Trial reportInternational journal of dermatology2024
Validation of the Peak Pruritus-Numerical Rating Scale in patients with chronic plaque psoriasis: results from a phase 2 study.
Trial report in International journal of dermatology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03850483 (A PHASE 2B, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED, PARALLEL-GROUP, DOSE RANGING STUDY TO ASSESS EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06700841 TOPICAL CREAM APPLIED ONCE OR TWICE DAILY FOR 12 WEEKS IN PARTICIPANTS WITH MILD TO MODERATE CHRONIC PLAQUE PSORIASIS), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A phase 2b, randomized, double blind, vehicle controlled, parallel-group, dose ranging study to assess efficacy, safety, tolerability and pharmacokinetics of pf-06700841 topical cream applied once or twice daily for 12 weeks in participants with mild to moderate chronic plaque psoriasis
Who cites it
1 citing paper in PubMed.
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
backgroundPruritus is a common, bothersome symptom for patients with mild-to-moderate plaque psoriasis (PsO), yet no validated scale assesses it in this patient population. We aimed to validate the Peak Pruritus-Numerical Rating Scale (PP-NRS) using data from a Phase 2b study investigating the efficacy of brepocitinib in patients with mild-to-moderate chronic PsO.
methodsPatients completed the PP-NRS daily from baseline for the first 2 weeks after the dose administration and subsequently only on visit days. Test-retest reliability (intraclass correlation coefficient [ICC]), construct validity (known group validity and convergent validity), ability to detect change, and meaningful within-patient change (MWPC) were evaluated using correlation and regression analyses.
resultsThe PP-NRS demonstrated acceptable test-retest reliability (ICC: 0.86-0.89). Known-group evidence demonstrated that PP-NRS scores could discriminate between different degrees of disease severity. Convergent validity was supported by significant correlation coefficients between the PP-NRS and Patient Global Assessment (PtGA), Dermatology Life Quality Index, and Psoriasis Symptom Inventory, which generally exceeded 0.50. The ability to detect change was evidenced by an approximately linear relationship between changes in PP-NRS and Physician Global Assessment or PtGA of psoriasis scores. The value of 2.8 was determined as the MWPC for the PP-NRS.
conclusionsPP-NRS is a reliable, practical test for assessing pruritus in mild-to-moderate PsO clinical trials. CLINICALTRIALS: GOV IDENTIFIER: NCT03850483.
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