ArticleDermatology and therapy2024
Long-Term Efficacy and Tolerability of an Emollient Containing Glycerol and Paraffin for Moderate-to-Severe Uremic Xerosis: A Randomized Phase 3 Study.
Article in Dermatology and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01084148 (Long-term Efficacy and Safety of V0034 CR 01B Cream in Patients With Moderate-to-severe Uremic Xerosis), which is not on this map. Cited by 4 papers.
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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.
Long-term Efficacy and Safety of V0034 CR 01B Cream in Patients With Moderate-to-severe Uremic Xerosis
Who cites it
4 citing papers in PubMed.
- Uremic Pruritus in Hemodialysis: Mechanisms, Burden, and Emerging Therapies.Journal of clinical medicine · 2026Review
- Topical regimens for the management of uremic pruritus.Frontiers in medicine · 2026Review
- Pruritus in Uremic Patients: Approaches to Alleviating a Common Symptom in Chronic Kidney Disease.Life (Basel, Switzerland) · 2025Review
- Identification and Management of CKD-Associated Pruritus: Current Insights.International journal of nephrology and renovascular disease · 2024Review
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThere 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.
methodsIn 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).
resultsThe 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%).
conclusionThese 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 registrationClinicalTrials.gov identifier NCT01084148; EudraCT number 2006-002201-31.
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