Trials / Completed
CompletedNCT01084148
Long-term Efficacy and Safety of V0034 CR 01B Cream in Patients With Moderate-to-severe Uremic Xerosis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 237 (actual)
- Sponsor
- Orfagen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | V0034CR01B | |
| DRUG | V0034CR01B vehicle |
Timeline
- Start date
- 2007-01-01
- Primary completion
- 2009-01-01
- Completion
- 2009-03-01
- First posted
- 2010-03-10
- Last updated
- 2017-12-20
- Results posted
- 2014-03-18
Source: ClinicalTrials.gov record NCT01084148. Inclusion in this directory is not an endorsement.