Topical Treatment of Cutaneous Leishmaniasis W/WR279396 Phase II Study. Addendum
Abstract
In the previous GCP phase 2 clinical study (HSRRB Log# A-9768.1) using investigational drug WR279396, cure rate was found to be 95.8% when evaluated at D50 with no relapse at D180 against L. major Old World Cutaneous Leishmaniasis (CL). During this reporting period, a second phase 2 clinical study was conceived written and initiated (HSRRB Log# A-9768.2 entitled "Topical Treatment of Old World Cutaneous Leishmaniasis with WR279396: Efficacy and tolerance of a regimen using an occlusive polyurethane dressing") that started in January 2006 at the Tunisia site to determine: (a) whether WR279396 when applied under a polyurethane occlusive bandage (Tegaderm trade mark) is more efficient than application of the drug without occlusion; and (b) would administration of WR279396 once-a-day for 20 days be as effective as application twice-a-day for 20 days when compared to the results from study A-9768.1.
Document Details
- Document Type
- Technical Report
- Publication Date
- Jul 01, 2006
- Accession Number
- ADA449947
Entities
People
- Pierre Buffet