a news release.

Kim is the Sol and Clara Kest Professor and vice chair of research at the Icahn School of Medicine at Mount Sinai in New York, New York.

Kim, who is also chair of Alys’ scientific advisory board, emphasized that ALY-301 uniquely targets activated mast cells while sparing other cell populations that have historically contributed to adverse effects with nonselective c-Kit inhibitors.

Martin Metz, MD, a global authority on urticaria and principal investigator for the ALY-301 trial, echoed this sentiment: "The concept behind ALY-301, to enable safe and effective chronic dosing of a c-Kit agent through mast-cell selectivity, has been strongly supported across all nonclinical studies."

Metz, who holds appointments at the Charité – Universitätsmedizin Berlin and the Fraunhofer Institute in Germany, added, "It is very exciting to start the clinical journey today, especially since this first clinical trial will yield clinical outcomes from urticaria patients. The ability to deliver safe and effective chronic c-Kit inhibition through selective mast cell targeting is an exciting breakthrough.

Thibaud Portal, cofounder and chief operating officer of Alys Pharmaceuticals, highlighted the broader significance of ALY-301 within the evolving therapeutic landscape for allergic diseases. 

"Recently, there has been intense attention to solving Urticaria and other allergic diseases, with keen interest in c-Kit targeting. Data have demonstrated the remarkable potency of the mode of action, but indiscriminate c-Kit targeting has been coupled with chronic safety challenges," Portal said.

 "With its expected safety margin and broad applicability across multiple diseases, this marks another pivotal moment for Alys in our journey to bring innovative treatments to patients."

Alys Pharmaceuticals announces CTA submission for ALY-301, the first mast cell selective c-Kit inhibitor for treatment of cold urticaria. News release. Alys Pharmaceuticals. June 10, 2025. Accessed June 11, 2025. 

https://www.prnewswire.com/news-releases/alys-pharmaceuticals-announces-cta-submission-for-aly-301-the-first-mast-cell-selective-c-kit-inhibitor-for-treatment-of-cold-urticaria-302476572.html

Tsai M, Valent P, Galli SJ. KIT as a master regulator of the mast cell lineage. 

Hochstadter EF, Ben-Shoshan M. Cold-induced urticaria: challenges in diagnosis and management. 

. 2013;2013:bcr2013010441. Published 2013 Jul 8. 

El-Agamy DS. Targeting c-kit in the therapy of mast cell disorders: current update. 

Barzolvolimab (CDX-0159) has shown promising results in reducing symptoms in patients with moderate to severe antihistamine-refractory chronic spontaneous urticaria (CSU). In a phase 1b study, barzolvolimab demonstrated significant suppression of serum tryptase and substantial reductions in disease severity, with many patients achieving near-complete symptom control. The treatment was well-tolerated, with mostly mild to moderate adverse events. Despite the study's small sample size, these findings suggest barzolvolimab as a potential novel treatment for severe CSU, warranting further investigation in larger-scale studies.

Alys plans to conduct a phase 1/1b trial assessing the efficacy and safety of the mast cell selective c-Kit inhibitor in the CIndU subtype.

Alys Pharmaceuticals Submits ALY-301 Clinical Trial Application in Germany for Cold Urticaria

Among the late-breaking data shared at the 

2025 Revolutionizing Atopic Dermatitis (RAD)

 conference in Nashville, Tennessee, Sanofi and Regeneron presented positive results from the DISCOVER trial, a phase 4 study of patients with skin of color being treated with dupilumab (Dupixent) for moderate to severe atopic dermatitis (AD).

In earlier phase 3 studies of dupilumab, subgroup analyses demonstrated a risk-benefit profile in patients with skin of color compared with the overall population.

 However, the sample size was limited. This vulnerable patient population is severely underrepresented in clinical research, despite the high disease prevalence, severity, and quality-of-life burden. The goal of the open-label, single-arm DISCOVER study (NCT05590585) was to further evaluate the efficacy and safety of dupilumab when used as a monotherapy in this patient group

Eligible participants in the analysis (n = 120) were 12 years or older with Fitzpatrick skin types IV (43%), V (48%), and VI (9%). The mean age was 37.6 years, and 46.7% were female; 81% self-identified as Black/African American.

At baseline, the average Eczema Area and Severity Index (EASI) score was 16 or higher, and the average Investigator’s Global Assessment (IGA) score was 3 or higher, with 31.7% having a score of 4. The mean body surface area (BSA) involved was approximately 10% or greater, and the weekly average of Peak Pruritus Numeric Rating Scale (PP-NRS) was 4 or higher. The average disease duration was 19.8 years.

Patients were treated with only dupilumab every 2 weeks. Those who weighed less than 60 kg received 200 mg, with a 400-mg loading dose on day 1. Those who weighed more than 60 kg received 300 mg, with a 600-mg loading dose on day 1.

The primary end point was a 75% or greater improvement from baseline in EASI (EASI-75). Investigators also evaluated PP-NRS, IGA, BSA, and any treatment-emergent adverse effects. The Post-Inflammatory Hyperpigmentation Severity Scale (PHSS) assessed overall disease severity, pigmentary intensity and area of lesions, degree of hypopigmentation, and other symptoms including erythema, burning, peeling, and dryness. Additionally, the Xerosis in Atopic Dermatitis tool was used, which is a newly developed instrument to help assess patient-reported outcomes on the feeling and appearance of dryness of the skin.


After 24 weeks of dupilumab monotherapy, 76% of patients achieved an EASI-75 response. Positive changes in PP-NRS were also observed, with 65.6% achieving a 3-point or higher improvement, and 52.7% achieving a 4-point or higher improvement.

According to the PHSS markers, a 52.9% decrease in physician-assessed disease severity of postinflammatory hyperpigmentation was noted, with a moderate to marked score at baseline (5.1) to a mild score at week 24 (2.4). Nearly 80% of participants began the trial with moderate to severe hyperpigmented lesions. This decreased to 35%, with 65% of patients expressing that the intensity of their lesions had minimized to none, trace, or mild.

Xerosis NRS dropped from 8.2 at baseline to 4.8 at the conclusion of the trial. More than 80% of patients reported that they were either not bothered at all or only somewhat bothered by how dry their skin looked and felt. By comparison, when the study began, nearly 50% were extremely bothered by their dryness.

Regarding safety, 41.9% of patients experienced at least 1 treatment-emergent adverse event (AE). The most frequently reported AEs included headache, eczema, upper respiratory tract infection, and conjunctivitis. Only 3 AEs led to the discontinuation of dupilumab, and none of the treatment-emergent adverse events were serious.

Overall, the DISCOVER trial showed that dupilumab monotherapy improved signs and symptoms of moderate to severe AD in patients with skin of color. This included AD-related postinflammatory hyperpigmentation and patient-reported xerosis. These data give clinicians full awareness of dupilumab’s success rates, even in this patient population that is typically underrepresented in clinical research.

1. Alexis A, Markowitz O, Mayo T, et al. Dupilumab monotherapy in patients with skin of color and moderate-to-severe atopic dermatitis: results from a phase 4, open-label study. Presented at: 2025 Revolutionizing Atopic Dermatitis Conference; June 6-7, 2025; Nashville, TN.

2. Alexis AF, Rendon M, Silverberg JI, et al. Efficacy of dupilumab in different racial subgroups of adults with moderate-to-severe atopic dermatitis in three randomized, placebo-controlled phase 3 trials. 

At RAD 2025, the DISCOVER trial showed that dupilumab monotherapy significantly improved moderate to severe AD symptoms in this patient population.

Late-Breaking Data: Positive Outcomes in Patients With Skin of Color With AD Using Dupilumab  

Aaron Farberg, MD, a double board-certified dermatologist and chief medical officer at Bare Dermatology in Dallas, Texas, led a panel of colleagues in conversation for a 

Dermatology Times Clinical Case Collective 

Navigating the Complexities of Generalized Pustular Psoriasis Diagnosis and Management

. For this discussion grounded in real-world patient cases, Farberg was joined by Tina Bhutani, MD, MAS, board-certified dermatologist at Synergy Dermatology in San Francisco, California; Christopher Bunick, MD, PhD, associate professor of dermatology at Yale University in New Haven, Connecticut, and 

’ editor in chief; and Harrison Nguyen, MD, MBA, MPH, double board-certified dermatologist and clinical researcher at Harrison Dermatology in Houston, Texas, and clinical assistant professor at the University of Houston College of Medicine.

Generalized pustular psoriasis (GPP) presents as sudden, widespread eruptions of sterile pustules, often accompanied by significant systemic inflammation. It is a rare and potentially life-threatening autoinflammatory disease that accounts for less than 1% of all psoriasis cases. While the name implies generalized pustules, the clinical presentation is heterogeneous, making initial recognition and diagnosis difficult. The panel emphasized that although the classic picture involves widespread erythema studded with sterile pustules, patients may present at different stages of the disease process.

Bhutani elaborated on this variability and said, “Depending on when they present in the course, oftentimes those pustules have already dried out. You might just see these collarettes of scale.... It’s not always your textbook ill patient coming in with a fever and pustules all over their body.” Farberg added that the pustules sometimes look smaller and more yellow on the surface. Beyond the cutaneous findings, systemic involvement is a hallmark. Nguyen highlighted these features, including fever, chills, joint pain, arthralgias, and even vital sign disturbances involving the liver, heart, or kidneys.

“Sometimes these patients have a history of psoriasis, sometimes they don’t, and so that lends [itself to] the challenge of making the right diagnosis,” Nguyen added. Farberg agreed and noted that the pain is what catches patients’ attention and brings them into the clinic.

Navigating Diagnostic Challenges and Triggers

The rarity of GPP directly affects timely diagnosis. As Bhutani pointed out, due to its infrequency, “many people may never have heard of this. In dermatology, we’re lucky to get the education like this and learn from it, but for people in primary care or emergency [departments], oftentimes where these patients are presenting...they’ve never heard of this before, and that obviously leads to delays in diagnosis.”

A primary diagnostic challenge lies in differentiating GPP from other similar-looking conditions, particularly acute generalized exanthematous pustulosis, or pustular drug eruption. Patients often have a history of psoriasis, arthralgias, or arthritis, which can help differentiate. A meticulous history, including medication review and a thorough full-body skin examination, is paramount.

“You have to have all these patients in a gown and check every square inch of their body,” Farberg stressed. Although GPP remains largely a clinical diagnosis, the panel acknowledged the potential use of skin biopsy; however, the first step is clinical impression based on how the patient is looking and feeling. With the potential risk of severe systemic complications, including multiorgan failure and death, early and accurate diagnosis is critical.

Understanding and identifying potential triggers for GPP flares is essential for patient management and counseling. Although triggers can include infections, stress, pregnancy, and certain medications, the panel placed significant emphasis on one particular culprit.

“One of the things that can flare or cause a rebound of the GPP is withdrawal from the corticosteroids. And we live in, unfortunately, a high–systemic corticosteroid world,” Bunick said. He mentioned spesolimab (Spevigo; Boehringer Ingelheim), the first FDA-approved, advanced IL-36 receptor inhibitor that does not harm in the same way systemic steroids do. Infections can also serve as potent triggers.

The Profound Emotional Burden of GPP on Patients

The impact of GPP extends beyond its visible manifestations. The panelists stressed the profound burden this disease places on patients’ lives, especially as pain and itch are significant drivers of morbidity, even in the healing phase. The unpredictable nature of flares and the lack of clear triggers also contribute to psychological distress, which may be the hardest part of disease management, according to Bhutani.

“Patients feel like they’re walking around with a ticking time bomb. They just don’t know when it’s going to go off or if they’re going to do something that’s going to set off a flare.... Even between flare-ups, these patients have a terrible quality of life because they’re just waiting for their disease to flare up,” she explained. Study data have supported this, showing that the quality of life in patients with GPP is much worse than in those with plaque psoriasis. The negative impacts are present in all aspects of daily life, including physical activity, socialization, and work.

This burden also affects the entire family, who may become fearful every time a GPP flare appears, as severe flares can be life-threatening and often require hospitalization. Associated comorbidities, including diabetes, cardiovascular risk factors, arthritis, anxiety, and depression further compound the challenge. Acknowledging and addressing this psychosocial toll is integral to holistic patient care.

Clinical Preparedness and Management Strategies

Given the severity and diagnostic complexities, preparedness is key. Bunick emphasized the need for established clinical workflows for every office and every provider, especially for patients at potential high risk. This will help ease the anxiety of seeing a rare condition and not necessarily knowing what to do.

“The more you see something, the more comfortable you are being able to rapidly diagnose [and] treat. Although GPP is very rare, are you and your office staff prepared to mobilize quickly to help that patient? What are the next steps?” he said. This includes processes for rapid assessment, appropriate workup, navigating insurance hurdles for advanced therapies such as spesolimab, and initiating treatment promptly.

A carefully tailored approach with multidisciplinary collaboration between clinicians can advance treatment success. Additionally, patient education, reassurance, and support are equally vital. Nguyen highlighted the importance of validating the patient’s experience.

“When I first explain the diagnosis of GPP to a patient, I take the time to emphasize to the patient that they are in the right place. We are going to be with them every step of the way, and we understand the impact that the condition has on multiple facets of the patient,” he said. “I try to emphasize how important it is for us to support them through their journey. I want them to feel comfortable talking to me about their quality-of-life impact so that we can get them the right tools or resources to be able to cope with their condition.” Resources such as stress management tools, mental health support, and patient advocacy groups such as the National Psoriasis Foundation can be very valuable.

Future Horizons for Personalized GPP Care in Dermatology

The landscape of GPP management is evolving, offering hope for improved patient outcomes through enhanced awareness, diagnostics, and targeted interventions. The advent of therapies specifically designed to target the underlying pathophysiology, such as spesolimab, marks a significant shift. The drug, supported by Effisayil 1 (NCT03782792) and Effisayil 2 (NCT04399837) trial results, is now approved for both treating acute flares and preventing future ones.

“Prior to spesolimab, it was harder for patients to cope, and there’s a longer period they had to suffer. But the advantage of having an advanced systemic therapy is they don’t have to cope too long. They don’t have to suffer too long if we can get them the medicine fast,” Bunick said.

This therapeutic progress, coupled with potential future advances in diagnostics such as genetic testing for IL36RN mutations, underscores the urgent need for greater clinical preparedness and established treatment guidelines. Bridging the gap between therapeutic innovation and practical implementation through continued education, streamlined diagnostic classification, and efficient office protocols will be crucial. This allows clinicians not only to identify GPP sooner but also to leverage personalized treatments more effectively and mitigate associated comorbidities, moving away from potentially harmful approaches such as broad systemic corticosteroids and toward rapid, targeted relief for patients experiencing this rare condition.

Visible light, particularly high-energy visible (HEV) light, contributes to skin hyperpigmentation, especially in individuals with darker skin tones. Iron oxide formulations in sunscreens offer superior protection against visible light-induced hyperpigmentation compared to non-tinted sunscreens. Despite the popularity of tinted sunscreens, regulatory standards for visible light protection are lacking. Recent research highlights the need for standardized testing and patient education on sun protection. New studies show that mineral-tinted sunscreens with iron oxides and inorganic filters provide better HEV light protection, emphasizing the importance of inclusive photoprotection strategies for diverse skin types.

Aaron Farberg, MD, led a panel exploring the challenges of diagnosing and treating generalized pustular psoriasis and the promise of targeted therapies.

Diagnosing and Managing GPP: Top Insights From the Experts

, Amanda Caldwell, MSN, APRN-C, a dermatology nurse practitioner at US Dermatology Partners and newly inducted president of the 

Society for Dermatology Nurse Practitioners (SDNP),

 shared her commitment to expanding support and educational resources for dermatology NPs and PAs through the revamped SDNP.

Amanda Caldwell, MSN, APRN-C, is fostering community and collaboration for NPs and PAs as the new president of the SDNP.

SDNP President Amanda Caldwell, MSN, APRN-C, on Empowering NPs Through Enhanced Support and Education

Caldwell is enthusiastic about increasing NP engagement in research and education through SDNP. The organization is actively developing partnerships with journals to help members navigate the process of publishing. With a dedicated team behind her, she encourages NPs to reach out and share their goals, interests, and dreams so the organization can provide guidance. In addition to research, SDNP is building out educational tools, including resources on textbooks, apps, and continuing education opportunities. A key initiative under her leadership is to modernize and humanize SDNP, emphasizing accessibility through social media, peer support, and a stronger digital presence.

She also highlights the welcoming, supportive nature of SDNP, especially for those who are unfamiliar with the organization and are considering getting involved. Having discovered SDNP only 3 years ago, Caldwell recalled how attending her first SDNP conference as an introverted newcomer inspired her to become a volunteer.

“I felt welcomed and at home. And I met so many wonderful people across the whole US that I keep in touch with,” she said. “And so instantly after that conference, I felt really empowered and said, ‘OK, I'm ready to change the world. What can I do?’”

Importantly, Caldwell emphasized that SDNP isn’t just for members. Free monthly webinars, open conference access, and strong interprofessional collaboration, including support from physicians, make the organization a valuable resource for NPs and PAs of any level. She believes that thanks to their nursing background, NPs bring a holistic, patient-centered approach to dermatology, which is particularly essential in underserved areas. Caldwell recognizes this and invites all NPs to get involved, take advantage of the resources, and find an empowered community of peers through SDNP.

“It's contagious, it's infectious, and so if you just give it a chance and see, I think we would have everyone hooked,” Caldwell concluded.

Amanda Caldwell, MSN, APRN-C, aims to enhance support and educational resources for dermatology nurse practitioners (NPs) and physician assistants (PAs) through the Society for Dermatology Nurse Practitioners (SDNP). Her initiatives focus on increasing NP engagement in research, modernizing SDNP's digital presence, and fostering a welcoming community. SDNP offers free webinars, open conference access, and interprofessional collaboration, making it a valuable resource for NPs and PAs. Caldwell emphasizes the holistic, patient-centered approach NPs bring to dermatology, especially in underserved areas, and encourages involvement in SDNP.

Amanda Caldwell, MSN, APRN-C, is promoting accessibility, education, and relatability as the newly inducted president of the Society for Dermatology Nurse Practitioners.

From Patient to President: Amanda Caldwell, MSN, APRN-C, And Her Journey with SDNP

Amanda Caldwell, MSN, APRN-C, a dermatology nurse practitioner at US Dermatology Partners, has recently stepped into her role as president of the 

Society for Dermatology Nurse Practitioners (SDNP)

. With a passion for accessible health care and general dermatology, Caldwell brings both personal and professional motivation to her leadership. Having battled skin cancer at age 23, along with other dermatological conditions, her early experience with the specialty drove her commitment to dermatologic care. Caldwell’s vision as president centers on expanding access to high-quality education and career support, not just for nurse practitioners (NPs) but for physician assistants (PAs) as well.

“We're continuing to grow, and I want to be the home for NP dermatology practitioners, but also, we welcome our physician assistant friends too...we’re stronger together,” she emphasized.

Her team’s initiatives include offering free monthly webinars, comprehensive review courses, and new member engagement efforts as part of an SDNP rebrand. She is especially focused on listening to member needs and filling the gaps in the industry, whether it's helping find jobs, working with collaborators, or navigating practice authority.

Caldwell credits much of her professional growth to mentorship, particularly from Christy Parham, MD, MPH, MA, who encouraged her to become a provider, and Mark Fleischman, MD, FAAD, her collaborator at US Dermatology Partners. On a personal level, her mother remains a key source of inspiration. After the sudden loss of Caldwell’s father when she was 12 years old, her mother worked full time and earned a college degree while raising four children, instilling resilience and purpose in Caldwell’s journey.

Among the top issues facing dermatology NPs today, Caldwell identifies limited access to education, unequal pay, and difficulty finding employment in the specialty. She advocates for equal compensation, noting that many NPs practice independently in full practice authority states and manage complex conditions such as autoimmune diseases. Caldwell also aims to boost SDNP’s networking power to connect NPs with job opportunities. Through her leadership, SDNP hopes to reduce barriers and foster professional growth in dermatologic practice.

Above all, she is focused on building a supportive, inclusive home for dermatology NPs and PAs.
“To me, especially with patients and even myself, I think being relatable is important,” Caldwell said. “We're in this world together. Let's help each other out, and if someone knows I've kind of walked in their shoes, it definitely helps build some trust.”

Amanda Caldwell, MSN, APRN-C, has assumed the presidency of the Society for Dermatology Nurse Practitioners (SDNP), driven by her personal and professional experiences in dermatology. Her leadership aims to enhance access to education and career support for nurse practitioners (NPs) and physician assistants (PAs). Initiatives include free webinars, review courses, and member engagement efforts. Caldwell emphasizes mentorship and aims to address challenges like limited education access, unequal pay, and employment difficulties. Her vision is to create a supportive, inclusive community for dermatology NPs and PAs.

Raymond A. Miller, J.D.

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