WR 279,396 Open Label Treatment Protocol in Tunisia
|ClinicalTrials.gov Identifier: NCT01494350|
Recruitment Status : Terminated (This study was closed prematurely due study team travel restrictions.)
First Posted : December 19, 2011
Results First Posted : December 19, 2014
Last Update Posted : December 19, 2014
|Condition or disease||Intervention/treatment||Phase|
|Cutaneous Leishmaniasis||Drug: WR 279,396 topical cream||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-label Treatment of Non-complicated, Non-severe, Cutaneous Leishmaniasis in Tunisia With WR 279,396 (Paromomycin + Gentamicin Topical Cream) )|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
Experimental: WR 279,396 topical cream
120 subjects will be enrolled to this open label study to receive WR 279,396 topical cream
Drug: WR 279,396 topical cream
WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
- Final Clinical Cure Rate for the Index Lesion [ Time Frame: Final clincial cure is measured at day 98 ]Number of index lesions with 100% reepithelialization at Day 98.
- Area of Index Lesions Throughout the Study [ Time Frame: Measured at day 0, 20, 28, 42, and 98 ]Area (mm^2) of index lesion on Days 0, 20, 28, 42, and 98.
- Number of Index Lesions With Reepithelialization Throughout the Study [ Time Frame: Measured at day 28 and 42 ]Number of index lesions with 100% reepithelialization on Days 28 and 42.
- Area of All Ulcerated Lesions Throughout the Study [ Time Frame: Measured at day 20, 28, 42 and 98 ]Area of all ulcerated lesions on Days 20, 28, 42, and 98.
- Number of All Ulcerated Lesions With Reepithelialization on Day 28 [ Time Frame: Measured on day 28 ]Final cure rate for all ulcerated lesions (100% reepithelialization for ulcerative lesions) on Day 28
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01494350
|Central Clinic-Sidi Bouzid|
|Principal Investigator:||Afif Ben Salah, M.D., Ph.D.||Institute Pasteur Tunisia|