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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 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. 

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Explore the top headlines of the week including insights on the latest clinical trials, therapeutic updates, and more.

Dermatology Times' Sunday Crossword: May 11, 2025

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 case you missed it, this week we had news about roflumilast’s dual-site efficacy in psoriasis patients, melanoma care in the United States, phase 2a safety and efficacy results of AX-158, and more.

The Weekly Roundup: May 5-9

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

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Randolph Waldman, MD, is a dual board-certified facial plastic surgeon and the founder of the Waldman Schantz Turner Plastic Surgery Center in Lexington, Kentucky. 

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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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.

Polls 

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.

Q: How did Dupixent perform in terms of symptom relief and overall treatment response compared to placebo?

Patients treated with dupilumab had reductions in both itch severity and urticaria activity. Dupilumab also increased the proportion of patients achieving well-controlled disease or those who had a complete response compared to placebo.

Q: What are the most significant clinical implications of these findings for CSU patients uncontrolled on H1-antihistamines?

Patients with CSU suffer from the unpredictable appearance of hives, which is accompanied by persistent and debilitating itch. Dupilumab reduced both itch and hives compared to placebo which shows its potential as a treatment approach. 

Q: Were there any unexpected outcomes or notable differences in treatment response among patient subgroups?

We didn’t observe any unexpected outcomes in these studies, which is reassuring, and that the results are consistent with what we saw in each individual pivotal trial. The current analysis did not assess patient subgroups, but any potential additional subgroup analyses will be shared in a future scientific forum.

Q: Can you comment on the safety profile observed in the study?

The overall safety was generally consistent with the known safety profile of dupilumab.

Q: How do you see Dupixent fitting into the current CSU treatment paradigm, and what are the next steps for research?

 In these trials, dupilumab was assessed in patients who were uncontrolled on standard-of-care antihistamines, a population that has limited treatment options. Dupilumab is a potential novel treatment approach for these patients and uniquely positioned to address two key drivers of type 2 inflammation, an important biological pathway underlying CSU. Though clinical trials are complete, we will continue to assess the data.

Casale T, Saini S, Bernstein J, et al. Dupilumab improves itch and urticaria activity in patients with chronic spontaneous urticaria: Pooled results from two phase 3 trials (LIBERTY-CSU CUPID Study A and Study C). Abstract presented at: 2025 AAAAI/WAO Joint Congress; February 28-March 3, 2025; San Diego, CA.

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

Q&A: Thomas Casale, MD, Discusses Abstract on Dupilumab and Significant Itch, Hive Reduction in Chronic Spontaneous Urticaria

, Jonathan Bernstein, MD, FAAAAI, presented multiple abstracts on the efficacy of rilzabrutinib in chronic spontaneous urticaria (CSU).

In addition, Bernstein authored an abstract outlining findings from the LIBERTY-CSU CUPID Study A and Study C phase 3 trials evaluating dupilumab (Dupixent; Regeneron and Sanofi) in patients with CSU who remain symptomatic despite H1-antihistamine treatment.

, Bernstein, a physician practicing in Cincinnati, Ohio, explored the studies and their key insights, their clinical impact on dermatologists and allergists, and the implications for the future of CSU treatment.

Q: Your poster at the AAAAI meeting presented real-world treatment patterns among patients with CSU initiating advanced therapies. What key insights emerged from these findings, and how might they impact clinical practice?

In our retrospective analysis, we observed several noteworthy findings. First, add-on therapies were used in the majority of patients across all subgroups, including patients treated with omalizumab (55.9%), which was the most dispensed advanced therapy, systemic anti-inflammatory agents (51.9%), and systemic immunosuppressants (52.9%).

Additionally, the proportion of patients switching treatments was higher with systemic anti-inflammatories (44.3%) and systemic immunosuppressants (51%), compared to omalizumab (16%). However, more than a quarter of all omalizumab-treated patients (26.2%) were being prescribed higher than FDA-approved doses.

Recent studies presented at the 2025 AAAAI/WAO Joint Congress highlight the ongoing challenges and advancements in treating chronic spontaneous urticaria (CSU). Despite existing therapies, many patients remain symptomatic, underscoring the need for new treatments. Real-world data reveal significant use of add-on therapies and frequent treatment switching, particularly with systemic agents. Rilzabrutinib, a novel BTK inhibitor, shows promise in reducing CSU symptoms. The research emphasizes the importance of understanding diverse patient responses and addressing unmet needs, especially in underrepresented populations, to improve CSU management.

At AAAAI/WAO 2025, Bernstein explored new findings on rilzabrutinib and dupilumab in CSU, highlighting treatment gaps and future therapies.

Randolph Waldman, MD

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