Cutaneous Leishmaniasis Clinical Trial
Official title:
A Randomized, Double-blind, Pivotal Phase 3 Study of WR 279,396 (Paromomycin + Gentamicin Topical Cream) and Paromomycin Alone Topical Cream for the Treatment of Cutaneous Leishmaniasis in Panama
Verified date | January 2018 |
Source | U.S. Army Medical Research and Materiel Command |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is a pivotal Phase 3, randomized, double-blind, 3-site, two-group trial assessing the efficacy and safety of WR 279,396 Topical Cream and Paromomycin Alone Topical Cream in subjects with CL in Panama. The primary objective of this study is to determine if WR 279,396 results in statistically superior final clinical cure rates of an index lesion when compared with Paromomycin Alone for the treatment of CL in Panama expected to be caused by L panamensis.
Status | Completed |
Enrollment | 399 |
Est. completion date | January 2016 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years and older |
Eligibility |
Inclusion Criteria: - Male or female at least 2 years-of-age - Subject or legal guardian able to give written informed consent or assent, as appropriate - Diagnosis of CL in at least one lesion by at least one of the following methods: 1) positive culture for promastigotes or 2) microscopic identification of amastigotes in stained lesion tissue - At least one ulcerative lesion = 1 cm and = 5 cm that has a diagnosis of CL - Willing to forego other forms of treatments for CL including other investigational treatments during the study - In the opinion of the investigator, subject (or their legal guardian), subject is capable of understanding and complying with the protocol - If female and of child-bearing potential, must have a negative serum pregnancy test during screening and agree to use an acceptable method of birth control during the treatment phase and for 1 week after treatment is completed Exclusion Criteria: - Lesion due to leishmania that involves the nasal or oral mucosa or any signs of mucosal disease that might be due to Leishmania - Only a single lesion on the ear with erosive cartilage - Signs and symptoms of disseminated disease in the opinion of the investigator - More than 10 lesions - Female who is breast-feeding - Significant organ abnormality, chronic disease such as diabetes, severe hearing loss, evidence of renal or hepatic dysfunction, or creatinine, aspartate aminotransferase (AST), or alanine aminotransferase (ALT) greater than 15% above the upper limit of normal (ULN) as defined by the clinical laboratory defined normal ranges - Received treatment for leishmaniasis including any medication with pentavalent antimony including sodium stibogluconate (Pentostam™), meglumine antimoniate (Glucantime™); amphotericin B (including liposomal amphotericin B and amphotericin B deoxycholate); or other medications containing paromomycin (administered parenterally or topically) or methylbenzethonium chloride (MBCL); gentamicin; fluconazole; ketoconazole; pentamidine; miltefosine, azithromycin or allopurinol that was completed within 56 days of starting study treatments - History of known or suspected hypersensitivity or idiosyncratic reactions to aminoglycosides |
Country | Name | City | State |
---|---|---|---|
Panama | Instituto Conmemorativo Gorgas de Estudios de la Salud, | Panama City |
Lead Sponsor | Collaborator |
---|---|
U.S. Army Medical Research and Materiel Command |
Panama,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent of Participants With Final Clinical Cure | The primary efficacy endpoint is percent of subjects with final clinical cure. Final clinical cure is defined as follows: Subject has initial clinical cure (100% re-epithelialization of index lesion by nominal Day 63); OR, Subject has initial clinical improvement (> 50% re-epithelialization of index lesion by nominal Day 63) followed by 100% re-epithelialization of the index lesion on or before nominal Day 100; AND, Subject has no relapse of index lesion. |
baseline (before the start of treatment), and on Study Days 20, 35 ± 2 days, 49 ± 4 days, 63 ± 7 days, 100 ± 14 days, and 168 ± 14 days | |
Secondary | Percentage of Subjects With All Lesions Cured | • Percentage of subjects with all lesions cured, defined as: Final clinical cure as defined in primary objective (which is based solely on the index lesion); AND, Cure of all other lesions by nominal Day 100 (100% re-epithelialization of all ulcerated lesions and resolution of all other types of lesions) | 100 ± 14 days | |
Secondary | Percentage of All Lesions Cured at Day 168 (Ignores Per Subject Cure Rate) | Percentage of all lesions meeting criteria for clinical cure during the study at 168 day mark for mITT subjects | Day 168 | |
Secondary | Area of Ulceration (mm^2) of the Index Lesion at Each Measurement Time Point | Area of ulceration (mm^2) of the index lesion at each measurement time point for mITT subjects | baseline (before the start of treatment), and on Study Days 20, 35 ± 2 days, 49 ± 4 days, 63 ± 7 days, 100 ± 14 days, and 168 ± 14 days | |
Secondary | Area of Ulceration (mm^2) All Treated Lesions at Each Measurement Time Point | Area of ulceration (mm^2) of all treated lesions from baseline (before the start of treatment), and on Study Days 20, 35 ± 2 days, 49 ± 4 days, 63 ± 7 days, 100 ± 14 days, and 168 ± 14 days for mITT subjects. Data presented is as presented in the Final Clinical Study Report; any inconsistencies can't be changed. | baseline (before the start of treatment), and on Study Days 20, 35 ± 2 days, 49 ± 4 days, 63 ± 7 days, 100 ± 14 days, and 168 ± 14 days | |
Secondary | Median Time to Initial Clinical Cure for Index Lesions | Median time to initial clinical cure for index lesions (100% re-epithelialization of the index lesion) | When 100% re-epithelialization of the index lesion is observed at any visit Study Days (20, 35 ± 2 days, 49 ± 4 days, 63 ± 7 days, 100 ± 14 days, and 168 ± 14 days |
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