Sorilux (calcipotriene foam) / Mayne Pharma - LARVOL DELTA

Intralesional 5-Fluorouracil (5FU), Topical Calcipotriene Treatment for SCC (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Melissa Pugliano-Mauro | Trial completion date: Oct 2025 ➔ Oct 2026 | Trial primary completion date: Sep 2025 ➔ Sep 2026

Trial completion date • Trial primary completion date • Oncology • Squamous Cell Carcinoma

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

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

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

Journal • Dermatology • Immunology • Psoriasis

Matching-Adjusted Indirect Comparison of Long-Term Efficacy and Safety Outcomes for Calcipotriol Plus Betamethasone Dipropionate Foam Versus Halobetasol Proprionate Plus Tazarotene Lotion in the Treatment of Plaque Psoriasis. (PubMed, Dermatol Ther (Heidelb)) - P3 | "Cal/BD aerosol foam demonstrated significantly greater efficacy than HP/Taz lotion, and had a more favorable safety profile, compared with HP/Taz lotion, for up to 52 weeks. Proactive Cal/BD foam maintenance therapy and reactive use of Cal/BD foam following relapse both had significant advantages over HP/Taz lotion."

Journal • Dermatitis • Dermatology • Immunology • Pain • Pruritus • Psoriasis

Calcipotriene/betamethasone dipropionate foam: primary evidence supporting its use in patients with psoriasis vulgaris. A narrative review. (PubMed, Postepy Dermatol Alergol) - "The results of the key randomised clinical studies investigating the efficacy, including patients' quality of life and safety of the foam versus ointment, gel and either active ingredient in foam vehicle are presented. In addition, the results of a study on maintenance treatment with calcipotriene/betamethasone dipropionate foam as well as reports on real-world use of this medicine in patients with psoriasis, are discussed."

Clinical • Journal • Review • Dermatology • Immunology • Psoriasis

Matching-adjusted indirect comparison of efficacy outcomes in trials of calcipotriol plus betamethasone dipropionate foam and cream formulations for the treatment of plaque psoriasis. (PubMed, J Dermatolog Treat) - "Mean reductions in mPASI were consistently statistically significantly greater with Cal/BD foam than with Cal/BD cream. Use of Cal/BD foam consistently shows significantly greater improvements in PGA and mPASI outcomes, compared with Cal/BD cream."

Journal • Dermatology • Immunology • Psoriasis

Sub-population analysis of patients with plaque psoriasis treated with calcipotriol/betamethasone aerosol foam; effectiveness and patient satisfaction, according to baseline disease severity and prior psoriasis treatment experience, in a Greek population. (PubMed, Dermatol Ther) - "Reduction from baseline in psoriasis symptoms was observed in all patient groups. The greatest reductions were observed in treatment-naïve patients with severe disease. Clinically relevant benefits were observed with Cal/BD aerosol foam in psoriasis patients, regardless of prior treatment-experience and disease severity at baseline."

Journal • Dermatology • Immunology • Psoriasis

[VIRTUAL] Mayne Pharma_Evaluation of the Safety, Tolerability, Pharmacodynamics, and Treatment Effect of Calcipotriene Foam in Pediatric Patients with Plaque Psoriasis_Hebert et al. 2019 (SDDS 2021) - No abstract available

Clinical • PK/PD data • Dermatology • Immunology • Pediatrics • Psoriasis

[VIRTUAL] Evaluation of Calcipotriene Foam in Pediatric Patients with Plaque Psoriasis (SBS 2021) - "Calcipotriene foam, 0.005%, was well tolerated with a low incidence of adverse events. There were no quantifiable systemic concentrations of calcipotriene nor effect seen on calcium metabolism. The results are consistent with previously reported clinical findings, indicating this treatment is a safe, well tolerated, and effective treatment option for pediatric psoriasis patients and the pediatric indication (ages 4+) was approved by the FDA in 2019."

Clinical • Dermatology • Immunology • Pediatrics • Psoriasis

Combination Topical Therapy for Treatment of Scalp Actinic Keratoses (clinicaltrials.gov) - P1; N=15; Terminated; Sponsor: Tulane University; Not yet recruiting ➔ Terminated; The study team was not able to start the study and they never completed the IRB submission, so the study was terminated.

Trial termination • Actinic Keratosis • Dermatology

Evaluating calcipotriene 0.005% foam for the treatment of plaque psoriasis of the scalp and body in patients aged 12 years and older. (PubMed, Expert Opin Pharmacother) - "The authors offer an expert opinion and future perspectives on the use of calcipotriene foam as monotherapy compared with other topical pharmacotherapies...Despite its safety and efficacy, it remains largely utilized as a second-line agent due to its slow clinical improvement. Slow onset of action can result in poor patient adherence."

Clinical • Journal • Dermatology • Immunology • Psoriasis

[VIRTUAL] Real World Patient Perceptions of the use of Calcipotriene Foam 0.005% in the Treatment of Plaque Psoriasis (FCPANP 2020) - "Abstract not available."

Clinical • Real-World Evidence • Dermatology • Immunology • Psoriasis

[VIRTUAL] A Multicenter, Open Label, Phase 1 Study of the Safety, Tolerability, Systemic Exposure, Pharmacodynamics, and Treatment Effect of Calcipotriene Foam, 0.005% in Pediatric Subjects (Ages 2 to 11 Years) with Plaque Psoriasis (FCPANP 2020) - "Abstract not available."

Clinical • P1 data • PK/PD data • Dermatology • Immunology • Pediatrics • Psoriasis

Efficacy and Safety of Sorilux in Maintenance Treatment of Moderate Type Plaque Psoriasis (clinicaltrials.gov) - P4; N=30; Not yet recruiting; Sponsor: Skin Sciences, PLLC

Clinical • New P4 trial • Dermatology • Immunology • Psoriasis

Effectiveness, safety, quality of life and satisfaction of patients with palmar-plantar psoriasis tra- treated with calcipotriol foam and betamethasone (AEDV 2020) - No abstract available

Clinical • HEOR • Dermatology • Immunology • Psoriasis

Safety of calcipotriene and betamethasone dipropionate foam for the treatment of psoriasis. (PubMed, Expert Opin Drug Saf) - "Calcipotriene 0.05% and betamethasone dipropionate 0.064% (Cal/BD) in aerosol foam (Enstilar®) is a novel formulation, which has shown promising results in terms of efficacy and safety.Areas covered: This review evaluates the safety profile of Cal/BD aerosol foam and also the key points regarding to its efficacy...As a result of its unique formulation, it is easily spread, is rapidly absorbed, and has a rapid onset of action. These features upgrade patient's satisfaction and they may increase adherence to topical therapy."

Clinical • Journal

Effectiveness comparison and incremental cost-per-responder analysis of calcipotriene 0.005%/betamethasone dipropionate 0.064% foam vs halobetasol 0.01%/tazarotene 0.045% lotion for plaque psoriasis: A matching-adjusted indirect comparative analysis. (PubMed, J Med Econ) - "The number needed to treat with Cal/BD foam was also less than HP/TAZ lotion (1.9 vs 3.3). Using US wholesale acquisition costs and equal weekly consumption rates, the incremental cost per PGA 0/1 responder relative to vehicle for Cal/BD foam was $3988 and is 37% lower compared with HP/TAZ lotion ($6294). The indirect comparison analyses showed that Cal/BD foam was associated with a greater rate of treatment success, lower ICPR, and quicker treatment response than HP/TAZ lotion in adult patients with moderate-to-severe plaque psoriasis."

HEOR • Journal

Expanded table: some drugs for psoriasis. (PubMed, Med Lett Drugs Ther) - No abstract available.

Journal

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

Journal

Non-invasive clinical and microscopic evaluation of the response to treatment with clobetasol cream vs betamethasone dipropionate/calcipotriol foam in plaque psoriasis (EADV 2019) - No abstract available.

Clinical

Combination Topical Therapy for Treatment of Scalp Actinic Keratoses (clinicaltrials.gov) - P1; N=15; Not yet recruiting; Sponsor: Tulane University

New P1 trial

Treatment of moderate to severe psoriasis with apremilast over two years in the context of long-term treated HIV infection: a case report (AAD 2019) - "...Methotrexate and cyclosporine may carry further risk of immunosuppression (1). Cases of safe treatment with TNF-alpha inhibitors and ustekinumab have been reported (2,3), as well as one case report using apremilast (4). We present the case of a patient with longstanding HIV that was well-controlled on abacavir/lamivudine and efavirenz...He was also known for obesity, type 2 diabetes and hypertriglyceridemia (394 mg/dl despite rosuvastatin and fenofibrate)...A trial of betamethasone dipropionate 0.05%/calcipotriol foam was only minimally helpful. Phototherapy was impractical for this patient and his hypertriglyceridemia made use of acitretin potentially unsafe...To our knowledge, this represents the second case of treatment of psoriasis with apremilast in a patient with HIV in the literature. While selection of systemic treatments for psoriasis in patients with HIV remains complex due to their exclusion from clinical trials, case reports of successful outcomes provide..."

Clinical

Evaluate Safety and Tolerability of Calcipotriene Foam 0.005% in Pediatric Subjects With Mild/Moderate Plaque Psoriasis (clinicaltrials.gov) - P1; N=36; Completed; Sponsor: Mayne Pharma International Pty Ltd; Recruiting ➔ Completed; N=75 ➔ 36; Trial completion date: Apr 2019 ➔ Aug 2018; Trial primary completion date: Apr 2019 ➔ Aug 2018

Clinical • Enrollment change • Trial completion • Trial completion date • Trial primary completion date