ArticleCase reports in dermatology
A New Restrictive Composite Endpoint to Assess Best Response in Patients with Mild-to-Moderate Psoriasis Treated with CAL/BDP PAD Cream: A Case Series.
Article in Case reports in dermatology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03802344 (A Randomised, Multicentre, Investigator-Blind, Parallel-Group Trial to Evaluate the Efficacy and Safety of MC2-01 Cream Compared to Vehicle and Active Comparator in Subjects With Mild-to-Moderate Psoriasis Vulgaris), which is not on this map. Not yet cited in PubMed.
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A Randomised, Multicentre, Investigator-Blind, Parallel-Group Trial to Evaluate the Efficacy and Safety of MC2-01 Cream Compared to Vehicle and Active Comparator in Subjects With Mild-to-Moderate Psoriasis Vulgaris
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Abstract
Introduction: In the assessment of a psoriasis treatment, traditional endpoints evaluated independently may not fully capture the multidimensional nature of treatment response. Best response to calcipotriol/betamethasone dipropionate (CAL/BDP) cream based on polyaphron dispersion (PAD) technology has recently been defined as a restrictive composite endpoint comprising two efficacy outcomes (Physician's Global Assessment [PGA] 0-1 and modified Psoriasis Area and Severity Index [mPASI] <2) and one quality-of-life outcome (Dermatology Life Quality Index [DLQI] 0-1). Case Presentations: This retrospective case series aims to provide further insights into the demographics and outcomes of patients achieving best response to CAL/BDP PAD cream based on this newly defined composite endpoint. From the 213 patients with mild-to-moderate psoriasis who received CAL/BDP PAD cream in the European MC2-01-C7 phase 3 clinical trial (NCT03802344), 7 patients who achieved best response at week 4 and/or week 8 and had available clinical photographs were evaluated. The mean patient age was 55.0 years (range: 34-68), with a mean psoriasis duration of 19.9 years (range: 6.9-29.1). Results support the efficacy of CAL/BDP PAD cream in improving both clinical signs and quality of life. Conclusion: Despite existing variability in key baseline characteristics and long disease duration, all included patients met the novel restrictive composite endpoint after 8 weeks, which reflects complete/almost complete clearance of psoriasis and no impact on patient quality of life.
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