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
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Condition or disease | Intervention/treatment | Phase |
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Cutaneous Leishmaniasis | Drug: WR 279,396 topical cream | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
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Experimental: WR 279,396 topical cream
120 subjects will be enrolled to this open label study to receive WR 279,396 topical cream
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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.
Other Names:
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- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- At least 18 years of age
- Subject has a diagnosis of CL in at least one lesion by at least one of the following methods: 1) microscopic identification of amastigotes in stained lesion tissue, or 2) positive culture for promastigotes.
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Subject has a parasitologically confirmed lesion that satisfies the following criteria for an Index lesion:
- ulcerative in character
- lesion size ≥ 1 cm and ≤5 cm (including the area of induration surrounding the lesion)
- not located on the ear, or on a location that in the opinion of the PI is difficult to maintain application of study drug topically.
- Subject has < 7 leishmaniasis total lesions.
- Subject is willing to forego other forms of treatments for CL including other investigational treatments during the study.
- In the opinion of the investigator, the subject (or their legal guardian) is capable of understanding and complying with the protocol.
Exclusion Criteria:
- Female with a positive serum pregnancy test or who is breast feeding.
- History of clinically significant medical problems in the investigator's judgment that might interact, either negatively or positively, with topical treatment of leishmaniasis including any immunocompromising condition.
- Age adjusted blood creatinine or blood urea nitrogen (BUN) levels indicative of clinically significant renal disease or aspartate amino transferase (AST), alanine amino transferase (ALT), or total bilirubin that suggest clinically significant hepatic impairment as judged by the PI or subinvestigator. Note: This study is designed to evaluate populations who may have some renal or hepatic dysfunction as the drug has not been shown to have serum levels that would be expected to show renal or hepatic toxicity and treatment of the general population presenting with CL is highly desired based on its safety profile compared to other leishmanial drugs.
- Evidence of disseminated leishmaniasis.
- Received treatment for leishmaniasis with antimonials or any medication likely, in the opinion of the PI, to modify the course of the Leishmania infection within 56 days of starting study treatments.
- History of known or suspected hypersensitivity or idiosyncratic reactions to aminoglycosides.

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
Tunisia | |
Central Clinic-Sidi Bouzid | |
Tunis, Tunisia |
Principal Investigator: | Afif Ben Salah, M.D., Ph.D. | Institute Pasteur Tunisia |
Responsible Party: | U.S. Army Medical Research and Development Command |
ClinicalTrials.gov Identifier: | NCT01494350 |
Other Study ID Numbers: |
S-10-0006; A-16898.3 |
First Posted: | December 19, 2011 Key Record Dates |
Results First Posted: | December 19, 2014 |
Last Update Posted: | December 19, 2014 |
Last Verified: | December 2014 |
cutaneous leishmaniasis topical treatment Tunisia |
Leishmaniasis Leishmaniasis, Cutaneous Euglenozoa Infections Protozoan Infections Parasitic Diseases Infections Skin Diseases, Parasitic Vector Borne Diseases Skin Diseases, Infectious Skin Diseases |
Gentamicins Paromomycin Anti-Bacterial Agents Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antiprotozoal Agents Antiparasitic Agents |