WR 279,396 Open Label Treatment Protocol in Tunisia
Status:
Terminated
Trial end date:
2012-06-01
Target enrollment:
Participant gender:
Summary
The U.S. Army has recently completed a Phase 3 clinical trial in Tunisia. This is an
open-label single site trial designed to expand our safety database and capture additional
efficacy (final clinical cure rate of an index lesion) of WR 279,396 Topical Cream in
Tunisian subjects with non-complicated, non-severe Cutaneous Leishmaniasis (CL). Subjects
will be patients who visit Ministry of Health sponsored clinics in Tunisia who present with
at least one CL lesion that is ulcerated and amenable to topical treatment. Potential trial
subjects will be consented and screened for eligibility including medical history, physical
exam, lesion parasitology, and renal and liver function tests. If eligible for the study,
subjects will receive WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream) (target n
= 110). The cream will be applied topically to all CL lesions once daily for 20 days by an
investigator or study nurse. If a subject develops a new lesion during the study, the new
lesion may also be treated with the topical cream.
Phase:
Phase 2
Details
Lead Sponsor:
U.S. Army Medical Research and Development Command U.S. Army Medical Research and Materiel Command