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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 is now finishing her Masters in Digital Media through Ohio University. When she's not writing, Maddi loves to read, attend concerts and spend time with her family.

Articles

Hawkes shared his excitement for the near future of dermatology, recognizing the increasing ability to provide tailored care to patients. 

Jason Hawkes, MD, MS: Looking Back on 2024, Ahead to 2025

Kaitlyn Bader is the assistant managing editor of 

 and joined the MJH Life Sciences team in June 2022. She attended Otterbein University in Westerville, Ohio, and earned a Bachelor of Arts degree in literary studies with minors in creative writing and film studies. Prior to health care news, Kaitlyn worked in industrial marketing. She enjoys cooking, reading, and tending to her house plants.

Experts highlight the versatility and patient-centered approach of PDT with red light, emphasizing its effectiveness for AK, skin rejuvenation, and superficial cancers.

Enhancing Photodynamic Therapy With Red Light Applications, Patient Comfort, and Seasonal Trends

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.

Experts discussed the challenges of managing GPP and highlight a pivotal study on the subcutaneous formulation of spesolimab, demonstrating its potential to prevent GPP flares and improve patient outcomes despite some limitations.

Fighting the Flare of GPP: Expert Insights on Spesolimab

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.

In a meta-analysis of over 61 million participants, it was found that AD patients have a 37% risk of developing IBD and similar conditions.

Patients with Atopic Dermatitis Are More Susceptible to Developing Inflammatory Bowel Disease

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Dermatologist Jeffrey S. Dover, MD, practices with 14 dermatologists and nearly 100 staff at SkinCare Physicians in Chestnut Hill, Mass.

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.

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Video Series

Cabtreo (Ortho Dermatologics; formerly known as IDP-126) was approved by the US Food and Drug Administration

 (FDA) in October 2023 for the treatment of patients aged 12 years and older with acne vulgaris. Cabtreo is the first FDA-approved fixed-dose triple-combination gel (clindamycin 1.2%/adapalene 0.15%/benzoyl peroxide 3.1%) for patients with acne. Cabtreo is expected to be available in Q1 of 2024.

, more than half (52.5%) of patients treated with Cabtreo achieved treatment success as measured by a 2-point or greater reduction from baseline in Evaluator’s Global Severity Score and clear or almost clear skin. In the first of the phase 3 trials, the proportion of patients treated with Cabtreo achieving clear or almost clear skin (49.6%) was significantly greater than patients being treated with a vehicle gel (24.9%). The second phase 3 trial demonstrated consistent significant rates of treatment success among Cabtreo- treated patients (50.5%) versus patients in the vehicle gel group (20.5%).

What are your thoughts about Cabtreo as the newest acne topical? Email us at 

Cabtreo, a fixed-dose triple-combination gel, received FDA approval in October 2023 for treating acne vulgaris in patients aged 12 and older. It combines clindamycin, adapalene, and benzoyl peroxide, marking the first such approved formulation. Clinical trials demonstrated its efficacy, with over half of the patients achieving significant improvement in acne severity. Phase 3 trials showed Cabtreo's superiority over a vehicle gel, with nearly 50% of patients achieving clear or almost clear skin. Cabtreo is anticipated to be available in the first quarter of 2024.

Click here to answer this week's acne poll.

Polls 

POLL: Have Your Patients Asked About Cabtreo for Acne?

Prurigo nodularis (PN) is a chronic skin disorder characterized by multiple firm nodular lesions, often symmetrically distributed on areas of the skin that are accessible to scratching.

 A history of scratching, picking, or rubbing has been identified as one of the core symptoms of PN and can have a notable impact on patient quality of life.

PN can be mistaken for various disorders, including Kyrle disease, bullous pemphigoid, neurotic excoriations, hypertrophic lichen planus, and atopic dermatitis with lichen simplex chronicus.

 When assessing skin biopsy results, histopathologic features such as pseudoepitheliomatous hyperplasia, hypergranulosis in the epidermis, focal parakeratosis, and thick compact orthohyperkeratosis can be characteristic of PN.

The pathophysiology of PN is not fully understood but current evidence suggests that its underlying mechanism stems from the intersection of neural dysregulation and immunological dysfunction.

 Translational studies over the past 15 years have revealed new insights into the pathogenesis of the disease, leading to the identification of specific immunological pathways that play an important role in the disease.

 Specifically, Th2-associated cytokines such as IL-31 and IL-4 have been identified as therapeutics targets, leading to the FDA approval of the IL-4 and IL-13 inhibitor dupilumab (Dupixent) in 2022 and the IL-31 inhibitor nemolizumab (Nemluvio) in 2024, both indicated for the treatment of adult patients with PN.

As more therapeutic options become available for PN, a high need remains for increased awareness of the disease and its impact, which could yield earlier and/or more accurate and diagnosis and treatment. To that end, inquiries into the impact of PN have increasingly articulated its economic, comorbidity, and quality of life burden.

According to findings published in 2023, patients with PN have been found to have higher rates of comorbidities, including not only atopic dermatitis but also chronic hepatitis C, chronic kidney disease, congestive heart failure, chronic obstructive pulmonary disease, depression, and type 2 diabetes.

 Findings from a recent retrospective analysis presented at the 2024 Fall Clinical Dermatology Conference showed that patients were more likely to have been newly diagnosed with a comorbidity vs matched controls. Among comorbidities identified in patients with PN were other dermatologic conditions (such as atopic dermatitis), as well as attention-deficit/hyperactivity disorder, autism, autoimmune disease, metabolic disease, and sleep disorders.

 Patients with PN were also found to have significantly higher costs, likely exacerbated by the increased prevalence of comorbidities. These results echo previously published data showing that patients with PN are also more likely than the general population to have longer hospital stays and increased cost of care.

One key observation from the investigators of the recently presented data at Fall Clinical Dermatology Conference is that many patients with PN are receiving treatment for the mental health symptoms of PN, while many could benefit from treatments that address autoimmune and inflammatory aspects of the disease. They also highlighted the need for more effective measures to address these burdens in this patient population.

Given the increased knowledge regarding the pathogenesis of PN as well as the associated economic, comorbidity, and quality-of-life burden on patients, the need for greater awareness of the disease in the clinical community and among patients is clearer. As we learn more about the mechanisms of disease, patients must be educated about their disease, the importance of appropriate treatment, and the availability of systemic agents that may offer benefits.

One organization that is raising awareness about PN is the Prurigo Nodularis League, which was founded in 2014 and serves as a mutual platform for clinicians and patients to raise global awareness and provide news relating to PN. League members are regularly informed about the results of current studies and news about diagnostics and treatment. Visit 

The next article in this series on prurigo nodularis will explore the data for available and emerging systemic agents.

Elmariah S, Kim B, Berger T, et al. Practical approaches for the diagnosis and management of prurigo nodularis: United States expert panel consensus. 

. 2021;84(3): 747-760. doi:10.1016/j.jaad.2020.07.025

Müller S, Zeidler C, Ständer S. Chronic prurigo including prurigo nodularis: new insights and treatments. 

. 2024;25(1):15-33. doi:10.1007/s40257-023-00818-z

Labib A, Ju T, Vander Does A, Yosipovitch G. Immunotargets and therapy for prurigo nodularis. 

Joel MZ, Hydol-Smith J, Kambala A, Cornman H, Kwatra SG. Prevalence and comorbidity burden of prurigo nodularis in United States adults enrolled in All of Us research program. 

. 2023;89(5): 1056-1058. doi:10.1016/j.jaad.2023.06.045

Elmariah SB, Princic N, Richards M, et al. Economic and comorbidity burden of prurigo nodularis and drivers of higher healthcare costs in the US: a retrospective analysis of claims data of patients diagnosed between 2017 and 2022. Poster presented at: 44th Annual Fall Clinical Dermatology Conference; October 24-27, 2024; Las Vegas, NV

Whang KA, Kang S, Kwatra SG. Inpatient burden of prurigo nodularis in the United States. 

. 2019;6(3): 88. doi:10.3390/medicines6030088

Increased awareness for prurigo nodularis may help to usher in a new era of timelier and more targeted treatment.

The Burden of Prurigo Nodularis

Galderma announced Friday that the US Food and Drug Administration (FDA) has approved nemolizumab (Nemluvio) for the treatment of moderate to severe atopic dermatitis (AD) in patients aged 12 years and older with a history of inadequate response to topical therapies.

 Nemolizumab is now indicated for combined use with topical corticosteroids and/or calcineurin inhibitors for this patient population.

This approval follows nemolizumab's prior FDA approval in August 2024 for prurigo nodularis.

The approval was based on posiitve results from the phase III ARCADIA clinical program. This double-blind, placebo-controlled trial included 1,728 patients aged 12 years and older with moderate to severe AD. Patients received subcutaneous nemolizumab every 4 weeks alongside background topical corticosteroids, with or without topical calcineurin inhibitors, and were evaluated against placebo groups.

Researchers observed statistically significant improvement in achieving "clear" (0) or "almost clear" (1) skin at week 16, as well as a 75% reduction in eczema severity.

Significant reductions in itch were reported as early as week 1, and patients experienced meaningful reductions in sleep disturbance. Nemolizumab was well-tolerated, with a safety profile consistent with placebo.

Nemolizumab is the first monoclonal antibody targeting interleukin (IL)-31 receptor alpha, a pathway critical to itch and inflammation in AD. By inhibiting IL-31 signaling, nemolizumab provides a targeted approach to alleviate these symptoms and improve skin health.

Flemming Ørnskov, MD, MPH, CEO of Galderma, emphasized the innovation behind this approval.

"As just one example of our innovative, science-based pipeline, Nemluvio is an important and effective new treatment option for patients with atopic dermatitis, where unmet needs remain," Ørnskov said in a news release.

 "Another key milestone on Galderma’s journey, this FDA approval will accelerate the ongoing growth of our US organization and our Therapeutic Dermatology Business, and underscores our commitment to delivering innovative first-in-class solutions to patients across the full spectrum of the fast-growing dermatology market."

Professor Jonathan Silverberg, MD, PhD, MPH, lead investigator and dermatology expert at George Washington University, highlighted the trial’s outcomes.

"Despite currently available treatment options, atopic dermatitis continues to have a massive impact worldwide, with patients not only burdened by intense itch and recurrent skin lesions, but also potentially several associated symptoms including sleep issues, pain, anxiety, and depression. I look forward to being able to offer this option to atopic dermatitis patients in my practice who are seeking relief from burdensome itch and lesions," he said.

Galderma receives US FDA approval for Nemluvio (nemolizumab) for patients with moderate-to-severe atopic dermatitis. News release. Galderma. December 14, 2024. Accessed December 16, 2024. 

https://www.galderma.com/news/galderma-receives-us-fda-approval-nemluvior-nemolizumab-patients-moderate-severe-atopic

Galderma receives US FDA approval for Nemluvio (nemolizumab) for adult patients living with prurigo nodularis. News release. Galderma. August 13, 2024. Accessed December 16, 2024. 

https://www.galderma.com/news/galderma-receives-us-fda-approval-nemluvior-nemolizumab-adult-patients-living-prurigo#:~:text=Zug%2C%20Switzerland%20%E2%80%93%20August%2013%2C,of%20adults%20with%20prurigo%20nodularis

Nemolizumab is intended for use in combination with topical corticosteroids and/or calcineurin inhibitors in this indication.

ICYMI: FDA Approves Galderma's Nemolizumab for Moderate to Severe Atopic Dermatitis in Patients 12 and Older

The US Food and Drug Administration (FDA) announced today that it has approved tapinarof cream, 1% (Vtama; Organon) for patients aged 2 years and older with atopic dermatitis (AD).

The approval is supported by positive data stemming from the phase 3 ADORING 1 and 2 studies, a pharmacokinetics trial in children, and interim results from the ongoing ADORING 3 trial.

“With the FDA’s approval of VTAMA cream in atopic dermatitis for adults and children as young as 2 years old, there is now a therapy that offers the potential for powerful skin clearance with no label warnings or precautions, contraindications, and no restrictions on duration of use or percentage of body surface area affected,” said Kevin Ali, Organon’s Chief Executive Officer, in a statement. “Introducing this new first-in-class therapy for AD patients reaffirms Organon’s commitment to addressing areas of high unmet need.”

In the ADORING studies, patients saw an improved Validated Investigator Global Assessment for AD score of clear (0) or almost clear (1) from baseline at week 8. In ADORING 1, 45.4% of patients achieved this while 46.4% reached this outcome in ADORING 2, versus 18% of patients on vehicle (p < 0.0001). Participants who received tapinarof cream compared to those who received vehicle saw at least a 75% improvement in Eczema Area and Severity Index score and a ≥4-point improvement in Peak Pruritus Numerical Rating Scale. Itch relief was rapid, with patients and caregivers reporting improvement as early as 24 hours after the first application.

The aryl hydrocarbon receptor agonist was well-tolerated with ≥1% incidence of adverse events. The most commonly reported adverse effects were upper and lower respiratory tract infection, folliculitis, headache, asthma, vomiting, ear infection, pain in extremities, and abdominal pain.

The approval also was supported by data from ADORING 3, a 48-week open-label, long-term extension study. This trial included 728 eligible participants from ADORING 1, ADORING 2, a 4-week pharmacokinetics trial, and direct enrollees who were naive to tapinarof. 378 patients achieved complete disease clearance and discontinued treatment, with a mean duration of the first treatment-free interval of about 80 consecutive days. Patients whose AD returned were retreated until clearance was achieved. The long-term safety profile was consistent with the safety profile observed at week 8, even on affected sensitive skin areas.

In a press release, Adelaide A. Hebert, MD, Professor and Chief of Pediatric Dermatology at McGovern Medical School at UTHealth Houston and Children’s Memorial Hermann Hospital and lead investigator for the ADORING program, said, “VTAMA cream has the potential to bring much needed relief to a significant number of children suffering from this disease. Moreover, because the prevalence of itch makes this condition extremely burdensome to patients and their families, the itch data from the ADORING program demonstrates reduction of one of the condition’s most prevalent symptoms with use of VTAMA cream."

Dermavant Sciences announced its supplemental New Drug Application (sNDA) submission for this drug and indication in April.

 However, in November, the FDA announced it had extended the target action date for the sNDA for tapinarof cream, 1% by 3 months, shifting the Prescription Drug User Fee Act date to March 12, 2025.

 The extension stemmed from the FDA’s request for additional long-term study data but did not reflect concerns about the drug’s safety or efficacy.


1. FDA Approves VTAMA® (tapinarof) cream, 1% for the Treatment of Atopic Dermatitis in Adults and Children 2 Years of Age and Older. News release.BusinessWire. December 16, 2024. Accessed December 16, 2024. 

https://www.organon.com/news/fda-approves-vtama-tapinarof-cream-1-for-the-treatment-of-atopic-dermatitis-in-adults-and-children-2-years-of-age-and-older/

2. Dermavant announces FDA acceptance of supplemental new drug application (sNDA) for Vtama (tapinarof) cream, 1% for the treatment of atopic dermatitis in adults and children 2 years of age and older. News release. Dermavant Sciences. April 29, 2024. Accessed December 13, 2024. 

https://dermavant.com/dermavant-announces-fda-acceptance-of-supplemental-new-drug-application-snda-for-vtama-tapinarof-cream-1-for-the-treatment-of-atopic-dermatitis-in-adults-and-children-2-years-of-age-and-old/

3. Update on FDA review of Vtama (tapinarof) cream 1% for the treatment of atopic dermatitis in adults and children 2 years of age and older. News release. BusinessWire. November 5, 2024. Accessed December 13, 2024. 

https://www.businesswire.com/news/home/20241105332994/en/Update-on-FDA-Review-of-VTAMA%C2%AE-tapinarof-Cream-1-for-the-Treatment-of-Atopic-Dermatitis-in-Adults-and-Children-2-Years-of-Age-and-Older

The approval is based on positive data stemming from the ADORING clinical trial program.

FDA Approves Tapinarof Cream, 1% for Atopic Dermatitis in Patients 2 Years and Older

It was announced today that Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for roflumilast cream 0.05% (Zoryve).

 This new indication is targeted for patients between the ages of 2 and 5 for the treatment of mild to moderate atopic dermatitis (AD). Pediatric patients saw a rapid reduction in itch and a meaningful overall clearance of disease.

“When choosing a therapy for very young children living with AD, healthcare providers and caregivers have to account for unique considerations for pediatric patients, including sensitive skin, and select a medication that is appropriate for long-term use by a child with a chronic skin condition. Data from the pivotal trial demonstrated that roflumilast cream 0.05% provided consistent and rapid relief, and was well-tolerated,” Rocco Serrao, MD, FAAD, of DOCS Dermatology and INTEGUMENT-PED and INTEGUMENT-OLE investigator, said in a statement. “If approved, roflumilast cream 0.05% would offer a new topical option with the potential to advance the standard of care for these young patients, offering fast relief to the children and their families from the onerous symptoms of AD.”

The submission to the FDA is supported by positive results from the pivotal phase 3, vehicle-controlled, INTEGUMENT-PED trial, as well as a long-term extension study and a phase 1 pharmacokinetic study. The INTEGUMENT-PED research included 652 children aged 2 to 5 with a mean AD body surface area of 22% and a range between 3% and 82%. Compared to the 10.7% of children treated with vehicle, 25.4% of patients saw a 2-grade improvement from baseline and achieved a score of “clear” or “almost clear” at week 4, according to the validated Investigator Global Assessment – Atopic Dermatitis scale (

 < 0.0001). Some significant improvements were seen as early as week 1, with all secondary endpoints being met. Additionally, 35.3% of participants with a baseline Worst Itch Numeric Score of ≥ 4 achieved a 4-point reduction in the 4th week, compared to 18.0% of vehicle-treated children (nominal 

Overall, the once-daily, phosphodiesterase 4 (PDE4) inhibitor was well-tolerated, with a safety profile that was consistent in adult and older pediatric patients treated with roflumilast cream 0.15% with mild to moderate AD. The most frequent adverse effects were upper respiratory tract infection, diarrhea, and vomiting.

The submission is also supported by data from the open-label, INTEGUMENT-OLE extension study, in which 562 pediatric patients were treated for up to 52 weeks. Roflumilast cream 0.15% is currently approved by the FDA for the treatment of mild to moderate AD in patients 6 years of age and older. The 0.3% cream version is also FDA-approved for plaque psoriasis treatment.

Frank Watanabe, president and CEO of Arcutis, said in a press release, “Parents, caregivers, and healthcare professionals need to feel confident in their treatment plan. Our clinical development program for ZORYVE reinforces the well-established efficacy, safety, and tolerability profile of roflumilast cream, which was designed to deliver the drug without disrupting the skin barrier or using sensitizing excipients and irritants. This lower concentration of roflumilast cream was intentionally formulated for the needs of younger children with AD and demonstrates our commitment to serving this vulnerable patient population. We look forward to the opportunity to offer ZORYVE cream 0.05%, if approved, as a new topical therapy for the 1.8 million children between the ages of 2 to 5 with AD and their families.”

1. Arcutis Submits ZORYVE® (roflumilast) Cream 0.05% Supplemental New Drug Application to the FDA for the Treatment of Children Aged 2 to 5 with Mild to Moderate Atopic Dermatitis. News release. Arcutis Biotherapeutics, Inc. December 16, 2024. Accessed December 16, 2024. 

https://www.globenewswire.com/news-release/2024/12/16/2997469/0/en/Arcutis-Submits-ZORYVE-roflumilast-Cream-0-05-Supplemental-New-Drug-Application-to-the-FDA-for-the-Treatment-of-Children-Aged-2-to-5-with-Mild-to-Moderate-Atopic-Dermatitis.html

The supplemental New Drug Application is supported by positive results from the INTEGUMENT-PED and INTEGUMENT-OLE trials.

Jeffrey S. Dover, M.D.

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