Ignite Creation Date:
2025-12-24 @ 2:00 PM
Ignite Modification Date:
2025-12-27 @ 9:28 PM
Study NCT ID:
NCT01536795
Status:
COMPLETED
Last Update Posted:
2021-02-12
First Post:
2012-02-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Efficacy and Tolerance of WR279,396 for Old World Cutaneous Leishmaniasis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016773', 'term': 'Leishmaniasis, Cutaneous'}], 'ancestors': [{'id': 'D007896', 'term': 'Leishmaniasis'}, {'id': 'D056986', 'term': 'Euglenozoa Infections'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012876', 'term': 'Skin Diseases, Parasitic'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'afif.bensalah@pateur.rns.tn', 'phone': '011-216-71-792-429', 'title': 'Afif Ben Salah, MD', 'organization': 'Institut Pasteur, Tunisia'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '90 Days', 'eventGroups': [{'id': 'EG000', 'title': 'WR279,396 With Tegaderm Dressing', 'description': '24 patients will be randomly allocated to WR279,396 treatment once-a-day for 20 days with using an occlusive polyurethane Tegaderm dressing\n\nWR279,396 with Tegaderm Dressing: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days with polyurethane dressing', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 16, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'WR279,396 With Gauze and Tape Dressing', 'description': '24 subjects will be randomly allocated to WR279,396 treatment once a day for 20 days without an optimized polyurethane dressing (gauze and tape only).\n\nWR 279,396 with Gauze and Tape Dressing: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 7, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Local reaction (infection at biopsy site)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Any infection and infestation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Any investigations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Blister (vesicles)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dermatitis contact (allergy to Tegaderm)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety: Overview of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'WR279,396 With Tegaderm Dressing', 'description': '24 patients will be randomly allocated to WR279,396 treatment once-a-day for 20 days with using an occlusive polyurethane Tegaderm dressing\n\nWR279,396 with Tegaderm Dressing: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days with polyurethane dressing'}, {'id': 'OG001', 'title': 'WR279,396 With Gauze and Tape Dressing', 'description': '24 subjects will be randomly allocated to WR279,396 treatment once a day for 20 days without an optimized polyurethane dressing (gauze and tape only).\n\nWR 279,396 with Gauze and Tape Dressing: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days'}], 'classes': [{'title': 'Subjects with atleast 1 AE', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Subjects with an SAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Withdrawals due to an AE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Not due to an AE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During 20 day treatment period', 'description': 'Safety of WR279,396 through the tracking of local, systemic and spontaneous adverse reactions', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Responses of Index Lesions (100% Re-epithelialization)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'WR279,396 With Tegaderm Dressing', 'description': '24 patients will be randomly allocated to WR279,396 treatment once-a-day for 20 days with using an occlusive polyurethane Tegaderm dressing\n\nWR279,396 with Tegaderm Dressing: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days with polyurethane dressing'}, {'id': 'OG001', 'title': 'WR279,396 With Gauze and Tape Dressing', 'description': '24 subjects will be randomly allocated to WR279,396 treatment once a day for 20 days without an optimized polyurethane dressing (gauze and tape only).\n\nWR 279,396 with Gauze and Tape Dressing: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days'}], 'classes': [{'title': 'Day 50 - Not Evaluable', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Day 50 - Cured', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Day 50 - Improved', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Day 50 - Failure', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 90 - Not Evaluable', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Day 90 - Cured/Improved at D50 with no relapse', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Day 90 - Improved', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Day 90 - Failure', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 50, 90', 'description': 'Efficacy will be evaluated in terms of the number of lesions cured at D50 (D1 is the first day of treatment) with no relapse by Day 90. Complete clinical respoonse is defined as 100% re-epithelialization of the index lesion by Day 50 or a \\> 50% re-epithelialization by Day 50 followed by complete re-epithelialization on or before Day 90, with no relapse ever having occurred from Day 50 through Day 90.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': "Area of the Index Lesion's Ulceration by Study Day", 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'WR279,396 With Tegaderm Dressing', 'description': '24 patients will be randomly allocated to WR279,396 treatment once-a-day for 20 days with using an occlusive polyurethane Tegaderm dressing\n\nWR279,396 with Tegaderm Dressing: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days with polyurethane dressing'}, {'id': 'OG001', 'title': 'WR279,396 With Gauze and Tape Dressing', 'description': '24 subjects will be randomly allocated to WR279,396 treatment once a day for 20 days without an optimized polyurethane dressing (gauze and tape only).\n\nWR 279,396 with Gauze and Tape Dressing: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days'}], 'classes': [{'title': 'Day 0/1', 'categories': [{'measurements': [{'value': '127.0', 'spread': '147.39', 'groupId': 'OG000'}, {'value': '157.69', 'spread': '179.52', 'groupId': 'OG001'}]}]}, {'title': 'Day 10', 'categories': [{'measurements': [{'value': '118.87', 'spread': '106.41', 'groupId': 'OG000'}, {'value': '140.64', 'spread': '157.74', 'groupId': 'OG001'}]}]}, {'title': 'Day 20', 'categories': [{'measurements': [{'value': '115.62', 'spread': '101.45', 'groupId': 'OG000'}, {'value': '153.51', 'spread': '176.37', 'groupId': 'OG001'}]}]}, {'title': 'Day 50', 'categories': [{'measurements': [{'value': '20.0', 'spread': '48.3', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '6.2', 'groupId': 'OG001'}]}]}, {'title': 'Day 90', 'categories': [{'measurements': [{'value': '30.8', 'spread': '117.9', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 10, 20, 50 and 90', 'description': "Area of the index lesion's ulceration over time in mm2", 'unitOfMeasure': 'mm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': "Area of the Index Lesion's Induration by Study Day", 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'WR279,396 With Tegaderm Dressing', 'description': '24 patients will be randomly allocated to WR279,396 treatment once-a-day for 20 days with using an occlusive polyurethane Tegaderm dressing\n\nWR279,396 with Tegaderm Dressing: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days with polyurethane dressing'}, {'id': 'OG001', 'title': 'WR279,396 With Gauze and Tape Dressing', 'description': '24 subjects will be randomly allocated to WR279,396 treatment once a day for 20 days without an optimized polyurethane dressing (gauze and tape only).\n\nWR 279,396 with Gauze and Tape Dressing: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days'}], 'classes': [{'title': 'Day 0/1', 'categories': [{'measurements': [{'value': '360.7', 'spread': '262.5', 'groupId': 'OG000'}, {'value': '505.9', 'spread': '431.6', 'groupId': 'OG001'}]}]}, {'title': 'Day 10', 'categories': [{'measurements': [{'value': '405.14', 'spread': '250.78', 'groupId': 'OG000'}, {'value': '495.25', 'spread': '401.47', 'groupId': 'OG001'}]}]}, {'title': 'Day 20', 'categories': [{'measurements': [{'value': '410.15', 'spread': '269.62', 'groupId': 'OG000'}, {'value': '468.85', 'spread': '344.01', 'groupId': 'OG001'}]}]}, {'title': 'Day 50', 'categories': [{'measurements': [{'value': '122.7', 'spread': '249.8', 'groupId': 'OG000'}, {'value': '148.05', 'spread': 'NA', 'comment': 'All good cause efforts to locate the data have been exhausted, data are missing and hence not available to be reported.', 'groupId': 'OG001'}]}]}, {'title': 'Day 90', 'categories': [{'measurements': [{'value': '74.6', 'spread': '235.4', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 10, 20, 50 and 90', 'description': "Area of the index lesion's induration over time in mm2", 'unitOfMeasure': 'mm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'On D50 in the Gauze-Tape group no SD was given in the data table. All good cause efforts to locate the data for Day 50 SD value for gauze and tape dressing arm have been exhausted, data are missing and hence not available to be reported.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage Change in Induration Area From Baseline and Days 10, 20, 50 and 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'WR279,396 With Tegaderm Dressing', 'description': '24 patients will be randomly allocated to WR279,396 treatment once-a-day for 20 days with using an occlusive polyurethane Tegaderm dressing\n\nWR279,396 with Tegaderm Dressing: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days with polyurethane dressing'}, {'id': 'OG001', 'title': 'WR279,396 With Gauze and Tape Dressing', 'description': '24 subjects will be randomly allocated to WR279,396 treatment once a day for 20 days without an optimized polyurethane dressing (gauze and tape only).\n\nWR 279,396 with Gauze and Tape Dressing: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days'}], 'classes': [{'title': 'Day 10', 'categories': [{'measurements': [{'value': '28.3', 'spread': '63.2', 'groupId': 'OG000'}, {'value': '45.0', 'spread': '114.2', 'groupId': 'OG001'}]}]}, {'title': 'Day 20', 'categories': [{'measurements': [{'value': '30.0', 'spread': '62.0', 'groupId': 'OG000'}, {'value': '51.0', 'spread': '116.2', 'groupId': 'OG001'}]}]}, {'title': 'Day 50', 'categories': [{'measurements': [{'value': '-64.4', 'spread': '78.5', 'groupId': 'OG000'}, {'value': '-83.9', 'spread': '30.7', 'groupId': 'OG001'}]}]}, {'title': 'Day 90', 'categories': [{'measurements': [{'value': '-65.1', 'spread': '98.5', 'groupId': 'OG000'}, {'value': '-100.0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 10, 20, 50 and 90', 'description': 'Percentage of change of index lesion in induration area from baseline and days 10, 20, 50 and 90', 'unitOfMeasure': '% change in induration', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'WR279,396 With Tegaderm Dressing', 'description': '24 patients will be randomly allocated to WR279,396 treatment once-a-day for 20 days with using an occlusive polyurethane Tegaderm dressing\n\nWR279,396 with Tegaderm Dressing: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days with polyurethane dressing'}, {'id': 'FG001', 'title': 'WR279,396 With Gauze and Tape Dressing', 'description': '24 subjects will be randomly allocated to WR279,396 treatment once a day for 20 days without an optimized polyurethane dressing (gauze and tape only).\n\nWR 279,396 with Gauze and Tape Dressing: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '48 subjects were randomized and received treatment at the Institut Pasteur de Tunis and primary healthcare centers and schools of the study area in Sidi Bouzid and Elmmara, Tunisia.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'WR279,396 With Tegaderm Dressing', 'description': '24 patients will be randomly allocated to WR279,396 treatment once-a-day for 20 days with using an occlusive polyurethane Tegaderm dressing\n\nWR279,396 with Tegaderm Dressing: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days with polyurethane dressing'}, {'id': 'BG001', 'title': 'WR279,396 With Gauze and Tape Dressing', 'description': '24 subjects will be randomly allocated to WR279,396 treatment once a day for 20 days without an optimized polyurethane dressing (gauze and tape only).\n\nWR 279,396 with Gauze and Tape Dressing: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'Middle Eastern or North African', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Other (European/Arab)', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Tunisia', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Subjects with a previous history of leishmaniasis', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-10', 'studyFirstSubmitDate': '2012-02-16', 'resultsFirstSubmitDate': '2017-03-15', 'studyFirstSubmitQcDate': '2012-02-21', 'lastUpdatePostDateStruct': {'date': '2021-02-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-11', 'studyFirstPostDateStruct': {'date': '2012-02-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "Area of the Index Lesion's Ulceration by Study Day", 'timeFrame': 'Days 1, 10, 20, 50 and 90', 'description': "Area of the index lesion's ulceration over time in mm2"}, {'measure': "Area of the Index Lesion's Induration by Study Day", 'timeFrame': 'Days 1, 10, 20, 50 and 90', 'description': "Area of the index lesion's induration over time in mm2"}, {'measure': 'Percentage Change in Induration Area From Baseline and Days 10, 20, 50 and 90', 'timeFrame': 'Days 10, 20, 50 and 90', 'description': 'Percentage of change of index lesion in induration area from baseline and days 10, 20, 50 and 90'}], 'primaryOutcomes': [{'measure': 'Safety: Overview of Adverse Events', 'timeFrame': 'During 20 day treatment period', 'description': 'Safety of WR279,396 through the tracking of local, systemic and spontaneous adverse reactions'}], 'secondaryOutcomes': [{'measure': 'Clinical Responses of Index Lesions (100% Re-epithelialization)', 'timeFrame': 'Day 50, 90', 'description': 'Efficacy will be evaluated in terms of the number of lesions cured at D50 (D1 is the first day of treatment) with no relapse by Day 90. Complete clinical respoonse is defined as 100% re-epithelialization of the index lesion by Day 50 or a \\> 50% re-epithelialization by Day 50 followed by complete re-epithelialization on or before Day 90, with no relapse ever having occurred from Day 50 through Day 90.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ointment to treat leishmania skin lesions'], 'conditions': ['Old World Cutaneous Leishmaniasis']}, 'descriptionModule': {'briefSummary': 'This Phase 2 study is to determine whether WR279396 with occlusion (a polyurethane dressing) is more effective than WR279396 without occlusion for once daily treatment.\n\nExtensive objective and subjective local tolerance data will also be captured during this trial, as well as surrogate markers (parasite loads and aminoglycosides concentration in the deep dermis) that may help to determine the optimal number and duration of treatments.\n\nThe results from this study will help determine the most practical treatment schedule and will answer questions that are crucial to improve the present treatment regimen with WR279396 which is twice a day for 20 days.', 'detailedDescription': 'Forty-eight patients (48) with Old World cutaneous leishmaniasis will be randomly allocated to WR279396 treatment once a day for 20 days with an optimized polyurethane dressing (occlusion) (24 patients), or without occlusion (24 patients). All patients will be rescued with the standard of care accepted in Tunisia, if the patient is not cured. The active ingredients of WR279396 are two aminoglycosides - paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC).\n\nEach subject will be followed for clinical cure for 90 days after the initiation of treatment. Cure is defined as 100% reepithelialization without relapse by 3 months.\n\nTolerance will be evaluated by local adverse reactions and by laboratory signs of systemic events.\n\nIn addition to the clinical evaluation of the CL lesions, the following parameters/clinical healing surrogates will be investigated:\n\n1. parasite load will be determined in superficial and deep lesional dermis samples at D0 and D10. The mean parasite reduction ratio (parasite load at D10/parasite load at D0) in each group will be compared;\n2. aminoglycoside concentrations in superficial and deep infiltrated dermis in each group will be compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: The study population will be selected from adults (18y) patients and children above 15y in Tunisia (Old World)\n\n* Age: 15 - 75 years old\n* Lesion character: each diameter (horizontal and vertical) of the lesion test must measure 7 mm, the lesion must be primarily ulcerative (i.e., not verrucous or nodular) and located in a biopsy friendly site of the body\n* Parasitological diagnosis: have cutaneous leishmaniasis proven parasitologically in lesion selected for inclusion in study (lesion test).\n* Informed consent: have given written informed consent to participate in the study: (i.e. patient or legal representative).\n\nExclusion Criteria:\n\n* Drug intolerance: history of known or suspected hypersensitivity or idiosyncratic reactions to aminoglycosides in the patient or immediate family members.\n* Previous use of antileishmanial drugs (within 2 months) or present use of routinely nephrotoxic or ototoxic drugs.\n* Potential for follow up: Have less than 4 months time remaining in present address and/or plans to leave the area for more than 30 days.\n* Extent of disease: More than 10 lesions or lesion ³ 5 cm or a lesion less than 2 cm from eye, in the ear, or a lesion in the face, that in the opinion of the attending dermatologist could potentially cause significant disfigurement.\n* Location of disease: mucosal involvement.\n* Disseminated disease: clinically significant lymphadenitis with nodules that are painful and \\> 1 cm in size in the lymphatic drainage of the ulcer.\n* Concomitant medical problems: significant medical problems of the kidney or liver as determined by history and by the following laboratory studies:\n* Kidney: clinically significant abnormalities of urine analysis, serum levels of Creatinine, BUN, total proteins \\> upper limit of normal for the laboratory.\n* Liver: AST or ALT \\> upper limit of normal for the laboratory.\n* General: glucose, Na, K, \\> upper limit of normal or \\< lower limit of normal for the laboratory. Volunteers in whom these normal laboratory values are exceeded by less than 25% will not be automatically excluded. These volunteers will be evaluated on the basis of history, physical, as well as laboratory values.\n* Scheduled or ongoing pregnancy as determined clinical and biological criteria.\n* Presence of signs or symptoms of peripheral neuropathy, myasthenia gravis or neuromuscular block'}, 'identificationModule': {'nctId': 'NCT01536795', 'briefTitle': 'A Study to Evaluate the Efficacy and Tolerance of WR279,396 for Old World Cutaneous Leishmaniasis', 'organization': {'class': 'FED', 'fullName': 'U.S. Army Medical Research and Development Command'}, 'officialTitle': 'Topical Treatment of Old World Cutaneous Leishmaniasis With WR279396 (Paromomycin/Gentamicin Ointment): Efficacy and Tolerance of a Regimen Using an Occlusive Polyurethane Dressing', 'orgStudyIdInfo': {'id': 'A-9768.2'}, 'secondaryIdInfos': [{'id': 'IND50,098', 'type': 'OTHER', 'domain': 'US FDA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'WR279,396 with Tegaderm dressing', 'description': '24 patients will be randomly allocated to WR279,396 treatment once-a-day for 20 days with using an occlusive polyurethane Tegaderm dressing', 'interventionNames': ['Drug: WR279,396 with Tegaderm Dressing']}, {'type': 'EXPERIMENTAL', 'label': 'WR279,396 with Gauze and Tape Dressing', 'description': '24 subjects will be randomly allocated to WR279,396 treatment once a day for 20 days without an optimized polyurethane dressing (gauze and tape only).', 'interventionNames': ['Drug: WR 279,396 with Gauze and Tape Dressing']}], 'interventions': [{'name': 'WR279,396 with Tegaderm Dressing', 'type': 'DRUG', 'description': 'Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days with polyurethane dressing', 'armGroupLabels': ['WR279,396 with Tegaderm dressing']}, {'name': 'WR 279,396 with Gauze and Tape Dressing', 'type': 'DRUG', 'description': 'Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days', 'armGroupLabels': ['WR279,396 with Gauze and Tape Dressing']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tunis', 'country': 'Tunisia', 'facility': 'Institut Pasteur', 'geoPoint': {'lat': 36.81897, 'lon': 10.16579}}], 'overallOfficials': [{'name': 'Afif Ben Salah,, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Pasteur, Tunisia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'U.S. Army Medical Research and Development Command', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}