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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. 

Articles

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

The Rx Recap: June 29-July 4

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 the FDA's RPD Designation of QRX003 for Netherton Syndrome, Galderma's 2 new clinical trials of nemolizumab, Allergan Aesthetics' sPMA for SKINVIVE by Juvéderm, and more.

The Weekly Roundup: June 30-July 3

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.

Put your dermatology expertise to the test with Dermatology Times’ interactive quiz series!

Dermatology Times Spot Test: July 3, 2025

Robin Smith, MD, MBA, discusses the future of regenerative aesthetics and her exosome-based skin care and hair care brand, Exoceuticals.

The Future of Exoceuticals and Innovative Aesthetics, According to Robin Smith, MD, MBA 

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

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Clinical

This episode highlights findings from an investigative study exploring the molecular targeting of biologics for psoriasis, as well as discusses the interleukin(IL)-17 class of biologics, how this class compares to other classes such as IL-23 and TNFα, and how bimekizumab (UCB) sets itself apart from other biologics in the pipeline for psoriasis.

This episode highlights findings from an investigative study exploring the molecular targeting of biologics for psoriasis, the IL-17 drug class, how bimekizumab is different, plus more.

The Cutaneous Connection: Episode 31- Molecular Targeting of Psoriasis Biologics

Mark Lebwohl, MD, takes a deep dive in the recent delay in approval for multiple JAK inhibitor drugs for treatment of inflammatory skin conditions such as psoriasis and atopic dermatitis. He also discusses the impact of the delay, as well as the benefits of JAK inhibitors for inflammatory skin diseases, and an outlook for the future of this drug class.

The Cutaneous Connection: Episode 30- Impact of the JAK Inhibitor Approval Delays

A new paper highlights Alphyn Biologics' Zabalafin Hydrogel as a promising multi-target therapy for atopic dermatitis, addressing inflammation, itch, and bacterial complications.

New Research Highlights Zabalafin Hydrogel's Novel Multi-Targeted Approach to AD Treatment

Quoin Pharmaceuticals advances QRX003 for Netherton Syndrome, receiving FDA's RPD Designation and showing promising clinical results.

FDA Grants Rare Pediatric Disease Designation to QRX003 for Netherton Syndrome 

Nektar Therapeutics reveals positive results from the REZOLVE-AD study, showcasing rezpegaldesleukin's efficacy in treating moderate to severe AD.

REZOLVE-AD Trial Results Show Promise for Rezpegaldesleukin in Atopic Dermatitis 

Galderma launches clinical trials for nemolizumab, targeting systemic sclerosis and chronic pruritus of unknown origin, addressing critical patient needs.

Galderma Announces Clinical Trials Evaluating Nemolizumab for SSc and CPUO

The new PDUFA date is set for September 2025. 

Update: FDA Extends Review of Ruxolitinib Cream for Pediatric AD

Pediatric dermatologist Mercedes E. Gonzalez, MD, discusses roflumilast's promise as a safe, non-steroidal treatment for atopic dermatitis in infants.

Shifting the Paradigm in Infant Atopic Dermatitis Treatment with Roflumilast

“When I'm seeing a patient, an infant with atopic dermatitis [AD], I'd much prefer to have a conversation to discuss the [adverse] effect profile of roflumilast than having to discuss the [adverse] effect profile of a topical corticosteroid,” Mercedes E. Gonzalez, MD, told 

Gonzalez, who also serves as faculty at Larkin Community Hospital South Miami and the University of Miami Department of Dermatology in Florida, shared insights from her extensive experience in pediatric dermatology research, 

particularly her involvement in Arcutis Biotherapeutics’ trials evaluating roflumilast

, a nonsteroidal topical treatment for AD.

Gonzalez has previously served as an investigator in both the MUSE and Integument-PED trials, which included children aged 2 to 5 years. Her unique experience with these studies, along with data from trials in adults and children aged 6 to 11 years, has given her confidence in roflumilast’s safety and efficacy profile. She reported that the medication was well tolerated by patients, with low rates of adverse events—primarily mild cases of upper respiratory infections, diarrhea, and vomiting occurring in less than 4% of participants.

As the trial moves to include younger infants, Gonzalez emphasizes her unique ability to guide families based on previous trial outcomes. She notes that roflumilast fills a critical unmet need in pediatric dermatology by offering a safe, nonsteroidal alternative to traditional topical corticosteroids, which often carry concerns about long-term adverse effects, especially in chronic use.

Gonzalez also highlighted the importance of early intervention in AD, which typically presents in infancy. She believes roflumilast could play a significant role in altering the course of the disease and potentially reducing the progression of the atopic march. Confident that enrollment will progress rapidly, she is optimistic about the trial’s timeline and is eager to see the medication eventually approved by the FDA. Ultimately, Gonzalez hopes to provide her young patients with a safer, effective treatment option that supports long-term skin health without the drawbacks of steroids.

“I think that the [number of] subjects needed to complete the trial is very attainable in a very short period of time,” Gonzalez said. “I know my site's already enrolling patients, and we're really looking forward to completing this and getting this in front of the FDA to have this in our hands to be able to prescribe for our patients.”

Videos

Roflumilast, a non-steroidal topical treatment for atopic dermatitis (AD), is being evaluated in clinical trials led by Dr. Mercedes E. Gonzalez. Her experience with pediatric dermatology research, including the MUSE and INTEGUMENT-PED trials, supports roflumilast's safety and efficacy, with minimal adverse events. This treatment addresses a critical need for a safer alternative to topical corticosteroids, especially for infants. Gonzalez emphasizes early intervention in AD to potentially alter disease progression. She is optimistic about trial enrollment and FDA approval, aiming to offer a safer, effective treatment for young patients.

Pediatric dermatologist Mercedes E. Gonzalez, MD, discusses roflumilast's promise as a safe, nonsteroidal treatment for atopic dermatitis in infants.

Shifting the Paradigm in Infant Atopic Dermatitis Treatment With Roflumilast

Mercedes Gonzalez, MD, discusses the promising INTEGUMENT-INFANT trial, exploring a new non-steroidal treatment for infants with atopic dermatitis.

Investigating Roflumilast 0.05% Cream for Infant AD with Mercedes Gonzalez, MD

Mercedes E. Gonzalez, MD, a pediatric dermatologist based in Miami, Florida, and medical director of Pediatric Skin Research, shared insights into Arcutis’ 

 trial, which investigates roflumilast 0.05% cream in infants with atopic dermatitis (AD). As an expert in pediatric dermatology and investigator of the study, Gonzalez highlighted the significance of this study in addressing a critical treatment gap in infants aged 3 to 24 months, a group where AD often first presents and where FDA-approved non-steroidal treatment options remain extremely limited.

According to Gonzalez, the majority of AD cases begin within the first year of life, with up to 90% of patients showing symptoms before the age of 5. Current treatment options for this young population are predominantly limited to topical corticosteroids. The INTEGUMENT-INFANT trial aims to evaluate the safety, efficacy, and tolerability of a non-steroidal roflumilast cream, potentially offering a novel therapeutic pathway for early intervention. This early intervention could not only improve immediate symptom control but may also play a role in preventing the atopic march, which includes the later development of asthma, allergic rhinitis, and food allergies.

Gonzalez contrasted the INTEGUMENT-INFANT study with Arcutis’ earlier MUSE study, which was a pharmacokinetic trial designed to determine appropriate dosing and absorption levels for roflumilast in younger populations. Findings from MUSE helped establish the 0.05% concentration used in the current trial. She emphasized that a key advantage of the INTEGUMENT-INFANT trial is its family-friendly design. It requires no blood draws and does not include a placebo group, so all enrolled patients receive active treatment. While some families may initially hesitate to enroll their infants in a clinical trial, many are ultimately motivated by the opportunity to contribute to the development of safer, more effective therapies for pediatric AD.

“There's a large unmet need for non-steroid topical treatments in this population. So that's where roflumilast 0.05% cream would fit in very nicely as something that can not only treat the signs and symptoms of eczema in young infants, but also perhaps induce barrier repair, prolonged remissions, and adequate disease control. We're very much looking forward to it,” Gonzalez said.

The INTEGUMENT-INFANT trial, led by Dr. Mercedes E. Gonzalez, explores the use of roflumilast 0.05% cream for infants with atopic dermatitis (AD), addressing a significant treatment gap for those aged 3 to 24 months. Current treatments for this age group are mainly limited to topical corticosteroids. The trial aims to assess the safety, efficacy, and tolerability of this non-steroidal cream, potentially offering a new therapeutic option. The study's design is family-friendly, with no blood draws or placebo group, ensuring all participants receive active treatment.

Investigating Roflumilast 0.05% Cream for Infant AD with Mercedes E. Gonzalez, MD

“This is the first time that a selective ITK inhibitor has been studied in atopic dermatitis or any human immune-mediated disease for that matter. I think this trial is a real step forward in giving us a potential new way to selectively target TH2 and TH17 with an oral medication with an acceptable safety profile,” said Albert Chiou, MD, MBA, in an interview with 

Chiou, a board-certified dermatologist and clinical associate professor of dermatology at the Stanford University School of Medicine in California, is an active investigator in the phase 1 (

) development of soquelitinib (Corvus Pharmaceuticals) for the treatment of patients with moderate to severe atopic dermatitis (AD) who have failed one prior topical or systemic therapy.

Soquelitinib is an investigational, small molecule oral therapeutic designed to selectively inhibit IL-2-inducible T cell kinase (ITK), an enzyme predominantly expressed in T cells and involved in T cell and natural killer (NK) cell immune function.

Albert Chiou, MD, MBA, discusses early clinical data on soquelitinib for atopic dermatitis, highlighting its targeted ITK inhibition, dose-dependent efficacy, favorable safety profile, and more.

Expert Insights Highlight Novel ITK Inhibition With Soquelitinib for AD

Corvus Pharmaceuticals announced new interim data

 for its randomized, double-blind, placebo-controlled phase 1 clinical trial evaluating soquelitinib. The newest data demonstrated a favorable safety and efficacy profile, including earlier and deeper response in patients who received soquelitinib 200 mg twice daily (cohort 3), compared with patients who received soquelitinib 100 mg twice daily (cohort 1) and 200 mg once daily (cohort 2).

Chiou first discussed soquelitinib as a selective covalent inhibitor of ITK. ITK is selectively expressed in T cells, NK cells, and ILC2s (type 2 innate lymphoid cells), making it a specific target for modulating immune responses without broadly suppressing immune function.

Soquelitinib's mechanism blocks TH2 and TH17 pathways—both central to AD pathogenesis—while sparing TH1 responses, which are important for immune defense. Early mechanistic data also suggest that ITK inhibition may promote a shift from TH17 to regulatory T cells, potentially contributing to longer-term disease control.

Of particular interest to Chiou, cohort 3 of the trial received double the daily dose of soquelitinib compared to prior cohorts. Despite enrolling patients with more severe baseline disease (higher EASI scores), this group demonstrated the most robust clinical response, including earlier and deeper reductions in EASI scores. According to Chiou, these results support a dose-dependent pharmacodynamic effect, likely due to greater ITK target engagement. Such dosing could be valuable for patients with more refractory or severe AD.

The safety profile of soquelitinib was favorable in phase 1. Among 48 patients evaluated, the frequency and nature of adverse events were similar between active and placebo arms, all minor in severity. Importantly, no significant laboratory abnormalities or treatment discontinuations were reported.

Efficacy results were also compelling. As Chiou noted, at day 28, up to 63% of patients in the high-dose cohort achieved EASI 75, with some reaching EASI 90. Notably, no placebo patients met these end points, and improvements emerged rapidly within the brief treatment window, highlighting both the speed and magnitude of response.

This represents the first clinical application of an ITK inhibitor in a human immune-mediated condition. According to Chiou, the implications extend beyond AD, given the shared TH2/TH17 involvement across several dermatologic diseases. Soquelitinib may represent a novel, targeted oral therapeutic platform with broad utility in dermatology.

Safety, tolerability, and preliminary efficacy of soquelitinib in participants with moderate to severe AD. Stanford Medicine – Clinical Trials. Accessed May 19, 2025. 

https://clinicaltrials.stanford.edu/trials/s/NCT06345404.html

Corvus Pharmaceuticals announces data from cohorts 1-3 of placebo-controlled phase 1 clinical trial of soquelitinib for atopic dermatitis. Corvus Pharmaceuticals. News release. May 8, 2025. Accessed May 19, 2025. 

https://investor.corvuspharma.com/news-releases/news-release-details/corvus-pharmaceuticals-announces-data-cohorts-1-3-placebo

At the 2025 Society for Investigative Dermatology (SID) Annual Meeting in San Diego, California

, Artax Biopharma presented late-breaking data from their phase 2a study of AX-158, a first-in-class oral Nck modulator targeting T cell-driven inflammation. Scott Batty, MD, Artax’s Chief Medical Officer, and Chris VanDeusen, PhD, Artax’s Chief Scientific Officer, met with Dermatology Times and shared insights into the promising results from this proof-of-mechanism study in patients with mild to moderate plaque psoriasis.

Scott Batty, MD, and Chris VanDeusen, PhD, provided insights on AX-158's phase 2a results, presented at the SID Annual Meeting.

Artax Biopharma's AX-158: A Novel Approach to T Cell-Driven Inflammation in Psoriasis

AX-158 represents a new approach in autoimmune disease management by modulating T cell receptor signaling through the Nck protein, rather than targeting specific cytokines. The 4-week study demonstrated histological improvements in psoriatic lesions, with compelling evidence of AX-158 activity in skin-infiltrating T cells. This provided the first clinical confirmation that the drug engages its intended mechanism in humans. Unlike traditional biologics that target specific immune pathways, Nck modulators allow for suppression of autoimmune pathology while preserving protective immune responses, addressing a key limitation in current therapies.

“We're trying to get the best of both,” VanDeusen said, “We're trying to downregulate the autoimmune responses broadly across all T cells, but at the same time, still allow those necessary and wanted defenses against pathogenic signaling like from viruses and bacteria.”

In terms of safety and efficacy, AX-158 maintained a favorable profile consistent with earlier phase 1 results. Efficacy endpoints were comparable to other early-stage therapies at the same time point. The oral option could deliver steroid-like effectiveness without the associated systemic adverse events, benefiting a wider range of patients who do not adequately respond to existing treatments.

“I think just broadly speaking, our vision for this drug, and given its breadth of applicability of the mechanism, is to really have a once-a-day oral drug with prednisone-like efficacy and none of the safety or long-term sequela effects of chronic use,” Batty said.

Looking ahead, Artax plans to expand AX-158’s development into additional dermatologic indications, with a 12-week phase 2 trial in atopic dermatitis next in line. Further studies in alopecia and vitiligo are also being considered. The company is also investing in extended toxicology programs to enable longer-duration trials, with the goal of progressing into phase 2b and phase 3 development stages.

Artax Biopharma presented promising phase 2a data on AX-158, an oral Nck modulator, at the 2025 SID Annual Meeting. AX-158 targets T cell-driven inflammation in autoimmune diseases like plaque psoriasis by modulating T cell receptor signaling through the Nck protein, offering a novel approach compared to traditional cytokine-targeting biologics. The study showed histological improvements and confirmed the drug's mechanism in humans. AX-158 demonstrated a favorable safety and efficacy profile, with potential for broader dermatologic applications, including atopic dermatitis, alopecia, and vitiligo, in future trials.

“We have benzoyl peroxide products that are forming benzene, some of them at levels above the conditional limit and are not lasting to the point of the expiration date on the product. This is a regulatory problem. These products are not in line with the FDA regulatory standard, and this is an opportunity for innovation in dermatology,” said Christopher Bunick, MD, PhD, in an interview at the 2025 

American Academy of Dermatology (AAD) Annual Meeting

Bunick, associate professor of dermatology and translational biomedicine at Yale School of Medicine in New Haven, Connecticut, and 

’ Editor in Chief, presented “Benzene in Benzoyl Peroxide Treatment in Acne & Rosacea” at the annual meeting.

As one of the researchers who has evaluated benzene concerns in benzoyl peroxide products since the 

 Bunick emphasized the need for practical approaches to benzoyl peroxide use as clinicians and patients await regulatory action.

Addressing Benzoyl Peroxide and Benzene Concerns at AAD 2025 

Benzoyl peroxide is a well-established treatment for acne, however, 

 found that one-third of room temperature tested products exceeded the FDA’s conditional benzene limit of 2 parts per million.

 The FDA only permits this level when essential for a significant therapeutic advance, which does not necessarily apply to benzoyl peroxide given the availability of alternative acne treatments, according to Bunick.

He also highlighted that benzoyl peroxide products undergo stability testing, including accelerated stability testing, to ensure compliance with expiration dates. However, at elevated temperatures, certain formulations degraded into benzene at levels exceeding regulatory limits, indicating potential non-compliance with FDA expiration date standards.

Bunick emphasized that this issue presents an opportunity for innovation in dermatology, particularly in developing more stable formulations of benzoyl peroxide. In his talk, he shared practical steps for clinicians, including findings that refrigerating encapsulated benzoyl peroxide products reduced benzene formation. Based on this, he advises patients to store benzoyl peroxide products in the refrigerator rather than exposing them to heat, such as in cars or warm home environments.

During the annual AAD meeting, L’Oréal announced on March 10 that it is r

ecalling all lots of its benzoyl peroxide-containing Effaclar Duo products

 in the US, sold under the La Roche-Posay brand name, due to benzene concerns.

“We have just heard that some benzoyl peroxide-containing products have been recalled from the market. What does this mean? This simply means that companies are doing their due diligence to try to protect the public patients, as they should,” Bunick told 

Regarding the L’Oréal recall, Bunick’s key message to clinicians is that recalls stem from findings that benzoyl peroxide can degrade into benzene, a known carcinogen. While the full extent of health risks remains unclear and no direct causative link has been established, the recalls highlight a need for greater formulation stability in benzoyl peroxide products.

As the dermatology community awaits further FDA guidance, Bunick reiterated the importance of addressing these regulatory gaps to ensure benzoyl peroxide formulations remain both safe and effective for long-term clinical use.

Valisure detects benzene in benzoyl peroxide. News release. Valisure. March 6, 2024. Accessed March 11, 2025. 

https://www.valisure.com/valisure-newsroom/valisure-detects-benzene-in-benzoyl-peroxide

Kucera K, Zenzola N, Hudspeth A, et al. Evaluation of benzene presence and formation in benzoyl peroxide drug products. J Invest Dermatol. 2024 Oct 7. 

Christopher Bunick, MD, PhD, discussed how to interpret recent benzene research as clinicians await regulatory guidance for benzoyl peroxide. 

Addressing Ongoing Benzoyl Peroxide and Benzene Updates at AAD 2025 

L’Oréal announced today it is recalling all lots of its acne treatment

 Effaclar Duo in the US due to concerns over benzene contamination.

 The product, sold under the La Roche-Posay brand, contains benzoyl peroxide (BPO).

Christopher Bunick, MD, PhD, associate professor of dermatology and physician-scientist at Yale School of Medicine in New Haven, Connecticut, and editor in chief of 

, discussed the news just announced today live at the 2025 American Academy of Dermatology Annual Meeting

Bunick’s key message to clinicians is that recalls stem from findings that benzoyl peroxide can degrade into benzene, a known carcinogen. While the full extent of health risks remains unclear and no direct causative link has been established, the recalls highlight a need for greater formulation stability in benzoyl peroxide products.

Expert Insights Into L'Oréal’s Voluntary Recall of Benzoyl Peroxide Products  

Patient Safety First: Companies are acting responsibly by recalling affected products while further research is conducted.

Stability Concerns: The degradation of benzoyl peroxide into benzene demonstrates the need for improved formulations.

Ongoing Research: More data is needed to determine the true health impact of benzene exposure from these products.

For now, reassure patients that these recalls do not indicate an immediate health crisis but rather a precautionary step. Encourage alternative acne treatments as needed while clinicians await further guidance.

L’Oréal has initiated a recall of its Effaclar Duo acne treatment in the US due to potential benzene contamination. This product, under the La Roche-Posay brand, contains benzoyl peroxide, which may degrade into benzene, a carcinogen. Although the health risks are not fully understood and no direct causative link has been established, the recall underscores the necessity for more stable benzoyl peroxide formulations. Clinicians are advised to reassure patients that this is a precautionary measure and to consider alternative acne treatments while awaiting further research outcomes.

Christopher Bunick, MD, PhD, explains what comes next for clinicians and patients live at AAD 2025.

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