Enstilar (calcipotriene/betamethasone dipropionate) / LEO Pharma - LARVOL DELTA

A Psoriasis Plaque Test Trial With LP0113 Spray in Patients With Psoriasis Vulgaris (LP0113-1123) (clinicaltrials.gov) - P2 | N=50 | Completed | Sponsor: LEO Pharma | Phase classification: P2a ➔ P2

Phase classification • Dermatology • Immunology • Psoriasis • Rheumatology

Anti-tumor necrosis factor-alpha inhibitor-induced linear psoriasis: A case report. (PubMed, SAGE Open Med Case Rep) - "A clinical diagnosis of linear psoriasis was made, and the patient's dosage interval of infliximab was decreased to every 6 weeks. This case illustrates the potential for Betamethasone diproprionate/calcipotriol (Enstilar) topical foam use as a treatment approach for anti-tumor necrosis factor-alpha inhibitor-induced linear psoriasis. At present there is no consensus on linear psoriasis pathogenesis or best treatment approach, therefore, more research is needed to understand its pathogenesis and establish management guidelines."

Journal • Dermatology • Hidradenitis Suppurativa • Immunology • Oncology • Psoriasis

Fixed-dose combination of calcipotriene/betamethasone dipropionate foam for the management of mild-to-moderate psoriasis in daily clinical practice: a collection of clinical experiences. (PubMed, Drugs Context) - "A group of experts discussed the value of the Cal/BD foam as a topical treatment for mild-to-moderate psoriasis in combination with systemic treatments. The reported experiences support effectiveness of the Cal/BD foam in daily clinical practice, with an improvement in patient quality of life."

Journal • Dermatology • Immunology • Psoriasis

Aggressive mycosis fungoides with large cell transformation and cerebral involvement (ADO 2024) - "The patient had previously been treated externally for psoriasis vulgaris with calcipotriol/betamethasone foam...The therapy was then switched to mogamulizumab (4 cycles), which resulted in further progression. Chemotherapy with gemcitabine was initiated to quickly reduce the tumor burden...This case shows that a manifestation of the CNS should be considered, especially in the case of large cell transformation and neurological symptoms. In addition to a radiological examination, a lumbar puncture should also be performed in order to initiate CNS-targeted therapy at an early stage."

CNS Disorders • Cutaneous T-cell Lymphoma • Dermatology • Dermatopathology • Gastroenterology • Gastrointestinal Disorder • Immunology • Mycosis Fungoides • Oncology • Peptic Ulcer • Pruritus • Psoriasis • Rheumatology

Drugs for plaque psoriasis. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Review • Dermatology • Immunology • Psoriasis

Comparison table: Some drugs for plaque psoriasis. (PubMed, Med Lett Drugs Ther) - No abstract available

Clinical • Journal • Dermatology • Immunology • Psoriasis

Psoriasis during natalizumab treatment for multiple sclerosis (EADV 2024) - "The patient was initiated on daily calcipotriene and betamethasone dipropionate foam, resulting in excellent clinical response. The association between natalizumab and psoriasis has been increasingly recognized in recent years. Natalizumab acts by inhibiting the migration of immune cells, particularly T cells, into the central nervous system, thereby reducing inflammation in multiple sclerosis. However, this mechanism of action may also lead to dysregulation of immune responses in the skin, predisposing patients to the development of psoriasis or exacerbation of pre-existing disease."

CNS Disorders • Dermatology • Dermatopathology • Immunology • Inflammation • Multiple Sclerosis • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Pain • Psoriasis

Effectiveness and safety of deucravacitinib combined with calcipotriene/betamethasone dipropionate for treating moderate to severe plaque psoriasis (EADV 2024) - "Enstilar (calcipotriene 0.005%/betamethasone dipropionate 0.064%; C/BD) , a topical foam, is also approved to treat plaque psoriasis. Adding daily tapinarof cream to an existing biologic was tolerable and helped patients achieve the NPF treatment goal. This approach may prevent the need for switching biologics when patients do not respond, preserving the safety and cost associated with their current biologic."

Clinical • Dermatology • Immunology • Psoriasis • TYK2

Tumor necrosis factor-alpha inhibitor-associated psoriatic alopecia and palmoplantar pustulosis in a patient with ulcerative colitis (EADV 2024) - "We report a 29 - year - old woman who developed TiAPA and palmoplantar pustulosis after 6 months of treatment with infliximab for ulcerative colitis. Patient was switched out of class to ustekinumab after discontinuation of infliximab. Treatment was escalated with the addition of UVB phototherapy and topical therapy (calcipotriol/betamethasone dipropionate foam, emollient and keratolytic agent – urea) ."

Clinical • Alopecia • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Arthritis • Inflammatory Bowel Disease • Oncology • Psoriasis • Rheumatoid Arthritis • Rheumatology • Ulcerative Colitis

LEO Pharma Submits New Drug Application for Enstilar for Adults with Plaque Psoriasis in China (Businesswire) - "LEO Pharma A/S, a global leader in medical dermatology, has today announced its submission of a New Drug Application (NDA) to the National Medical Products Administration (NMPA) for Enstilar (LEO 90100) to treat adult patients living with plaque psoriasis....The NDA submission is supported by results from a phase 3 trial comparing the efficacy and safety of a once daily application with Enstilar and Daivobet ointment after 4 weeks of treatment in adult Chinese subjects with stable plaque psoriasis (N=604)....Following the Enstilar submission, the Centre for Drug Evaluation (CDE) will validate the filing, before the full evaluation of the NDA is conducted by the CDE. The regulatory review process is expected to conclude in the first half of 2026."

China filing • Psoriasis

A Psoriasis Plaque Test Trial With LEO 90100 Compared to Betesil® in Patients With Psoriasis Vulgaris (clinicaltrials.gov) - P2 | N=35 | Completed | Sponsor: LEO Pharma | Phase classification: P2a ➔ P2

Phase classification • Dermatology • Immunology • Psoriasis • Rheumatology

Case Report of Patient with Eosinophilic Annular Erythema secondary to Rheumatological Disorder (EADV-Sp 2024) - "He received an initial diagnosis of psoriasis and received treatment in the form of Dobovet and Enstilar... EAE is a rare condition in which you can get these changes including lots of eosinophils in the skin biopsy. EAE is also associated with rheumatological disorders. This clinical picture adds up given his recent diagnosis and treatment of Polymyalgia Rheumatica."

Case report • Clinical • Dermatitis • Dermatology • Dermatopathology • Eosinophilia • Giant Cell Arteritis • Hematological Disorders • Musculoskeletal Pain • Pain • Pruritus • Psoriasis • Rheumatology

A narrative review of fixed combination calcipotriol/betamethasone aerosol foam (Enstilar®) in the management of psoriasis with scalp involvement. (PubMed, Drugs Context) - "The findings from these studies show that Cal/BD aerosol foam is rapidly effective, improves skin condition, alleviates symptoms such as itch, and has a positive impact on patient quality of life. These attributes address several unmet needs for patients with psoriasis with scalp involvement and have the potential to improve individual adherence to treatment."

Journal • Review • Dermatology • Immunology • Psoriasis

Evaluation of Add on Enstilar in Patients Using Otezla for Psoriasis (clinicaltrials.gov) - P4 | N=50 | Completed | Sponsor: Psoriasis Treatment Center of Central New Jersey | Unknown status ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis

A Study to Investigate Efficacy and Safety With LEO 90100 Compared With Daivobet® Ointment in Adult Chinese Subjects With Stable Plaque Psoriasis (clinicaltrials.gov) - P3 | N=604 | Completed | Sponsor: LEO Pharma | Active, not recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis

Combination of Sotyktu and Enstilar for Plaque Psoriasis (clinicaltrials.gov) - P4 | N=30 | Completed | Sponsor: Psoriasis Treatment Center of Central New Jersey

Combination therapy • New P4 trial • Dermatology • Immunology • Psoriasis

A Study to Investigate Efficacy and Safety With LEO 90100 Compared With Daivobet® Ointment in Adult Chinese Subjects With Stable Plaque Psoriasis (clinicaltrials.gov) - P3 | N=604 | Active, not recruiting | Sponsor: LEO Pharma | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2024 ➔ Mar 2024 | Trial primary completion date: Jun 2024 ➔ Feb 2024

Enrollment closed • Trial completion date • Trial primary completion date • Dermatology • Immunology • Psoriasis

Improvements in Plaque Psoriasis Associated with Calcipotriol/Betamethasone Aerosol Foam Treatment: A Post Hoc Analysis of Non-interventional Studies and Clinical Experience. (PubMed, Dermatol Ther (Heidelb)) - "These results show that regardless of NIS location, Cal/BD foam remains a well-tolerated, efficacious option for patient care that could be used as a first-line topical therapy for mild-to-severe psoriasis."

Clinical • Journal • Observational data • Retrospective data • Dermatology • Immunology • Inflammation • Psoriasis

Matching-adjusted Indirect Comparison of Dermatology Life Quality Index 0/1 Response in Trials of Calcipotriol Plus Betamethasone Dipropionate Foam and Cream Formulations in Patients with Psoriasis. (PubMed, Acta Derm Venereol) - No abstract available

Journal • Dermatology • Immunology • Psoriasis

Calcipotriene/Betamethasone Dipropionate Foam as a Potential Safe and Effective Treatment of Nail Psoriasis. (PubMed, Skin Appendage Disord) - "We conclude this foam combination product could be an effective and safe treatment for fingernail psoriasis and may provide better nail matrix penetration as evidenced by improvement in nail matrix score. Further studies are needed for additional evaluation."

Journal • Dermatology • Immunology • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Residual Disease MEMory in PSOriasis Skin During EnstiLAR® and Narrow-band Ultraviolet B Therapy: The MEMPSOLAR Study (clinicaltrials.gov) - P4 | N=12 | Active, not recruiting | Sponsor: Aarhus University Hospital | Trial primary completion date: Nov 2024 ➔ Jan 2024

Trial primary completion date • Cognitive Disorders • Dermatology • Immunology • Psoriasis • Rheumatology • CD4 • CD69 • CD8 • ITGAE

A focused review on laser- and energy-assisted drug delivery for nail disorders. (PubMed, Lasers Med Sci) - "For psoriatic nails, LADD was used to deliver calcipotriol-betamethasone dipropionate foam, tazarotene, triamcinolone, or methotrexate into the nail. Laser-assisted drug delivery for nail disease is a newer approach for onychomycosis and nail psoriasis with several benefits and drawbacks. Dermatologists should discuss the option of LADD with their patients who have recalcitrant onychomycosis or nail psoriasis."

Journal • Review • Dermatology • Immunology • Infectious Disease • Psoriasis

Calcipotriol/betamethasone dipropionate foam for plaque psoriasis: a prospective, observational, non-interventional quality of life study. (AEDV 2024) - No abstract available

Clinical • HEOR • Observational data • Dermatology • Immunology • Psoriasis

psowyn: Evaluation of Tolerability, Efficacy and Adherence to Treatment With Wynzora Cream (clinicaltrials.gov) - P=N/A | N=30 | Not yet recruiting | Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Adherence • New trial • Dermatology • Immunology • Psoriasis

A Study Evaluating the Efficacy and Tolerability of Enstilar Foam in Patients With Nail Psoriasis (clinicaltrials.gov) - P4 | N=3 | Completed | Sponsor: University of Alabama at Birmingham | Recruiting ➔ Completed | N=20 ➔ 3

Enrollment change • Trial completion • Dermatology • Immunology • Psoriasis • Psoriatic Arthritis