| Primary | Final Clinical Cure Rate | Final clinical cure was defined as an index lesion that met the criteria for initial clinical cure without relapse. Definitions for index lesion outcomes were as follows:
- Initial Clinical Improvement: At least 50% to 99% reduction in the size of the measured lesion from the baseline measurement by the Day 42 evaluation.
- Initial Clinical Cure: 100% re-epithelialization (ie, a 0 x 0 length x width measurement) of the lesion at the nominal Day 42 evaluation, or initial clinical improvement followed by 100% re-epithelialization by Day 98.
- Relapse: Initial clinical cure followed by re-ulceration by Day 168, or initial clinical improvement followed by lesion enlargement by Day 168.
- Final Clinical Cure: Initial clinical cure without relapse through study Day 168.Clinical Failure: Lack of at least initial clinical improvement by Day 42, or relapse.
| Modified intention-to-treat (mITT) - all subjects randomized who received at least one treatment of study drug. | Posted | | Number | | participants | | Day 42, 98, and 168 | | | | ID | Title | Description |
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| OG000 | WR 279,396 Topical Treament | WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream) WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing. | | OG001 | Paromomycin Alone Topical Treatment | Paromomycin Alone topical cream (15% paromomycin topical cream) Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing. | | OG002 | Vehicle Placebo Cream | The cream base without the addition of paromomycin or gentamicin Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing. |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| H01: There is no difference in the final clinical cure rate between WR 279,396 and Vehicle AND there is no difference in the final clinical cure rate between Paromomycin Alone and Vehicle. | Chi-squared | | 0.0001 | | | | | | | | | | | | | No | Superiority or Other | | | | H01: There is no difference in the final clinical cure rate between WR 279,396 and Vehicle AND there is no difference in the final clinical cure rate between Paromomycin Alone and Vehicle. |
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| Secondary | Final Clinical Cure Rate (Per Protocol Dataset) | Final clinical cure was defined as an index lesion that met the criteria for initial clinical cure without relapse. Definitions for index lesion outcomes as described in the primary outcome measure. | Per protocol - all randomized subjects who received at least one treatment of study drug and whose outcomes at Day 42, Day 98 (if applicable) and Day 168 could be assessed. However, a subject was still considered per-protocol if withdrawn early for treatment failure. | Posted | | Number | | participants | | Day 42, 98, and 168 | | | | ID | Title | Description |
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| OG000 | WR 279,396 Topical Treament | WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream) WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing. | | OG001 | Paromomycin Alone Topical Treatment | Paromomycin Alone topical cream (15% paromomycin topical cream) Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing. | | OG002 | Vehicle Placebo Cream | |
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| Secondary | Estimated Percentage Subjects With Re-epithelialization of the Index Lesion Without Relapse | For the first of the above analyses, subjects were considered to have endpoint events at the first assessment on or before Day 42 where complete re-epithelialization occurred at the index lesion that was not followed by a later assessment where ulceration was present. Subjects who did not have complete re-epithelialization by Day 42 or who relapsed after Day 42 were censored in the analysis at the Day 42 assessment. This analysis was only to be conducted through Day 42. | | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 42 | | | | ID | Title | Description |
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| OG000 | WR 279,396 Topical Treament | WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream) WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing. | | OG001 | Paromomycin Alone Topical Treatment | Paromomycin Alone topical cream (15% paromomycin topical cream) Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing. | | OG002 |
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| Secondary | Estimated Percentage of Subjects With Re-epithelialization of the Index Lesion Without Relapse at Various Times of Follow-up | | mITT dataset. The data show that 95.8% of the Vehicle-treated subjects remaining in the study at Day 168 (the percentage excludes the 17.6% of subjects who dropped out or were withdrawn early due to treatment failure) had re-epithelialization of the index lesion. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Days 42, 49, and 98 | | | | ID | Title | Description |
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| OG000 | WR 279,396 Topical Treament | WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream) WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing. | | OG001 | Paromomycin Alone Topical Treatment | Paromomycin Alone topical cream (15% paromomycin topical cream) Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing. | | OG002 | Vehicle Placebo Cream | The cream base without the addition of paromomycin or gentamicin Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing. |
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| Secondary | Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 42 | | | Posted | | Number | 95% Confidence Interval | Percentage of lesions | | Days 42 | lesions | Participants | | ID | Title | Description |
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| OG000 | WR 279,396 Topical Treament | WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream) WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing. | | OG001 | Paromomycin Alone Topical Treatment | Paromomycin Alone topical cream (15% paromomycin topical cream) Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing. | | OG002 | Vehicle Placebo Cream | The cream base without the addition of paromomycin or gentamicin Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing. |
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| Secondary | Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 49 | | | Posted | | Number | 95% Confidence Interval | percentage of lesions | | Days 49 | lesions | Participants | | ID | Title | Description |
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| OG000 | WR 279,396 Topical Treament | WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream) WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing. | | OG001 | Paromomycin Alone Topical Treatment | Paromomycin Alone topical cream (15% paromomycin topical cream) Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing. | | OG002 | Vehicle Placebo Cream | The cream base without the addition of paromomycin or gentamicin Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing. |
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| Secondary | Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 98 | | | Posted | | Number | 95% Confidence Interval | percentage of lesions | | Days 98 | lesions | Participants | | ID | Title | Description |
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| OG000 | WR 279,396 Topical Treament | WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream) WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing. | | OG001 | Paromomycin Alone Topical Treatment | Paromomycin Alone topical cream (15% paromomycin topical cream) Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing. | | OG002 | Vehicle Placebo Cream | The cream base without the addition of paromomycin or gentamicin Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing. |
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| Secondary | Number of Subjects Achieving Initial Clinical Improvement of the Index Lesion | | | Posted | | Number | | participants | | Day 42 | | | | ID | Title | Description |
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| OG000 | WR 279,396 Topical Treament | WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream) WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing. | | OG001 | Paromomycin Alone Topical Treatment | Paromomycin Alone topical cream (15% paromomycin topical cream) Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing. | | OG002 | Vehicle Placebo Cream | The cream base without the addition of paromomycin or gentamicin Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing. |
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| Secondary | Number of Subjects Achieving Re-epithelialization of the Index Lesion Without Relapse | Number of Subjects Achieving Re-epithelialization of the Index Lesion by Day 42 without Relapse from Day 42 Onward, Imputing Relapse for any Subject with a Missing Visit after Day 42 | | Posted | | Number | | participants | | Day 168 | | | | ID | Title | Description |
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| OG000 | WR 279,396 Topical Treament | WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream) WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing. | | OG001 | Paromomycin Alone Topical Treatment | Paromomycin Alone topical cream (15% paromomycin topical cream) Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing. | | OG002 | Vehicle Placebo Cream | The cream base without the addition of paromomycin or gentamicin Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing. |
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| Secondary | Number of Subjects Achieving Re-epithelialization of All Treated Ulcerated Lesions Without Subsequent Relapse | Number of Subjects Achieving Re-epithelialization of All Treated Ulcerated Lesions at Day 42 without Subsequent Relapse from Day 42 Onward, | | Posted | | Number | | participants | | Day 168 | | | | ID | Title | Description |
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| OG000 | WR 279,396 Topical Treament | WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream) WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing. | | OG001 | Paromomycin Alone Topical Treatment | Paromomycin Alone topical cream (15% paromomycin topical cream) Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing. | | OG002 | Vehicle Placebo Cream | The cream base without the addition of paromomycin or gentamicin Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing. |
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| Secondary | Number of All Ulcerated Lesions Achieving 100% Re-epithelialization by Day 42 | | | Posted | | Number | | Ulcerated lesions | | Day 42 | Ulcerated lesions | Participants | | ID | Title | Description |
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| OG000 | WR 279,396 Topical Treament | WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream) WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing. | | OG001 | Paromomycin Alone Topical Treatment | Paromomycin Alone topical cream (15% paromomycin topical cream) Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing. | | OG002 | Vehicle Placebo Cream | The cream base without the addition of paromomycin or gentamicin Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing. |
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| Secondary | Number of Subjects With a Relapse on or After Day 42 | | | Posted | | Number | | participants | | Day 168 | | | | ID | Title | Description |
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| OG000 | WR 279,396 Topical Treament | WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream) WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing. | | OG001 | Paromomycin Alone Topical Treatment | Paromomycin Alone topical cream (15% paromomycin topical cream) Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing. | | OG002 | Vehicle Placebo Cream | The cream base without the addition of paromomycin or gentamicin Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing. |
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