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| ID | Type | Description | Link |
|---|---|---|---|
| IND 50098 | Other Identifier | FDA |
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| Name | Class |
|---|---|
| Walter Reed Army Institute of Research (WRAIR) | FED |
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This study is to determine the effectiveness and safety of WR 279,396, a topical cream for the treatment of cutaneous leishmaniasis. This study is to be conducted with a placebo control under double-blind conditions in a local population group in Tunisia where leishmaniasis is endemic.
WR 279,396 is a paromomycin-based topical cream that has shown some suggestion of being effective for the treatment of non-serious, non-complicated cutaneous leishmaniasis in previous clinical studies. The goal of this study is to expand those observations in a larger, more rigorous study to clearly define the efficacy of this product and collect information about adverse effects. Subjects will be randomized to receive either WR 279,396 or vehicle placebo; applied twice a day for 20 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WR 279,396 | Experimental | WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin |
|
| Placebo | Placebo Comparator | Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WR 279,396 | Drug | A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Clinical Response (CCR) of Lesion at Days 50, 100 and 180 (+7 Days) | CCR is defined as at least 50% reduction, from baseline, in index lesion area of ulceration at study days 50, 100 and 180 (+ 7 days). Randomized subjects were compared using the uncorrected Fisher's exact test. Confidence intervals (95%) were constructed on the difference between the two group proportions. The log-rank test was used to compare the time to complete re-epithelialization of the index lesion without relapse. Cure of all subjects lesions was also compared using the Fisher's exact test. To adjust for baseline differences in the treatment groups, a linear model for the proportion of subjects achieving CCR was fit for each baseline variable of interest with covariates for treatment group and the baseline variable. The Breslow-Day test was used to examine whether the effect of WR 279,396 varied between subgroups | 180 days |
| Safety of WR 279,396 (AEs and SAEs) | Safety was evaluated on each day during daily administration of the topical products. Subjects were observed and questioned for the occurrence of solicited local side effects (eg, pain, erythema, edema) and solicited systemic side effects (eg, vertigo, tinnitus, diminished hearing). Non-solicited AE evaluations included spontaneous reports from subjects and clinical observations. | 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Complete Re-epithelialization of the Index Lesion Ulcer Without Relapse | 100% re-epithelialization of the index lesion without having had a relapse. The log-rank test was used to compare the time to complete re-epithelialization. | 180 days |
| Final Cure Rate by Subject of All Lesions |
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Inclusion Criteria:
Exclusion Criteria:
Kidney: clinically significant abnormalities of urine analysis, serum levels of creatinine, BUN, total proteins greater than the upper limit of normal for the laboratory.
Liver: AST or ALT greater than the upper limit of normal for the laboratory General: glucose, Na+, or K+ greater than the upper limit of normal for the laboratory
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| Name | Affiliation | Role |
|---|---|---|
| Afif Ben Salah, M.D., Ph.D. | Institute Pasteur Tunisia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Center Institut Pasteur | Paris | 75015 | France | |||
| Institue Pasteur |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19415122 | Result | Ben Salah A, Buffet PA, Morizot G, Ben Massoud N, Zaatour A, Ben Alaya N, Haj Hamida NB, El Ahmadi Z, Downs MT, Smith PL, Dellagi K, Grogl M. WR279,396, a third generation aminoglycoside ointment for the treatment of Leishmania major cutaneous leishmaniasis: a phase 2, randomized, double blind, placebo controlled study. PLoS Negl Trop Dis. 2009;3(5):e432. doi: 10.1371/journal.pntd.0000432. Epub 2009 May 5. |
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Data will be shared with WRAIR
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| ID | Title | Description |
|---|---|---|
| FG000 | WR 279,396 | WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin WR 279,396: A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion |
| FG001 | Placebo | Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients. Placebo: Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | WR 279,396 | WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin WR 279,396: A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Complete Clinical Response (CCR) of Lesion at Days 50, 100 and 180 (+7 Days) | CCR is defined as at least 50% reduction, from baseline, in index lesion area of ulceration at study days 50, 100 and 180 (+ 7 days). Randomized subjects were compared using the uncorrected Fisher's exact test. Confidence intervals (95%) were constructed on the difference between the two group proportions. The log-rank test was used to compare the time to complete re-epithelialization of the index lesion without relapse. Cure of all subjects lesions was also compared using the Fisher's exact test. To adjust for baseline differences in the treatment groups, a linear model for the proportion of subjects achieving CCR was fit for each baseline variable of interest with covariates for treatment group and the baseline variable. The Breslow-Day test was used to examine whether the effect of WR 279,396 varied between subgroups | Posted | Count of Participants | Participants | 180 days |
|
Duration of study (180 days (+7 days)
AEs were evaluated on each day during daily administration of the topical products. Subjects were observed and questioned for the occurrence of solicited local side effects (eg, pain, erythema, edema) and solicited systemic side effects (eg, vertigo, tinnitus, diminished hearing). Non-solicited AE evaluations included spontaneous reports from subjects and clinical observations.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | WR 279,396 | WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin WR 279,396: A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arm fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Immediate - Local pain | General disorders | MedDRA (Unspecified) | Systematic Assessment | Mild |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Afif Ben Salah, MD, PhD | Institute Pasteur Tunisia | 216-71-792-429 | afif.bensalah@pasteur.rns.tn |
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| ID | Term |
|---|---|
| D016773 | Leishmaniasis, Cutaneous |
| ID | Term |
|---|---|
| D007896 | Leishmaniasis |
| D056986 | Euglenozoa Infections |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
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| Placebo | Drug | Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion |
|
|
Final cure rate by subject was determined using the Fisher's exact test. To adjust for baseline differences in the treatment groups, a linear model for the proportion of subjects achieving CCR was fit for each baseline variable of interest with covariates for treatment group and the baseline variable. |
| 180 days |
| Rate of Relapse | Relapse is defined as enlargement of the index lesion compared to previous measurement at any time after day 50 (+ 7 days) or not demonstrating CCR by study day 180. CCR was compared using uncorrected Fisher's exact test. Confidence intervals (95%) were constructed on the difference between the two group proportions. The log-rank test was used to compare the time to complete re-epithelialization of the index lesion without relapse. Cure of all subjects lesions was also compared using the Fisher's exact test. To adjust for baseline differences in the treatment groups, a linear model for the proportion of subjects achieving CCR was fit for each baseline variable of interest with covariates for treatment group and the baseline variable. | 180 days |
| Tunis |
| Tunisia |
Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients.
Placebo: Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin
WR 279,396: A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion
| OG001 | Placebo | Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients. Placebo: Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion |
|
|
| Primary | Safety of WR 279,396 (AEs and SAEs) | Safety was evaluated on each day during daily administration of the topical products. Subjects were observed and questioned for the occurrence of solicited local side effects (eg, pain, erythema, edema) and solicited systemic side effects (eg, vertigo, tinnitus, diminished hearing). Non-solicited AE evaluations included spontaneous reports from subjects and clinical observations. | All solicited local and systemic AEs and SAEs including immediate and delayed reactions that occurred during this study are summarized. | Posted | Number | Adverse Events | 180 days |
|
|
|
| Secondary | Time to Complete Re-epithelialization of the Index Lesion Ulcer Without Relapse | 100% re-epithelialization of the index lesion without having had a relapse. The log-rank test was used to compare the time to complete re-epithelialization. | Days to 100% re-epithelialization of index lesion. Volunteer Identification Number (VIN). VINs 17, 72, and 109 failed to meet 100% re-epithelialization | Posted | Count of Participants | Participants | 180 days |
|
|
|
| Secondary | Final Cure Rate by Subject of All Lesions | Final cure rate by subject was determined using the Fisher's exact test. To adjust for baseline differences in the treatment groups, a linear model for the proportion of subjects achieving CCR was fit for each baseline variable of interest with covariates for treatment group and the baseline variable. | Posted | Count of Participants | Participants | 180 days |
|
|
|
| Secondary | Rate of Relapse | Relapse is defined as enlargement of the index lesion compared to previous measurement at any time after day 50 (+ 7 days) or not demonstrating CCR by study day 180. CCR was compared using uncorrected Fisher's exact test. Confidence intervals (95%) were constructed on the difference between the two group proportions. The log-rank test was used to compare the time to complete re-epithelialization of the index lesion without relapse. Cure of all subjects lesions was also compared using the Fisher's exact test. To adjust for baseline differences in the treatment groups, a linear model for the proportion of subjects achieving CCR was fit for each baseline variable of interest with covariates for treatment group and the baseline variable. | Posted | Count of Participants | Participants | 180 days |
|
|
|
| 1 |
| 50 |
| 16 |
| 50 |
| EG001 | Placebo | Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients. Placebo: Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion | 0 | 42 | 12 | 42 |
| Immediate - Local pain | General disorders | MedDRA (Unspecified) | Systematic Assessment | Moderate |
|
| Immediate - Local pain | General disorders | MedDRA (Unspecified) | Systematic Assessment | Severe |
|
| Immediate - Local Erythema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Mild |
|
| Immediate - Local Erythema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Moderate |
|
| Immediate - Local Erythema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Severe |
|
| Immediate - Local Edema | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment | Mild |
|
| Immediate - Local Edema | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment | Moderate |
|
| Immediate - Local Edema | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment | Severe |
|
| Immediate - Vertigo | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Immediate - Tinnitus | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Immediate - Hearing loss | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Delayed - Local Pain | General disorders | MedDRA (Unspecified) | Systematic Assessment | Mild |
|
| Delayed - Local Pain | General disorders | MedDRA (Unspecified) | Systematic Assessment | Moderate |
|
| Delayed - Local Pain | General disorders | MedDRA (Unspecified) | Systematic Assessment | Severe |
|
| Delayed - Local Erythema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Mild |
|
| Delayed - Local Erythema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Moderate |
|
| Delayed - Local Erythema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Severe |
|
| Delayed - Local Edema | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment | Mild |
|
| Delayed - Local Edema | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment | Moderate |
|
| Delayed - Local Edema | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment | Severe |
|
| Delayed - Vertigo | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Delayed - Tinnitus | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Delayed - Hearing loss | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment | Moderate |
|
| Application site erythema | General disorders | MedDRA (Unspecified) | Non-systematic Assessment | Moderate |
|
| Application site erythema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment | Mild |
|
| Application site oedema | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment | Mild |
|
| Fatigue | General disorders | MedDRA (Unspecified) | Non-systematic Assessment | Mild |
|
| Fatigue | General disorders | MedDRA (Unspecified) | Non-systematic Assessment | Moderate |
|
| Nodule | General disorders | MedDRA (Unspecified) | Non-systematic Assessment | Mild |
|
| Pain | General disorders | MedDRA (Unspecified) | Non-systematic Assessment | Mild |
|
| Pain | General disorders | MedDRA (Unspecified) | Non-systematic Assessment | Moderate |
|
| Respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment | Moderate |
|
| Respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment | Mild |
|
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment | Severe |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment | Mild |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment | Mild |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment | Moderate |
|
| Insomnia | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment | Mild |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment | Mild |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment | Moderate |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment | Moderate |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (Unspecified) | Non-systematic Assessment | Mild |
|
| Eye pain | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment | Mild |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | Mild |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | Mild |
|
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | Mild |
|
| Bronchitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment | Moderate |
|
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment | Mild |
|
| Anxiety | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment | Mild |
|
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| D007239 |
| Infections |
| D012876 | Skin Diseases, Parasitic |
| D000079426 | Vector Borne Diseases |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| Solicited AEs- Severe |
|
| Non-Solicited AEs- Mild |
|
| Non-Solicited AEs- Moderate |
|
| Non-Soliciated AEs- Severe |
|
| SAEs |
|
|
| Placebo |
|
|