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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: July 16, 2025

Renata Block, DMSc, MMS, PA-C, is a board-certified physician assistant and instructor at Rush University in Chicago, Illinois, a 

 editorial advisory board member, and the past president of the Society of Dermatology Physician Associates (SDPA) and the Illinois SDPA.

With longer visits and flat-rate pricing, Kment’s practice provides personalized dermatologic care to both insured and uninsured patients.

Derm Dispatch: Cutting Costs, Not Care with Jacki Kment, PA-C, MPAS, DFAAPA

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.

A first-of-its-kind study reveals AI-driven insights on hair loss trends, highlighting the impact of genetics, hormones, and COVID-19 on alopecia.

AI-Powered Insights from 1 Million Users Reveal New Trends in Hair Loss

A systematic review reveals significant Treg cell deficiencies in vitiligo, highlighting their role as therapeutic targets for improved treatment strategies.

Review Highlights Treg Cell Impairment as Key Factor in Vitiligo

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

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Renata Block, DMSc, MMS, PA-C, interviews Amy Snow, PA-C, who shares how she transformed career roadblocks into a mobile dermatology clinic delivering free care and hope across Oregon.

Derm Dispatch: Amy Snow, PA-C, on Turning a Non-Compete Setback Into a Mission That Changes Lives

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.

clinical

Video Series

the commencement of a randomized, double-blind, vehicle-controlled clinical trial

 evaluating its topical GX-03 formation for the treatment of moderate to severe atopic dermatitis (AD).

The study, which began patient dosing on July 11 in Dallas, represents the first clinical trial of a topical IL-36 inhibitor. This trial builds upon promising preclinical findings that demonstrated GX-03’s immunological activity in modulating key inflammatory cytokines associated with eczema.

"Patients with moderate to severe eczema often face limited treatment options, from painful or costly injectables to steroids that can cause long-term side effects," said Bradley Burnam, CEO of Turn Therapeutics, in a news release. "Dosing our first patients in this clinical trial is a milestone in our mission to deliver an easy-to-use, safe, topical therapy that improves patients' quality of life."

GX-03, the active formulation previously integrated into Turn’s FDA-cleared wound care product Hexagen, is now under formal investigation as a potential drug treatment. While Hexagen has already achieved clearance for use in acute and chronic wound care, the current trial marks a new direction for Turn Therapeutics as it seeks to expand GX-03’s use into the dermatologic drug space. The company noted it is also pursuing indications for onychomycosis.

The phase 1/2 clinical study aims to enroll 114 patients with moderate to severe AD. The study will span an 8-week treatment duration, during which the primary endpoint will be the change in Eczema Area and Severity Index (EASI) scores from baseline. Secondary endpoints include the Investigator Global Assessment (IGA) and Max-Itch assessments, offering a comprehensive picture of the product’s therapeutic effects on both visible skin symptoms and pruritus-related discomfort.

The mechanism behind GX-03 lies in its ability to inhibit IL-36 alpha and IL-36 gamma—cytokines increasingly recognized for their role in the pathophysiology of inflammatory skin disorders, including eczema and psoriasis. In addition, GX-03 has shown suppressive effects on IL-4 and IL-31, both of which are involved in inflammatory and itch pathways, respectively. The company noted IL-31, in particular, hasemerged as a key target in addressing eczema-related itch, a hallmark symptom that significantly impairs patients' quality of life.

With more than 200,000 human uses and a favorable safety profile established through prior wound care applications, GX-03 is entering this trial with a well-documented background in real-world use. The transition from medical device to drug development highlights a broader industry trend of repurposing known, safe technologies to address unmet clinical needs in dermatology.

"For years, patients like me have been offered outdated, one-size-fits-all treatments that fail to address the root causes of disease," Burnam said in the release. "This trial is designed to deliver proof of concept toward our goal of successfully and safely treating the source of eczema, rather than simply managing its symptoms."

Top-line results from the study are expected by the end of 2025. If successful, GX-03 could emerge as a novel, non-steroidal therapeutic option for patients who require safe, effective alternatives to current systemic or corticosteroid-based therapies.

Turn Therapeutics begins clinical trial of first topical IL-36/IL-31 inhibitor for eczema. News Release. Business Wire. Published July 14, 2025. Accessed July 14, 2025. 

http://businesswire.com/news/home/20250714700228/en/Turn-Therapeutics-Begins-Clinical-Trial-of-First-Topical-IL-36IL-31-Inhibitor-for-Eczema

Turn Therapeutics atopic dermatitis candidate reduces disease severity by 57% in-vivo. News release. BioSpace. June 20, 2024. Accessed July 14, 2025. 

https://www.biospace.com/article/releases/turn-therapeutics-atopic-dermatitis-candidate-reduces-disease-severity-by-57-percent-in-vivo/#:~:text=All%20(816%2C573)-,Turn%20Therapeutics%20Atopic%20Dermatitis%20Candidate,Severity%20by%2057%25%20In%2DVivo&text=LOS%20ANGELES%2D%2D(BUSINESS%20WIRE,in%20disease%20severity%20versus%20placebo

Turn Therapeutics has initiated a clinical trial for GX-03, a topical IL-36 inhibitor, targeting moderate to severe atopic dermatitis. This trial, the first of its kind, follows promising preclinical results and aims to offer a non-steroidal alternative to current treatments. GX-03, previously used in wound care, inhibits cytokines IL-36, IL-4, and IL-31, addressing inflammation and itch. The study will assess changes in Eczema Area and Severity Index scores over eight weeks. Successful results could position GX-03 as a novel therapeutic option by 2025.

Turn Therapeutics initiates a groundbreaking clinical trial for GX-03, the first topical IL-36 inhibitor targeting moderate to severe eczema.

Turn Therapeutics Launches Trial for AD Topical GX-03

The first half of 2025 brought about numerous developments in dermatology, with key decisions from the FDA and a surge of activity across submissions, trial advancements, and regulatory actions driving the pipeline forward. To help you stay informed, we compiled an overview of FDA approvals and clearances, new filings, and other pivotal regulatory movements in the specialty from January through June.

Fesarius Therapeutics Inc was granted 510(k) clearance for its DermiSphere hydrogel Dermal Regeneration Template (DermiSphere hDRT).

The collagen-based dermal matrix is engineered to support tissue integration, revascularization, and wound healing, making it suitable for advanced wound care, reconstructive surgery, and regenerative medicine. The agent features a hydrogel composition that closely mimics the extracellular matrix, enhancing cellular infiltration and tissue regeneration.

Dupilumab for H1 Antihistamine-Refractory CSU

 Dupilumab (Dupixent; Sanofi and Regeneron) received approval for the treatment of chronic spontaneous urticaria (CSU) in patients aged 12 years and older whose symptoms remain uncontrolled with H1 antihistamines.

 This marks the first new targeted CSU therapy for patients in over a decade. In the pivotal phase 3 LIBERTY-CSU CUPID trial (NCT04180488), especially Study C, dupilumab showed significant improvements in symptom control, with nearly half of biologic-naive patients achieving well-controlled disease.

The FDA approved prademagene zamikeracel, also known as pz-cel (Zevaskyn; Abeona Therapeutics Inc), marking the first autologous, gene-corrected cell therapy for recessive dystrophic epidermolysis bullosa.

 The agency based its landmark approval on data from the phase 3 VIITAL trial and a phase 1/2a study, which demonstrated significant and durable wound closure following a single application, with some patients experiencing benefits lasting up to 8 years.

 Sun Pharmaceutical Industries Limited received premarket approval for its next-generation BLU-U Blue Light Photodynamic Therapy Illuminator.

The updated device replaces the original fluorescent tube design with modern LED panels. It is approved for use alongside Levulan Kerastic topical solution, 20%, (aminolevulinic acid HCl) , to treat minimally to moderately thick actinic keratoses on the face, scalp, and upper extremities.

 Arcutis Biotherapeutics’ Zoryve (roflumilast) foam 0.3% was granted approval for the treatment of plaque psoriasis on the scalp and body in patients aged 12 years and older.

 The steroid-free, once-daily foam formulation offers a convenient option for treating hard-to-reach, hair-bearing areas where traditional creams or ointments may be difficult to apply. Clinical trial data showed that roflumilast foam delivered rapid itch relief and significant plaque clearance, with no restrictions on duration of use.

Regeneron and Sanofi's dupilumab (Dupixent) was granted approval as the first targeted treatment for adults with bullous pemphigoid, offering an advancement over traditional therapies like steroids and immunosuppressants.

 Backed by strong phase 2/3 data showing improved remission rates, reduced itch, and lower corticosteroid use, dupilumab demonstrated superior efficacy in real-world and comparative studies.

Zabalafin Hydrogel’s IND Application Cleared for AD

 Alphyn Biologics’ investigational new drug (IND) application for Zabalafin hydrogel received clearance as a novel topical treatment for mild to moderate atopic dermatitis (AD).

 Designed to target inflammation, itch, and bacterial complications, the agent demonstrated promising results in a phase 2a trial. Patients showed notable improvements in symptoms, including itch relief and resolution of skin infections, and the drug had a favorable safety profile.

Rezpegaldesleukin Receives Fast Track Designation for Moderate to Severe AD

Rezpegaldesleukin received a fast track designation for the treatment of moderate to severe AD in patients aged 12 years and older whose condition is not adequately managed with topical therapies.

 Nektar Therapeutics’ investigational biologic works by targeting the IL-2 receptor complex to boost regulatory T-cell function and help restore immune balance. In clinical studies, including a 12-week induction phase with follow-up extending 36 weeks post treatment, rezpegaldesleukin demonstrated encouraging improvements in exploratory disease measures.

FDA Accepts SNDA for Roflumilast in Children with AD

The FDA accepted Arcutis Biotherapeutics’ supplemental new drug application (SNDA) for Zoryve (roflumilast) cream 0.05% to treat mild to moderate AD in children aged 2 to 5 years.

 The submission was backed by positive data from the INTEGUMENT-PED phase 3 trial (NCT04845620), which showed significant symptom improvements by week 4. The agency has set a target action date of October 13, 2025.

Bempikibart Receives Fast Track Designation for Alopecia Areata

Q32 Bio received a fast track designation for its investigational therapy, bempikibart (ADX-914), for the treatment of alopecia areata.

 Bempikibart, a fully human anti–IL-7Rα antibody, works by re-regulating immune function to block IL-7 and TSLP signaling. The fast track status follows encouraging clinical results from the ongoing SIGNAL-AA trial.

Fesarius Therapeutics Inc announces FDA 510(k) clearance for DermiSphere hydrogel Dermal Regeneration Template. News release. FesariusTherapeutics Inc. January 8, 2025. Accessed June 4, 2025. 

https://www.prnewswire.com/news-releases/fesariustherapeutics-inc-announces-fda-510k-clearance-for-dermisphere-hydrogel-dermal-regeneration-template-302346137.html

Dupixent (dupilumab) approved in the US as the first new targeted therapy in over a decade for chronic spontaneous urticaria (CSU). News release. Regeneron Pharmceuticals, Inc. April 18, 2025. Accessed June 4, 2025. 

https://www.globenewswire.com/news-release/2025/04/18/3064133/0/en/Dupixent-dupilumab-Approved-in-the-U-S-as-the-First-New-Targeted-Therapy-in-Over-a-Decade-for-Chronic-Spontaneous-Urticaria-CSU.html

US FDA approves Zevaskyn (prademagene zamikeracel), the first and only cell-based gene therapy for patients with recessive dystrophic epidermolysis bullosa (RDEB). News release. Abeona Therapeutics Inc. April 29, 2025. Accessed June 4, 2025. 

https://investors.abeonatherapeutics.com/press-releases/detail/303/u-s-fda-approves-zevaskyn-prademagene-zamikeracel

Sun Pharma announces FDA approval of next-generation BLU-U Blue Light Photodynamic Therapy Illuminator for actinic keratosis. News release. Sun Pharma. May 16, 2025. Accessed June 4, 2025. 

https://www.prnewswire.com/news-releases/sun-pharma-announces-fda-approval-of-next-generation-blu-u-blue-light-photodynamic-therapy-illuminator-for-actinic-keratosis-302457770.html

Arcutis’ Zoryve (roflumilast) topical foam 0.3% approved by US FDA for the treatment of plaque psoriasis in adults and adolescents ages 12 and older. News release. Arcutis Biotherapeutics Inc. May 22, 2025. Accessed June 4, 2025. 

https://www.arcutis.com/arcutis-zoryve-roflumilast-topical-foam-0-3-approved-by-u-s-fda-for-the-treatment-of-plaque-psoriasis-in-adults-and-adolescents-ages-12-and-older/

Dupixent approved in the US as the only targeted medicine to treat patients with bullous pemphigoid. News release. Sanofi. June 20, 2025. Accessed June 20, 2025. 

https://www.sanofi.com/en/media-room/press-releases/2025/2025-06-20-05-00-00-3102518

Alphyn secures FDA clearance of investigational new drug application for atopic dermatitis treatment. News release. Alphyn Biologics, Inc. February 19, 2025. Accessed June 4, 2025. 

https://www.prnewswire.com/news-releases/alphyn-secures-fda-clearance-of-investigational-new-drug-application-for-atopic-dermatitis-treatment-302379675.html

Nektar Therapeutics receives fast track designation for rezpegaldesleukin for the treatment of moderate-to-severe atopic dermatitis. News release. Nektar Therapeutics. February 10, 2025. Accessed June 4, 2025. 

https://www.prnewswire.com/news-releases/nektar-therapeutics-receives-fast-track-designation-for-rezpegaldesleukin-for-the-treatment-of-moderate-to-severe-atopic-dermatitis-302371995.html

US FDA accepts supplemental new drug application for Arcutis’ Zoryve (roflumilast) cream 0.05% for the treatment of children aged 2 to 5 with mild-to-moderate atopic dermatitis. News release. Arcutis Biotherapeutics, Inc. February 26, 2025. Accessed June 4, 2025. 

https://www.arcutis.com/u-s-fda-accepts-supplemental-new-drug-application-for-arcutis-zoryve-roflumilast-cream-0-05-for-the-treatment-of-children-aged-2-to-5-with-mild-to-moderate-atopic-dermatitis/

Q32 Bio announces FDA Fast Track Designation granted to bempikibart (ADX-914) for the treatment of alopecia areata. PR Newswire. April 30, 2025. Accessed June 4, 2025. 

https://www.prnewswire.com/news-releases/q32-bio-announces-fda-fast-track-designation-granted-to-bempikibart-adx-914-for-the-treatment-of-alopecia-areata-302441850.html

The first half of 2025 saw significant advancements in dermatology, driven by FDA approvals and regulatory actions. Key developments included the clearance of Fesarius Therapeutics' DermiSphere hydrogel for wound care, approval of dupilumab for chronic spontaneous urticaria, and the landmark approval of prademagene zamikeracel for recessive dystrophic epidermolysis bullosa. Sun Pharmaceutical's LED BLU-U device and Arcutis Biotherapeutics' roflumilast foam for plaque psoriasis also received approvals. Additionally, investigational treatments for atopic dermatitis and alopecia areata gained regulatory momentum, highlighting the dynamic progress in dermatological therapeutics.

Exclusive Report: A comprehensive look at the latest FDA approvals and pipeline developments in dermatology from the first half of 2025.

FDA News and Decisions: Midyear Updates

This week is Hidradenitis Suppurativa Awareness Week.

POLL: What is the Most Common Trigger of Hidradenitis Suppurativa?

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?

the US Food and Drug Administration (FDA) published over 200 decision letters

, known as Complete Response Letters (CRLs), in response to applications submitted for approval of drugs or biological products between 2020 and 2024. The agency says this marks a “significant step” in their broader initiatives to modernize and increase overall transparency.

“By making the CRLs available, the public now has significantly greater insight into the FDA’s decision-making and the most common deficiencies cited that sponsors must address before their application is approved,” the FDA said in a news release.

"In the world of drug development, transparency is critical for all parties involved - industry, clinicians, patients, and regulators. The recent publishing of complete response letters from the last 5 years is a bold and surprising move by the FDA, our main regulatory gatekeeper when it comes to the approval of new drugs," clinical associate professor at the Rosalind Franklin University Chicago Medical School, founder and director of the Center for Medical Dermatology and Immunology Research in Chicago, and a 

Editorial Advisory Board member, Raj Chovatiya, MD, PhD, MSCI, FAAD, told 

. One can surmise that the intention of this decision is to provide clarity surrounding drug application decisions that have been made by the FDA in recent years, and I am hopeful that in the long run, open communication of this kind of information will be used to strengthen the relationship between the FDA and drug developers, instill public trust in the regulatory process, and help demystify the world of pharmaceutical regulatory approval.

CRLs are issued when the FDA completes its review cycle and are sent directly to sponsors. They determine that an approval cannot be granted of an application in its current form. Recently in the world of dermatology, the FDA approved dupilumab for adolescents and adults with H1 Antihistamine-refractory chronic spontaneous urticaria (CSU), despite an October 2023 CRL stating that additional efficacy data were needed to support approval. In response to this CRL, Regeneron and Sanofi resubmitted the supplemental Biologics License Application (sBLA) including updated efficacy and safety data from a third phase 3 trial – 

ultimately leading to the long-awaited approval

The FDA can issue CRLs for various reason, most related to safety and efficacy concerns, manufacturing deficiencies, and bioequivalence issues. In the case of dupilumab for CSU, while additional efficacy data was requested the agency did not identify any concerns regarding safety or manufacturing. CRLs detail any deficiencies and may also include recommendations for addressing them.

In another case concerning prademagenezamikeracel (pz-cel) for the treatment of recessive dystrophic epidermolysis bullosa, 

the FDA issued a CRL noting the need for additional chemistry, manufacturing, and controls information

, including validation for specific manufacturing and release testing methods stated during the pre-license inspection. Abeona Therapeutics later resubmitted its BLAforpz-cel, 

The FDA has published over 200 Complete Response Letters (CRLs) from 2020 to 2024, enhancing transparency in its decision-making process. CRLs, issued when an application cannot be approved in its current form, provide insight into common deficiencies such as safety, efficacy, and manufacturing issues. The publication aims to reduce misrepresentation by sponsors and improve industry understanding of non-approvals. Notable cases include the approval of dupilumab for chronic spontaneous urticaria and prademagenezamikeracel for epidermolysis bullosa, following CRLs and subsequent resubmissions with additional data.

FDA enhances transparency by publishing over 200 Complete Response Letters, offering insights into drug approval processes and common deficiencies.

Amy Snow, PA-C

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