Long-term Efficacy and Safety of V0034 CR 01B Cream in Patients With Moderate-to-severe Uremic Xerosis

Summary

Primary objective: To demonstrate the long-term efficacy (response to treatment during initial therapy, time to relapse without treatment, durability and lesional recurrence during maintenance therapy) of V0034 CR 01B cream on uraemic xerosis in the real-life setting. Secondary objectives: 1. To assess the local tolerance of V0034 CR 01B after long-term use 2. To assess the patient benefit and acceptability of V0034 CR 01B

Timeline

Start

2007-01

Primary completion

2009-01

Completion

2009-03

Outcome

Met primary endpoint

paper 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). PMID 39422853 ↗

Publications

• Szepietowski JC, Kemeny L, Mettang T, Arenberger P. Long-Term Efficacy and Tolerability of an Emollient Containing Glycerol and Paraffin for Moderate-to-Severe Uremic Xerosis: A Randomized Phase 3 Study. Dermatol Ther (Heidelb). 2024 Nov;14(11):3033-3046. doi: 10.1007/s13555-024-01287-w. Epub 2024 Oct 18.

Drugs

Indications

No indication recorded.