WR 279,396 Open Label Treatment Protocol in Tunisia
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|