Long-Term Efficacy and Tolerability of an Emollient Containing Glycerol and Paraffin for Moderate-to-Severe Uremic Xerosis: A Randomized Phase 3 Study.

Autor: Szepietowski JC; Faculty of Medicine, Wroclaw University of Science and Technology, Grunwaldzki Sq. 11, 51-377, Wroclaw, Poland. jacek.szepietowski1907@gmail.com., Kemeny L; Department of Dermatology and Allergology, University of Szeged, Szeged, Hungary., Mettang T; Zentrum für Nieren und Hochdruckkrankheiten, Wiesbaden, Germany., Arenberger P; Department of Dermatovenereology, Charles University Third Faculty of Medicine, and Kralovske Vinohrady University Hospital, Prague, Czech Republic.
Jazyk: angličtina
Zdroj: Dermatology and therapy [Dermatol Ther (Heidelb)] 2024 Nov; Vol. 14 (11), pp. 3033-3046. Date of Electronic Publication: 2024 Oct 18.
DOI: 10.1007/s13555-024-01287-w
Abstrakt: Introduction: There is an unmet need for effective topical therapies for patients with uremic xerosis and chronic kidney disease-associated pruritus (CKD-aP). The long-term efficacy and tolerability of an emollient containing glycerol 15% and paraffin 10% (V0034CR) was evaluated in a phase 3 study.
Methods: In this randomized, double-blind, two-parallel group, vehicle-controlled study, patients with moderate-to-severe uremic xerosis were randomized to once-daily application of V0034CR or vehicle control for 28 days (period I). This was followed by a treatment-free period of ≤ 21 days (period II), then all patients received open-label treatment with V0034CR for ≥ 84 days (period III). Outcomes included treatment response at the end of period I (El Gammal's xerosis severity score), instrumental measures of scaling (D-Squame technique), time to relapse during period II, rate of recurrence during period III, pruritus severity over time, patient acceptability, and adverse events (AEs).
Results: The intent-to-treat population comprised 235 patients randomized to V0034CR (n = 118) or vehicle control (n = 117) during period I. Treatment response at the end of period I was achieved by 71 patients (60.2%) in the V0034CR group versus 48 (41.0%) with vehicle control (p = 0.0041). This coincided with greater reductions in the total surface area of squames (p = 0.001 vs vehicle control). Xerosis relapsed progressively without treatment in period II; however, remission was durable under maintenance therapy in period III. Improvements in pruritus severity were comparable between V0034CR and vehicle control, suggesting that the antipruritic effect of V0034CR was mainly exerted by its oil-in-water emulsion base. V0034CR had high patient acceptability and was well tolerated; the most common treatment-related AEs were irritation or erythema (2.1%), exacerbated pruritus (1.3%), and vesicles at the application site (0.9%).
Conclusion: These data support the use of V0034CR, with its hydrating and occlusive properties, for the long-term management of patients with moderate-to-severe uremic xerosis and CKD-aP.
Trial Registration: ClinicalTrials.gov identifier NCT01084148; EudraCT number 2006-002201-31.
Competing Interests: Declarations Conflict of Interest Jacek Szepietowski has served as a consultant and/or advisor for AbbVie, LEO Pharma, Novartis, Pfizer, Pierre Fabre, Sanofi-Genzyme, Trevi, UCB, and Vifor; a speaker for AbbVie, Almirall, Eli Lilly, Janssen-Cilag, LEO Pharma, Novartis, Pfizer, and Sanofi-Genzyme; and an investigator for AbbVie, Almirall, Amgen, AnaptysBio, BMS, Boehringer Ingelheim, Celtrion, Galapagos, Galderma, HELM AG, Incyte, InfraRx, Janssen-Cilag, Kiniksa, LEO Pharma, MedImmune, Menlo Therapeutics, Merck, Novartis, Pfizer, Pierre Fabre, Regeneron, Teva, Trevi, and UCB. Lajos Kemeny and Thomas Mettang have no conflicts of interest to declare. Petr Arenberger has served as a consultant and/or advisor for AbbVie, BMS, LEO Pharma, Novartis, Pfizer, Pierre Fabre, MSD, Sanofi, and UCB; and a speaker for AbbVie, Almirall, BMS, Johnson and Johnson, LEO Pharma, Novartis, MSD, and Pfizer. Ethical Approval This study was conducted in compliance with the Declaration of Helsinki, International Conference on Harmonisation Good Clinical Practice Guidelines, and applicable local laws. The study protocol was approved in each country by applicable independent ethics committees and competent authorities (Supplementary Table S2), and written informed consent was obtained from all participants. This study is registered with ClinicalTrials.gov (NCT01084148) and the European Union Clinical Trials Register (EudraCT 2006-002201-31).
(© 2024. The Author(s).)
Databáze: MEDLINE
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