Clinical and experimental dermatology · 2026
Patient- and clinician-reported outcomes of calcipotriol/betamethasone dipropionate PAD-cream for the treatment of adult patients with scalp psoriasis under real-world conditions: results from the prospective, noninterventional, multicentre PRO-SCALP study.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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López Estebaranz Jose Luis, Bewley Anthony, Pinter Andreas, Galván Jordi, Koscielny Volker
Аннотация
BACKGROUND: The novel cream formulation of calcipotriol and betamethasone dipropionate based on polyaphron dispersion technology (CAL/BDP PAD-cream) has shown promising results on psoriasis in phase III clinical trials. However, real-world data on scalp psoriasis are limited.
OBJECTIVES: To assess clinician-reported outcomes (ClinROs) and patient-reported outcomes (PROs) of CAL/BDP PAD-cream in adults with mild-to-moderate scalp psoriasis under real-world conditions in Europe.
METHODS: PRO-SCALP is a prospective, noninterventional, multicentre, cohort study conducted between June 2023 and October 2024 in Germany, Spain and the UK. Data were collected at baseline and week 8 (end of study, EOS). PROs included the Treatment Satisfaction Questionnaire for Medication Version 9 (TSQM-9), Scalpdex questionnaire, Worst Itch-Numerical Rating Scale (WI-NRS), sleep disturbances, the Psychosocial Effects of Scalp Psoriasis Questionnaire and adherence. ClinROs included treatment satisfaction, Physician's Global Assessment of scalp (scalp-PGA) and scalp-modified Psoriasis Area and Severity Index (S-mPASI). The trial was registered at ClinicalTrials.gov (NCT05811234).
RESULTS: In total, 253 patients had evaluable data (mean age 47.9 years; 65.2% female). Of them, 59.9% reported high adherence (visual analogue scale score 80-100). At EOS, the mean (SD) global satisfaction (TSQM-9) was 76.0 (21.6) and 77.6% of patients achieved a scalp-PGA score of 0/1 (clear/almost clear). Moreover, 68.4% achieved scalp-PGA success (scores of 0/1 and ≥ 2-point improvement). WI-NRS, S-mPASI and Scalpdex scores improved significantly (P < 0.001) from baseline to EOS. Sleep patterns and psychosocial outcomes also improved.
CONCLUSIONS: CAL/BDP PAD-cream is associated with high treatment satisfaction and improved clinical outcomes and quality of life in the real-world management of scalp psoriasis.
OBJECTIVES: To assess clinician-reported outcomes (ClinROs) and patient-reported outcomes (PROs) of CAL/BDP PAD-cream in adults with mild-to-moderate scalp psoriasis under real-world conditions in Europe.
METHODS: PRO-SCALP is a prospective, noninterventional, multicentre, cohort study conducted between June 2023 and October 2024 in Germany, Spain and the UK. Data were collected at baseline and week 8 (end of study, EOS). PROs included the Treatment Satisfaction Questionnaire for Medication Version 9 (TSQM-9), Scalpdex questionnaire, Worst Itch-Numerical Rating Scale (WI-NRS), sleep disturbances, the Psychosocial Effects of Scalp Psoriasis Questionnaire and adherence. ClinROs included treatment satisfaction, Physician's Global Assessment of scalp (scalp-PGA) and scalp-modified Psoriasis Area and Severity Index (S-mPASI). The trial was registered at ClinicalTrials.gov (NCT05811234).
RESULTS: In total, 253 patients had evaluable data (mean age 47.9 years; 65.2% female). Of them, 59.9% reported high adherence (visual analogue scale score 80-100). At EOS, the mean (SD) global satisfaction (TSQM-9) was 76.0 (21.6) and 77.6% of patients achieved a scalp-PGA score of 0/1 (clear/almost clear). Moreover, 68.4% achieved scalp-PGA success (scores of 0/1 and ≥ 2-point improvement). WI-NRS, S-mPASI and Scalpdex scores improved significantly (P < 0.001) from baseline to EOS. Sleep patterns and psychosocial outcomes also improved.
CONCLUSIONS: CAL/BDP PAD-cream is associated with high treatment satisfaction and improved clinical outcomes and quality of life in the real-world management of scalp psoriasis.