At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 237 enrolled
Drug / intervention
V0034CR01B +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Long-term Efficacy and Safety of V0034 CR 01B Cream in Patients With Moderate-to-severe Uremic Xerosis
In Brief
A Phase 3 clinical trial evaluating V0034CR01B and V0034CR01B vehicle for Uremic Xerosis. Completed, enrolled 237 participants.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUremic Xerosis
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2007
Primary CompletionJan 2009
Study CompletionMar 2009
First PostedMar 2010
TodayJul 2026
First PostedMar 10, 2010
Enrollment StartJan 1, 2007
Primary CompletionJan 1, 2009
Study CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 16.3 years ago
Interventions
V0034CR01Bdrug
V0034CR01B vehicledrug