Dermatology Times May 2025 Recap

Clearances, Approvals, Updates, and Recommendations

FDA Approves Sun Pharma's New LED BLU-U Device for AK

Sun Pharma's innovative BLU-U device gains FDA approval, revolutionizing actinic keratosis treatment with advanced blue light therapy.

FDA Approves Arcutis’ Roflumilast Foam for Plaque Psoriasis

FDA approves Arcutis' roflumilast foam, a groundbreaking treatment for plaque psoriasis, offering a steroid-free, effective solution for patients aged 12 and older.

ICYMI: FDA Grants Adalimumab-aaty Interchangeability Designation

Celltrion's Yuflyma gains full FDA interchangeability, enhancing patient access and affordability for various inflammatory conditions.

Big Studies and Big Data

Upadacitinib Shows Promise in Reducing Cardiovascular and Thrombotic Risks in Atopic Dermatitis Patients

Researchers reported that upadacitinib may lower the incidence of major cardiovascular events and venous thromboembolism in AD.

Phase 3 Trial Confirms Roflumilast’s Dual-Site Efficacy

Roflumilast foam shows significant efficacy in treating scalp and body psoriasis, enhancing patient adherence and quality of life in a recent clinical trial.

Corvus Pharmaceuticals’ Soquelitinib Shows Rapid, Dose-Dependent Efficacy in Phase 1 AD Trial

Selective ITK inhibition with oral soquelitinib led to early and durable clinical responses, cytokine reduction, and increased T regulatory cells.

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

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

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

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

Quoin Announces Positive QRX003 Data for Pediatric Peeling Skin Syndrome

A pediatric patient with Peeling Skin Syndrome observed overall skin healing with no adverse events after 12 weeks of treatment.

DecisionDx-Melanoma Test Outperforms Staging and CP-GEP in Identifying Patients Unlikely to Benefit from Sentinel Lymph Node Biopsy

New findings reveal DecisionDx-Melanoma more accurately identifies patients with under 5% risk of SLN positivity, supporting safer avoidance of SLNB surgery.

Psoriasis and Cellulitis Burden Has Increased in the US, According to New Posters

Recent posters at SID revealed significant increases in psoriasis and cellulitis cases in the US, highlighting urgent needs for prevention and treatment strategies.

AC-201 Shows Strong Phase 2 Results in Psoriasis Trial

Accropeutics reveals promising Phase 2 trial results for AC-201, a selective TYK2/JAK1 inhibitor, showing significant efficacy in treating plaque psoriasis.

Market, Pharma, and Specialty News

MJH Life Sciences Expands Beauty and Aesthetics Scope With NewBeauty

MJH Life Sciences acquires NewBeauty, merging clinical expertise with consumer-driven wellness to redefine beauty and aesthetics media.

FDA Launches Agency-Wide AI Rollout by 2025

FDA accelerates AI integration by 2025, enhancing scientific reviews and modernizing regulatory processes for improved public health outcomes.

Clinuvel Completes Enrollment in Phase III Afamelanotide Vitiligo Trial

Clinuvel's phase III trial CUV105 enrolls 200 patients, exploring afamelanotide as a promising systemic treatment for vitiligo.

AbbVie and ADARx Join Forces to Advance Next-Generation siRNA Therapies

The new partnership brings RNA-targeted innovation to dermatology-relevant disease areas like autoimmunity and cancer.

Recludix Unveils First BTK SH2 Domain Inhibitor

Recludix Pharma unveils a groundbreaking BTK SH2 inhibitor, showcasing superior selectivity and efficacy for chronic spontaneous urticaria treatment at SID 2025.

Lurie Children’s Becomes First Treatment Center for Zevaskyn Gene Therapy in Patients with RDEB

ZEVASKYN, the first FDA-approved gene therapy for wounds in recessive dystrophic epidermolysis bullosa, is now available at Lurie Children's Hospital.

Shaant ClearSkin Probiotic Granted Patent for Acne Relief

Discover how Shaant ClearSkin Probiotic offers a holistic approach to acne treatment by targeting gut health and hormonal balance for clearer skin.

Triveni Bio Launches First-in-Human Trial for TRIV-509 in Atopic Dermatitis

Triveni Bio initiates a phase 1 trial for TRIV-509, a promising treatment for atopic dermatitis, targeting key inflammatory pathways.

Ascletis Receives FDA Clearance to Advance ASC50, a Novel Oral IL-17 Inhibitor, Into Phase 1 Psoriasis Trial

Ascletis Pharma's investigational new drug application for ASC50 gains FDA clearance for a phase 1 trial for mild to moderate psoriasis.

Quoin Receives FDA Clearance for Second Netherton Trial

Quoin Pharmaceuticals advances QRX003 for Netherton Syndrome, receiving FDA clearance for a pivotal trial to assess its effectiveness and safety.

Dermalyser Secures CE Mark in Europe for AI-Powered Melanoma Detection Tool

AI Medical Technology launches Dermalyser, an AI tool for melanoma diagnosis, enhancing detection accuracy and skin cancer care in Europe.

New DEBRA-Dermaliq Collaboration Targets Enhanced Drug Delivery for Epidermolysis Bullosa

A new partnership aims to revolutionize topical treatments for epidermolysis bullosa, enhancing patient care with innovative drug delivery technology.

Strides for Skin Health Equity

Building Trust Through Cultural Competency in Aesthetic Dermatology

Explore how cultural competency in aesthetic dermatology bridges trust gaps, ensuring inclusive care for patients of color and enhancing treatment outcomes.

AAD Partners With SOCS to Launch Inclusive Image Library

The Clinical Image Collection enhances dermatologic education by providing diverse images of skin conditions, promoting inclusivity and accurate diagnoses across all skin tones.

Missed Diagnoses, Missed Opportunities: Closing the Gap in Skin Cancer for Patients of Color

Explore the urgent need for improved skin cancer awareness and care for minority populations, addressing disparities in diagnosis and treatment.

Uncovering Inequities in Hidradenitis Suppurativa Trials

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

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

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

Psoriasis Linked to Sleep Disorders in Diverse Adults

Psoriasis significantly impacts sleep health, with diverse populations facing increased risks of sleep disorders, highlighting urgent clinical needs for tailored interventions.

Depression Risks in Patients With Vitiligo Vary Significantly by Race and Ethnicity

New research reveals significant racial disparities in depression risk among vitiligo patients, highlighting the need for culturally sensitive mental health support.

Don’t miss a moment of Dermatology Times by signing up for our eNewsletters and subscribing to receive the free print issue and supplements each month.