Calcipotriol 0.005% / Betamethasone dipropionate 0.05% cream

Introduction The aerosol foam formulation of calcipotriol/betamethasone dipropionate (Cal/BD) is an efficacious topical treatment for psoriasis. This study evaluated the efficacy of Cal/BD foam versus ointment in Chinese patients, on the basis of investigator-assessed and patient-reported outcomes (PROs) from a 4-week clinical trial, including post hoc analyses after 2 weeks of treatment. Methods A randomized, investigator-blind, active-controlled, parallel-group phase 3 trial was conducted in China. Native Chinese adults (≥ 18 years) with plaque psoriasis involving 2–30% of the body surface area (BSA), with at least mild disease severity according to the Physician’s Global Assessment (PGA), and modified Psoriasis Area and Severity Index (mPASI) ≥ 2 were randomized 1:1 to receive either Cal/BD foam or ointment once daily for a 4-week treatment period. Efficacy was assessed at weeks 0, 2, and 4 using mPASI, PGA, BSA, Dermatology Life Quality Index (DLQI), Psoriasis Symptom Inventory (PSI), and Subject’s Global Assessment of disease severity (SGA). Results A total of 302 patients were randomized to each treatment. Both groups had clinically meaningful improvements across all outcome measures from baseline to week 2, with sustained or further improvements at week 4. For Cal/BD foam-treated patients, mean change from baseline in mPASI was −59.87% at week 2 (versus ointment: −54.59%; P = 0.010) and −74.69% at week 4 (versus ointment: −70.22%; P = 0.043). Other investigator-assessed outcomes based on mPASI and PGA showed statistically significant treatment differences favoring Cal/BD foam at week 4. Improvements in PROs (DLQI, PSI, and SGA) were numerically slightly greater with Cal/BD foam than ointment, though not statistically significant. For Cal/BD foam-treated patients, mean change from baseline in DLQI was −3.9 at week 2 (versus ointment: −3.7; P = 0.5012) and −5.5 at week 4 (versus ointment: −5.3; P = 0.5119). Conclusions Cal/BD foam showed rapid onset of action with clinically meaningful improvements in signs, symptoms, and quality of life in Chinese patients with plaque psoriasis. Trial Registration ClinicalTrials.gov: NCT05919082. Graphical Abstract Plain Language Summary Plaque psoriasis is the most common type of psoriasis, a chronic disease affecting the skin and other body systems. Plaques are thick, scaly patches of skin that can be itchy and painful, limiting patients’ everyday activities. Plaque psoriasis has a major impact on quality of life, comparable with the impact of other chronic diseases such as cancer and heart disease. Many treatments, such as creams, tablets, and injections, can improve plaque psoriasis, but they do not always work well for everyone. In a clinical trial in China, we tested two treatments—a foam and an ointment—that have the same amount of two active ingredients: calcipotriol (Cal) and betamethasone dipropionate (BD). The goal was to find out if Cal/BD foam, which is the newer treatment, worked as well as Cal/BD ointment in Chinese men and women with plaque psoriasis. The trial participants were randomly distributed into two groups, each with 302 participants. One group applied Cal/BD foam on their plaques and the other group applied Cal/BD ointment, both once daily for 4 weeks. Both groups had meaningful improvements in psoriasis signs and symptoms as well as quality of life already after 2 weeks, with sustained or further improvements after 4 weeks. Overall, the improvements were slightly greater with Cal/BD foam than with Cal/BD ointment. Supplementary Information The online version contains supplementary material available at 10.1007/s13555-026-01763-5.

Abstract licence: CC BY-NC

AbstractA topical medication combining calcipotriol (Cal) and betamethasone dipropionate (BDP) has proven effective in a number of randomized controlled trials performed in patients with psoriasis, but its mechanism of action has not been fully elucidated. We investigated whether the combination of Cal and BDP (Cal/BDP) in this topical medication had a synergistic effect on psoriasis-like dermatitis and explored the underlying immunological mechanisms in a murine psoriasis model induced by application of imiquimod. Cal/BDP synergistically inhibited ear thickening induced by imiquimod compared to monotherapy with either Cal or BDP. In addition, Cal/BDP significantly suppressed the interleukin (IL)-23/IL-17-producing T (T17) pathogenic axis, including expression of IL-17a, IL-23a, IL-22 and TNF-α mRNA in skin lesions and expansion of CCR6+ γδ T17 cells in the draining lymph nodes. Notably, Cal/BDP synergistically induced regulatory CD8+ T cells and also improved the balance between regulatory CD8+ or CD4+ T cells and proinflammatory CCR6+ γδ T17 cells in the draining lymph nodes. These results suggest synergistic anti-psoriatic activity of Cal/BDP with normalization of the imbalance between regulatory CD8+ or CD4+ T cells and proinflammatory CCR6+ γδ T17 cells, which contributes to successful control of psoriasis by Cal-BDP combination therapy.

Abstract licence: CC BY 4.0