Dermatology Times September 2025 Recap

Clearances, Approvals, Updates, and Recommendations

Biofrontera Completes Ameluz Phase 2b Trial for Moderate to Severe Acne

Biofrontera Inc. advances acne treatment with aminolevulinic acid hydrochloride gel, completing a phase 2b study for moderate to severe cases.

Replimune Prepares for Type A Meeting With FDA on RP1

The FDA cited concerns about patient population heterogeneity and confirmatory trial design.

Arcutis Submits sNDA for Roflumilast Cream 0.3% to Treat Plaque Psoriasis in Patients as Young as 2

Arcutis Biotherapeutics seeks FDA approval for Zoryve cream to treat plaque psoriasis in children as young as 2, addressing a critical treatment gap.

Medicus Moves Forward in UAE Trial for Novel, Non-Invasive BCC Therapy

Medicus Pharma has initiated a phase 2 trial in the UAE for a non-invasive BCC treatment, aiming to revolutionize skin cancer care.

Delgocitinib Now Available in the US for CHE

LEO Pharma's delgocitinib cream for chronic hand eczema is now available to prescribe in the US.

FDA Clears Dermalogica's PRO Pen Microneedling System as a Class II Medical Device

Dermalogica's PRO Pen Microneedling System gains FDA clearance, revolutionizing non-invasive skin treatments with advanced technology and customizable options.

Obagi Medical Expands Into Fillers Following FDA Approval

The new product expands Obagi Medical’s portfolio beyond skin care into injectables.

ICYMI: DermaRite Recall Due to Sepsis Risk Expands to Creams, Hair Products

The expanded voluntary recall is due to the potential microbial contamination of Burkholderiacepacia complex.

Johnson & Johnson Seeks EMA Approval for Oral IL-23 Antagonist Icotrokinra

Phase 3 trials demonstrated that icotrokinra met all primary and co-primary endpoints, including PASI 90 and IGA 0/1 responses.

Krystal Biotech's B-VEC for Dystrophic Epidermolysis Bullosa Gets Expanded FDA Label

Krystal Biotech enhances B-VEC's label, empowering DEB patients with at-home treatment options and improving quality of life through innovative gene therapy.

FDA Approval Brings New Nonsteroidal Option for Pediatric AD

Ruxolitinib cream has become the first topical JAK inhibitor available for pediatric atopic dermatitis (AD) in the US.

FDA Approves Guselkumab for Pediatric Plaque Psoriasis and Psoriatic Arthritis

Phase 3 PROTOSTAR data support new indications, expanding treatment options for children impacted by chronic immune-mediated diseases.

Big Studies and Big Data

Selective JAK Inhibition With Deuruxolitinib Restores Hair Growth in Alopecia Areata

Vimal Prajapati, MD, FRCPC, DABD, reviews the mechanism of action, clinical trial outcomes, monitoring considerations, and safety profile of recently available deuruxolitinib.

How the COVID-19 Pandemic Disrupted Melanoma Diagnosis and Treatment

COVID-19 significantly delayed melanoma diagnoses and treatments, leading to increased disease severity and advanced cases, highlighting urgent health care needs.

CAGE Bio Reports Strong Phase 2b Results for CGB-500 in AD

The study found that 59% of patients achieved IGA treatment success, surpassing other topical therapies.

ASCEND Trial Reports Long-Term Safety of Amgen’s Rocatinlimab in Atopic Dermatitis Patients

Phase 3 topline results reveal rocatinlimab's promising safety and efficacy for moderate to severe AD, targeting the OX40 receptor.

Understanding Family Planning Concerns in Patients with Psoriasis

New insights reveal psoriasis patients' challenges with family planning and pregnancy, highlighting the need for better information and support from healthcare providers.

Sanofi's OX40L Inhibitor Amlitelimab Shows Positive Results in Phase 3 AD Trial

Amlitelimab shows promising phase 3 results in treating atopic dermatitis, achieving significant skin clearance and potential for infrequent dosing.

Biofrontera Completes Enrollment and Active Treatment Phase in Phase 3 Ameluz PDT Trial for AK on the Body

Biofrontera advances closer to expanding the Ameluz PDT label, as phase 3 follow-up data on actinic keratoses are expected next year.

Market, Pharma, and Specialty News

Almirall and Absci Expand Collaboration to Accelerate AI-Powered Drug Discovery for Skin Diseases

Almirall and Absci enhance their collaboration, leveraging AI to revolutionize drug discovery for challenging dermatological conditions and improve patient outcomes.

Allergan's New Campaign and Data Report Fights Misinformation on Hyaluronic Acid Fillers

Allergan Aesthetics has launched an initiative to educate on HA fillers, emphasizing safety and natural results, backed by expert insights and patient satisfaction data.

Cigna Expands Coverage for Home Phototherapy

Cigna’s removal of restrictions on home phototherapy, following a similar decision by Elevance Health, expands access to more than 66 million Americans.

BMS Expands Patient Options With Direct-to-Patient Platform

Bristol Myers Squibb expands direct-to-patient pricing for deucravacitinib and apixaban, enhancing access and affordability for patients in need.

Strides for Skin Health Equity

HS TRUTHS Spotlights Hidden Patient Realities

Research shows it can take 7 to 10 years for individuals with HS to receive an accurate diagnosis.

French Survey Highlights Gaps in Chronic Hand Eczema Care

Most physicians continue to prescribe topical corticosteroids despite prior treatment failure.

Beyond Voluntourism: A Sustainable Approach to Global Medical Missions

Explore how dermatology-focused global medical missions can move beyond short-term “voluntourism” by fostering sustainable, collaborative partnerships that prioritize education, capacity building, and alignment with host country needs.

Science of Skin & Scalp Studio Highlights Cultural Gaps in Dermatology

Dermatologists and hairstylists unite to address scalp health, cultural practices, and patient care at the Science of Skin & Scalp Studio event.

Apex Skin Expands Access and Representation in Dermatology Research

Jorge Garcia-Zuazaga, MD, MBA, FAAD, FACMS, shares how Apex Skin’s multi-site model advances clinical trial access, diversity, and execution.

Closing the Gap: Why Rural Dermatology Access Must Be a Priority

Rural patients face critical delays in dermatology care, highlighting the urgent need for expanded access and support for NPs and PAs in underserved areas.

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