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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 12, 2025

Seven dermatologists have received GLODERM x CeraVe Access Grants to expand skin care access in underserved communities worldwide.

Expanding Global Access to Dermatology: GLODERM and CeraVe Awards Fuel Community-Driven Change

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. 

Explore the critical need for diversity in hidradenitis suppurativa clinical trials to address health inequities and improve patient outcomes.

Uncovering Inequities in Hidradenitis Suppurativa Trials

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 honor of Melanoma Awareness Month, Glowbar CEO Rachel Liverman spoke to Dermatology Times about this new collaboration, which aims to increase patients' daily sunscreen use by 2026.

Melanoma Research Foundation and Glowbar Join Forces to Fight Skin Cancer

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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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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.

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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.

CT-P39 is Just as Effective as Omalizumab for Chronic Spontaneous Urticaria Treatment

“We’re just beginning to scratch the surface, particularly in dermatology,” said Jason Hawkes, MD, MS, in an interview with 

. “As we start to embrace this back into our specialty, we’re going to start to look at some of these subtypes in hopes of maybe offering better therapies or more consistent therapies that work for more patients.” The subject of this conversation, urticaria, remains a multifaceted dermatological condition, affecting patients in both acute and chronic forms. Hawkes, a dermatologist and principal investigator at the Oregon Medical Research Center, shared his personal and professional experiences with this condition, shedding light on its complexities and the advancements in its treatment.

Hawkes’ journey with urticaria began during his second year of medical school. “I started getting hives and wheals and itching following cold exposures,” he recalled. “Particularly when I would go through the cold and come back into the warm environment, such as the hospital or the clinic, I started breaking out in red splotches.” This was the beginning of his battle with chronic cold urticaria, a condition he would eventually treat in his patients.

Chronic urticaria can be classified into 2 main categories: chronic inducible urticaria (CIU) and chronic spontaneous urticaria (CSU). CIU, as in Hawkes’ case, is triggered by specific stimuli such as cold, heat, or pressure, whereas CSU occurs without a discernible cause. According to Hawkes, approximately 20% of chronic urticaria cases fall under the inducible category. “Not surprisingly, the etiology of these can be quite different, which means their response to therapies can also be different,” he explained.

A unique feature of CIU is the potential for provocation testing. “For example, with cold urticaria, we can put an ice cube on the inner forearm, let it sit for about 5 minutes, and then wait 10 or 15 minutes to see if a wheal forms on those sites,” said Hawkes. However, he notes that these tests are not always definitive. “In my case, I failed the ice cube test, but I had a very consistent exposure and symptom correlation with cold.”

The management of chronic urticaria involves following a structured treatment algorithm, often guided by established guidelines such as those from the American Academy of Allergy, Asthma and Immunology, and international guidelines. Both sets of guidelines emphasize the elimination of triggers and the initiation of second-generation antihistamines as first-line therapy.

Hawkes highlighted the practical application of these guidelines: “I typically have a patient add 1 antihistamine pill every 2 to 3 days. If they’re still having symptoms, [the antihistamine pills] typically will work pretty quickly. So really, within about 1½ to 2 weeks, we can usually get up to that 4-fold dosing. In my experience, they’re either going to respond to that 4-fold dosing of antihistamines or they’re not.”

For patients unresponsive to antihistamines, systemic therapies such as omalizumab are introduced. “My threshold for moving to a systemic therapy is actually very low,” he stated. Omalizumab, a monoclonal antibody targeting immunoglobulin E, has shown significant efficacy in urticaria management.

 “Most patients have a very good response to omalizumab,” Hawkes added, though he acknowledged the need to discuss potential concerns such as injection-related risks with patients.

The landscape of urticaria treatment is rapidly evolving with new therapies on the horizon. Hawkes noted 2 promising options: dupilumab and remibrutinib.

“Dupilumab is very well known to dermatologists and is commonly used for other inflammatory conditions such as atopic dermatitis or prurigo nodularis,” he explained. Late-stage clinical trials have shown that approximately one-third of patients achieve complete resolution of itching and hives with this therapy. Its potential for treating comorbid conditions such as asthma and atopic dermatitis makes it a versatile option for many patients.

 Dupilumab has a Prescription Drug User Fee Act goal date of April 18, 2025. If approved, this would be the first targeted therapy for CSU in more than 10 years.

Remibrutinib, on the other hand, represents a novel approach as a Bruton tyrosine kinase inhibitor. “What we found in the phase 3 trials is this is a therapy that works very, very quickly. In many patients, in a matter of days to a week, we’re seeing pretty dramatic clinical responses,” Hawkes noted. This oral medication targets the intracellular signaling pathway in mast cells, addressing both wheals and the angioedema components of urticaria.

Despite these advancements, Hawkes said there are significant unmet needs in urticaria management. He emphasized the necessity for biomarkers to predict therapy responses. “What we really want to try to tease out is: Can these biomarkers, for example, predict their response to treatment A vs B vs C? That’s really what we don’t have available for these patients,” he said.

Additionally, understanding the diverse presentations of urticaria remains a challenge. “Why do patients with CIU not always respond to therapies for CSU and vice versa?” Hawkes questioned. Differentiating subtypes, such as those with predominant angioedema vs wheal formation, could pave the way for more tailored treatments.

Hawkes’ dual perspective as a clinician and patient provides a comprehensive view of urticaria’s complexities. His personal journey underscores the importance of understanding patient experiences, while his clinical expertise highlights the need for continued research and innovation. As the field progresses, the integration of evidence-based testing, novel therapies, and personalized approaches promises a brighter future for patients with urticaria.

“This is going to be very exciting,” Hawkes concluded. “I hope clinicians will embrace these patients in their practice as we’re going to have a lot more options than we’ve had in the last decade.”

Hives (urticaria) and angioedema overview. American Academy of Allergy, Asthma and Immunology. Accessed January 14, 2025. 

https://www.aaaai.org/tools-for-the-public/conditions-library/allergies/hives-(urticaria)-and-angioedema-overview

Zuberbier T, Abdul Latiff AH, Abuzakouk M, et al. The international EAACI/GA²LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, diagnosis, and management of urticaria. 

Zhao ZT, Ji CM, Yu WJ, et al. Omalizumab for the treatment of chronic spontaneous urticaria: a meta-analysis of randomized clinical trials. 

Maurer M, Casale TB, Saini SS, et al. Dupilumab in patients with chronic spontaneous urticaria (LIBERTY-CSU CUPID): two randomized, double-blind, placebo-controlled, phase 3 trials. 

Dupixent (dupilumab) sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria (CSU). News release. Regeneron. November 15, 2024. Accessed January 14, 2025. 

https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-sbla-accepted-fda-review-treatment-chronic

Jain V, Giménez-Arnau A, Hayama K, et al. Remibrutinib demonstrates favorable safety profile and sustained efficacy in chronic spontaneous urticaria over 52 weeks. 

Urticaria, a complex dermatological condition, presents in acute and chronic forms, with chronic urticaria further divided into chronic inducible urticaria (CIU) and chronic spontaneous urticaria (CSU). Management typically involves antihistamines, with systemic therapies like omalizumab for non-responders. Emerging treatments, such as dupilumab and remibrutinib, show promise. Despite advancements, unmet needs persist, including the need for biomarkers to predict treatment responses. Differentiating urticaria subtypes could lead to more personalized therapies, highlighting the importance of continued research and innovation in this field.

Hawkes discusses urticaria subtypes, treatments, and emerging therapies like dupilumab and remibrutinib.

The Complex World of Urticaria: Insights from Jason Hawkes, MD, MS

2025 American Academy of Allergy, Asthma, and Immunology/World Allergy Organization Joint Congress

, Thomas Casale, MD, presented findings from the LIBERTY-CSU CUPID Study A and Study C, 2 phase 3 trials evaluating dupilumab (Dupixent; Regeneron and Sanofi) in patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1-antihistamine treatment. 

The pooled results demonstrated significant improvements in itch severity and urticaria activity with dupilumab compared to placebo, reinforcing its potential role in CSU management.

, Casale, professor of medicine and pediatrics and chief of clinical and translational research at the University of South Florida, discussed the study's key takeaways, the clinical implications for dermatologists and allergists, and what these findings mean for the future of CSU treatment.

Q: Can you summarize the key findings from the pooled results of these pivotal studies on Dupixent for CSU?

These pooled results confirm what we saw in Study A and Study C: Dupilumab reduced itch and hives and improved disease control compared to placebo in patients with CSU who were uncontrolled on standard of care antihistamines.

Phase 3 trial results presented at AAAAI/WAO 2025 highlight dupilumab's efficacy in reducing itch severity and urticaria activity in CSU patients.

Rachel Liverman

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