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

Daily Derm Times: May 13, 2025

New research reveals a promising strategy to slow type 1 diabetes progression by targeting inflammation with an existing psoriasis drug.

Tyk2 Inhibition Prevents Islet Inflammation and Delays Type 1 Diabetes Development in Mice

Researchers reveal TRIV-509, a novel monoclonal antibody, shows promise in rapidly improving atopic dermatitis by restoring skin barrier integrity and reducing inflammation.

Dual Inhibitor TRIV-509 Shows Promise for Rapid Improvement in Atopic Dermatitis

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. 

Discover how a novel nutraceutical significantly improves mild to moderate acne in a 12-week clinical trial, offering a holistic approach to skin health.

Botanical-Based Nutraceutical Improves Acne

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, MD, FAAD, is president of Skincare Doctors, Cambridge, Massachusetts.

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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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?

, causes the hardening of skin and connective tissues. Often, the disease harms other organs, such as the heart, kidneys, lungs, and gastrointestinal tract, and it can lead to death.

Within the population of people who have systemic sclerosis, those who have diffuse cutaneous systemic sclerosis often have a worse prognosis and higher mortality rate compared to patients with limited cutaneous systemic sclerosis. Early diagnosis and treatment could slow disease progression, but, currently, there is no clinical biomarker to identify patients at risk for worse outcomes.

, at Yale School of Medicine (YSM) and Francesco Del Galdo, MD, PhD, at Chapel Allerton Hospital in the United Kingdom, showed for the first time that a signature of type 1 interferons (IFNs)—a group of proteins involved in cell signaling—can be used as a blood biomarker for patients with diffuse cutaneous systemic sclerosis.

The findings are an important step toward early identification of this high-risk group of patients.

While scleroderma is rare, affecting around 300,000 people in the United States, it can be very serious.

“It has the highest case fatality rate of all the autoimmune rheumatic diseases—worse than rheumatoid arthritis and lupus,” says Hinchcliff, associate professor of medicine (rheumatology, allergy, and immunology) at YSM.

Doctors usually classify patients with suspected systemic sclerosis based on their disease presentation: Those with skin fibrosis below the elbows and knees are considered to have limited cutaneous scleroderma. These patients usually have less severe outcomes than those with the diffuse subtype, where the skin fibrosis spreads above the knees and elbows, and to other parts of the body.

Some patients with the diffuse subtype can become disabled or can develop progressive and debilitating conditions.

“If we catch patients early and treat them more aggressively, we can often prevent bad outcomes,” says Hinchcliff.

To find a reliable marker that can help doctors predict poor outcomes in diffuse cutaneous scleroderma patients, Hinchcliff and clinician scientists from 11 academic centers in the United States partnered to recruit patients with early diffuse cutaneous systemic sclerosis. In 2012, the scientists teamed up to create the U.S. Prospective Registry of Early Systemic Sclerosis (PRESS). The registry consists of patients with early diffuse cutaneous systemic sclerosis who fulfill specific criteria. The new study included 110 PRESS patients.

Around the same time, a group of scientists in the U.K. led by Del Galdo began recruiting another cohort of 32 healthy individuals and 72 patients diagnosed with diffuse cutaneous systemic sclerosis. This cohort was called the Stratification for Risk of Progression in Scleroderma (STRIKE).

High levels of type 1 IFNs are linked to worse outcomes in individuals with autoimmune diseases such as rheumatoid arthritis and lupus. But blood serum levels of type 1 IFNs are difficult to measure. To overcome that challenge, the scientists measured the concentrations of several molecules that appear in response to type 1 IFNs and are abundant enough to measure, thus serving as an indirect measure of type 1 IFNs.

They found that individuals in the PRESS cohort who had high IFN serum scores tended to have worse lung function and disability, such as chronic joint pain, at the beginning of the study and worse lung function during follow-up compared to patients with low IFN serum scores. In the STRIKE cohort, patients with high IFN serum scores had worse lung function than those with low scores, and the differences persisted during follow-up. Across both cohorts, those with high IFN scores also had higher mortality rates than those with lower scores.

Given that scleroderma-related lung disease is the leading cause of death in the scleroderma patient population, the identification of a blood biomarker that may be able to identify patients at heightened risk for lung disease is an important finding.

Hinchcliff believes that the high serum IFN score may one day be useful in predicting which patients in the early stages of their disease are at risk for ultimately developing severe disease, allowing for more personalized and effective treatments.

“These are people at high risk, and we really need to be focused on monitoring them closely and treating them aggressively before lung damage occurs,” Hinchcliff says.

“Our results suggest that measuring type I IFN activity is akin to assessing the fuel driving autoimmune processes in systemic sclerosis patients,” she adds. While additional validation and testing are necessary, “the ability to possibly discriminate between high-risk and low-risk patients with diffuse cutaneous systemic sclerosis using a blood test represents a large step forward for the community.”

 was supported by the National Institute of Arthritis Musculoskeletal and Skin Diseases (awards P30AR061271, R01AR073270,

R01AR073208, K24AR080217, P30AR070254, R01AR073284, and

R01AR081280) and the National Heart, Lung, and Blood Institute (award R01HL152677). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Additional support came from the National Scleroderma Foundation, the National

Institute of Health Research–Leeds Biomedical Research Centre, the Kennedy Trust for Rheumatology Research, and the U.S. Department of Defense.

 is a writer for the Yale School of Medicine Editorial Department.

Systemic sclerosis, particularly the diffuse cutaneous subtype, poses significant health risks, including organ damage and high mortality. Recent research has identified type 1 interferons (IFNs) as a potential blood biomarker for early detection of high-risk patients. This discovery could enable more personalized treatment strategies, potentially improving outcomes by identifying patients at risk for severe disease progression, especially lung-related complications. The study, supported by various health institutes, highlights the importance of early diagnosis and aggressive treatment to mitigate the disease's impact.

Researchers identify a blood biomarker linked to worse outcomes in diffuse cutaneous systemic sclerosis, paving the way for early detection and treatment.

Test Could Help Identify Patients at Risk for Severe Scleroderma

At the Society for Investigative Dermatology 2025 Annual Meeting in San Diego, California, Artax Biopharma shared Phase 2a late-breaking trial results 

 of AX-158, a first-in-class oral Nck modulator for patients with mild to moderate plaque psoriasis.

“We’re highly encouraged by the safety profile observed in our Phase 2a study and the notable impact of our oral Nck modulator AX-158 on key disease biomarkers and clinical severity scores,” Rob Armstrong, PhD, Chief Executive Officer of Artax, said in a statement. “These results further support the potential of AX-158 to offer a truly novel mechanism to modulate TCR signaling rather than inhibit it, and we’re committed to continuing to advance this promising candidate to meet the unmet needs of patients with T cell-mediated autoimmune diseases.”

The investigational oral, small molecule immunomodulator, which acts as a T cell receptor, was tested among 31 participants between the ages of 18 and 60 at multiple centers in the UK. In the prospective, randomized, double-blind, placebo-controlled study, participants were randomized 2:1 to receive a single daily dose of 10mg AX-158 (

 = 10) for 28 days. A 30-day safety period was also initiated at the conclusion of the trial. The first patient was dosed in 

“From my blinded analysis of the patient samples in this phase 2a study, it is clear that AX-158 shows a clear impact on T cells and related biomarkers in this patient population,” James Krueger, MD, PhD, Head of Laboratory for Investigative Dermatology at the Rockefeller University and member of the Scientific Advisory Board at Artax, said.

AX-158 10 mg was found to be safe and well-tolerated with no Grade ≥ 3 treatment-related adverse effects and no serious or opportunistic infections. There was a single incidence of Grade 2 neutropenia in the arm (4.8%). None of the participants discontinued the therapy due to adverse events.

Patients with moderate disease, a Psoriasis Area and Severity Index (PASI) of >6, showed a positive response trend (34.6%). At the conclusion of the trial, only the patients who received AX-158 reached PASI50 or greater. These safety and efficacy findingscorrespond with what was observed in previous phase 1 study.

According to longitudinal skin biopsies, the number of CD8+ T cells was reduced significantly in patients treated with AX-158. In extended RNAseq analysis, the responder group showed 52% improvement in pathologic IL-17A levels. More specifically, 281 psoriasis-related gene sets were significantly downregulated (

 < 0.05). The biomarker analyses also showed statistically significant impacts on the IL-17 and IL-12 signaling pathways, validating Nck immunomodulation for psoriasis and potentially other autoimmune diseases.

Unlike traditional autoimmune therapies that broadly shut down immune responses, Nck modulators increase T cell tolerance to self-antigens while simultaneously preserving their normal immune function against foreign pathogens. According to the abstract, AX-158 may help prevent self-reactive T cell responses that drive autoimmune pathobiology. It has the capability to be used as monotherapy or in combination with another therapy.

Scott Batty, MD, Chief Medical Officer of Artax, concluded, “We are deeply grateful to the investigators, their teams, and all the participants who made this progress possible. AX-158 has a unique mechanism of action that modulates TCR signaling to restore tolerance to self while maintaining response against pathogens. We are excited to continue advancing AX-158 and exploring its broad potential across T cell-driven autoimmune diseases, including atopic dermatitis and rheumatoid arthritis.”

1. Artax Biopharma presents Phase 2a results for oral Nck modulator AX-158 in late-breaking session at the Society for Investigative Dermatology 2025 Annual Meeting. Globe Newswire. May 9, 2025. Accessed May 9, 2025. 

https://www.globenewswire.com/news-release/2025/05/09/3078045/0/en/Artax-Biopharma-presents-Phase-2a-results-for-oral-Nck-modulator-AX-158-in-late-breaking-session-at-the-Society-for-Investigative-Dermatology-2025-Annual-Meeting.html

2. Artax announces first patient dosed in phase 2a psoriasis trial evaluating AX-158. News release. PR Newswire. February 13, 2024. Accessed May 9, 2025. 

https://www.prnewswire.com/news-releases/artax-announces-first-patient-dosed-in-phase-2a-psoriasis-trial-evaluating-ax-158-302060157.html

Artax Biopharma presented promising Phase 2a trial results for AX-158, an oral Nck modulator, at the Society for Investigative Dermatology 2025 Annual Meeting. The study involved 31 participants with mild to moderate plaque psoriasis, demonstrating a favorable safety profile and significant impact on disease biomarkers and clinical severity scores. AX-158 showed potential in modulating TCR signaling, reducing CD8+ T cells, and downregulating psoriasis-related gene sets. The findings suggest AX-158 could be a novel treatment for T cell-mediated autoimmune diseases, offering a unique mechanism of action compared to traditional therapies.

The promising safety and efficacy results were presented at the Society for Investigative Dermatology 2025 Annual Meeting.

Artax Presents Phase 2a Results of AX-158 for Plaque Psoriasis

The lip augmentation market is projected to reach a value of 11.6 billion USD by 2030.

 Although hyaluronic acid fillers are the most common type of lip procedure, an alternative method, the “lip flip,” has grown in popularity in recent years, with the #lipflip hashtag gaining 64.4 million views on TikTok as of July 2021.

 A lip flip involves injecting botulinum neurotoxin A (BoNT-A) into the superior orbicularis oris muscle, forming a more natural “pout” in the upper mouth. The technique is less expensive than a traditional dermal lip filler, but the effects have a more temporary duration of 8 to 12 weeks. Both methods have similar adverse effects of swelling and bruising at the injection site, but lip flips do not require much aftercare post-procedure.

“’Lip flips’ are ideal for patients who desire fuller lips but do not want lip fillers, have excessive gingival display while smiling, have an upper lip that retracts with their smile, or prefer relatively short-term or temporary results,” according to the study authors.

A novel longitudinal analysis evaluated shifts in public interest over the past decade regarding these minimally invasive lip augmentation strategies.

 Investigators used the Google Trends database to evaluate the historical monthly search volumes of “lip filler” and “lip flip” from January 2014 to January 2024.

Both search terms had similar increases in engagement across the 10-year period. However, lip filler was searched more consistently with an average 75% increase in relative search volume per month. Conversely, lip flip had a mean increase of 33%. Furthermore, the relative search volumes were quantified as 12.1 for lip flip and 30.4 for lip filler, giving “lip flip” a consistently lower Google search volume over time (

Even with these differences, both terms saw similar patterns across the years. For example, both saw a rapid decline at the onset of the COVID-19 pandemic,  between February 2020 and April 2020. Conversely, between September 2022 and February 2023, there was a stark increase in both categories' searches.

Even as lip flips grow in public interest, it still remains secondary to lip filler, according to this data. The research is limited, however, as the sole use of Google Trends does not provide information on patient factors like demographics, satisfaction, and outcomes. Including clinical surveys and data in future research could bolster these results and provide a more nuanced perspective on these procedures.

“This reveals a need for future research surrounding patient and physician education on minimally invasive lip augmentation procedures and what deciding factors are considered, such as safety, cost, or convenience,” the authors concluded. “It also emphasizes the need for future research assessing sociodemographic factors that play a role in cosmetic lip augmentation, ultimately allowing us to understand better the populations seeking these procedures and their accessibility.

Do you prefer lip filler or lip flips? Let us know your thoughts and experiences by answering our poll above and commenting on social media, or by writing to us at 

1. Grandview Research, “Lip Augmentation Market Size to Reach $11.61Bn By 2030,” (2023), 

https://www.grandviewresearch.com/press-release/global-lip-augmentation-market.

2. D. Shira, “Considering a Lip Flip? Here's Why Experts Say Proceed With Caution,” (2024), 

www.forbes.com/sites/dahvishira/2024/02/21/considering-a-lip-flip-heres-why-experts-say-proceed-with-caution/

3. Bourmand R, Olsson SE, Soleimani S, Fijany A. Lip Filler Versus "Lip Flip": Longitudinal Public Interest and a Brief Review of Literature. 

. 2025;24(2):e70048. doi:10.1111/jocd.70048

The lip augmentation market is expected to reach $11.6 billion by 2030, with hyaluronic acid fillers being the most common procedure. However, the "lip flip," which uses botulinum neurotoxin A, is gaining popularity due to its natural appearance and lower cost, despite its temporary effects. A longitudinal analysis using Google Trends showed that while both "lip filler" and "lip flip" searches increased over the past decade, lip fillers consistently had higher search volumes. The study highlights the need for further research on patient demographics and satisfaction to better understand these procedures.

Share your thoughts by answering today’s poll and read about these popular aesthetic techniques for lips.

POLL: “Lip Flips” or Lip Filler? Analyzing the Latest Trends in Lip Augmentation 

A phase 3 trial compared the efficacy of CT-P39 to omalizumab for the treatment of chronic spontaneous urticaria (CSU).

 Both were equally effective and had similar safety profiles when added on to second-generation H

-antihistamine therapy. CT-P39 is an omalizumab biosimilar approved by the European Commission.

The phase 3, double-blind, randomized, active-controlled study (

) took place in 64 centers across 6 countries. It included male and female patients between the ages of 12 and 75. Each had a CSU diagnosis of ≥ 6 months with active hives and itching for 6 weeks, despite the use of H

-antihistamines. They also had a weekly itch severity score (ISS7) of ≥ 8 points and a weekly urticaria activity score (UAS7) of ≥ 16 points. The mean ISS7 and UAS7 at baseline ranged from 15.27 to 15.77 and 31.04 to 32.46, respectively.

The study consisted of a 4-week screening period, 2 12-week treatment periods, and a 16-week follow-up. In the first treatment period, 619 patients received 150 mg or 300 mg of either CT-P39 or the reference omalizumab (ref-OMA). With a ratio of 2:2:1:1, the breakdown is as follows:

In the second period, these 4 patient groups were randomized 1:1. Participants taking ref-OMA 300 mg were rerandomized to take CT-P39 300 mg or ref-OMA 300 mg while those who were originally taking CT-P39 300 mg continued the dosage. Additionally, patients taking 150 mg of either drug were upped to the 300 mg dosing.

Participants received the drug subcutaneously at weeks 0, 4, 8, 12, 16, and 20. They also completed eDiaries in the morning and evening for the entirety of the study. Investigators assessed the changes in ISS7 and UAS7 at week 12 as the primary endpoint. The Dermatology Life Quality Index (DLQI) and Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) were used to evaluate quality of life.

The average ISS7 and HSS7 decreased in all groups, representing equivalent efficacy. There were also improvements in quality of life, angioedema-free days, and rescue medication use for all dosages. Additionally, switching from ref-OMA 300 mg to CT-P39 300 mg at week 12 did not impact overall efficacy.

At the end of the first treatment period, responses were comparable in the ref-OMA 300 mg group (40.5% and 30.7%, respectively) to the CT-P39 300 mg group (37.9% and 23.6%, respectively). This continued in the second period with the CT-P39 300 mg cohort at 54.5% and 40.1% versus the ref-OMA 300 mg cohort at 47.9% and 37.5%.

Adverse events were also comparable in all groups during both treatment periods, making CT-P39 well-tolerated. The most frequently reported were COVID-19 infections and nasopharyngitis. Most adverse effects were not new or unexpected based on previous trials and remained at Grade 1 or 2 in intensity. Drug discontinuation occurred in 6 participants: 4 in the CT-P39 cohort and 2 in the ref-OMA 300 mg group.

The short study duration and lack of racial diversity may impact the generalizability of the results. Nonetheless, this trial suggests that CT-P39 is a promising omalizumab biosimilar for a disease that affects approximately 1% of the population.

“These are the first reported results for a biosimilar in CSU,” the authors wrote. “Further long-term studies are warranted in larger cohorts, to validate our findings and identify potential factors affected with treatment response.”

1. Saini SS, Maurer M, Dytyatkovska Y, et al. CT-P39 Compared With Reference Omalizumab in Chronic Spontaneous Urticaria: Results From a Double-Blind, Randomized, Active-Controlled, Phase 3 Study.

Published online January 9, 2025. doi:10.1111/all.16446

2. Celltrion Inc, “Celltrion Receives European Commission Approval of Omlyclo® (CT-P39), the First and Only Omalizumab Biosimilar Approved in Europe [Press Release],” 2024, 

https://celltrion.com/en-us/company/media-center/press-release/3246

3. Kolkhir P, Muñoz M, Asero R, et al. Autoimmune chronic spontaneous urticaria. 

. 2022;149(6):1819-1831. doi:10.1016/j.jaci.2022.04.010

A phase 3 trial evaluated the efficacy and safety of CT-P39, an omalizumab biosimilar, compared to omalizumab in treating chronic spontaneous urticaria (CSU). Conducted across 64 centers, the study involved 619 patients with CSU unresponsive to H1-antihistamines. Results showed that CT-P39 and omalizumab had equivalent efficacy and safety profiles, with improvements in quality of life and symptom scores. Adverse events were similar across groups, with most being mild. The study's limitations include short duration and lack of racial diversity, necessitating further research for broader validation.

According to a phase 3 study, the omalizumab biosimilar saw comparable results with a good safety profile.

Ranella Hirsch, MD, FAAD

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