Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-25 @ 4:28 PM
Study NCT ID:
NCT03096457
Status:
COMPLETED
Last Update Posted:
2021-02-02
First Post:
2017-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Topical Paromomycin for Cutaneous Leishmaniasis in Bolivia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016773', 'term': 'Leishmaniasis, Cutaneous'}, {'id': 'D007897', 'term': 'Leishmaniasis, Mucocutaneous'}, {'id': 'D007896', 'term': 'Leishmaniasis'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010303', 'term': 'Paromomycin'}, {'id': 'D010419', 'term': 'Pentamidine'}], 'ancestors': [{'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D001550', 'term': 'Benzamidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Group 1 (Paromomycin cream) will be compared to Group 3 (Vehicle cream). Both creams will have very similar physical characteristics and package. Group 2 (intralesional injection of pentamidine) will not be masked.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized between Paromomycin cream applied topically once daily for 20 days (group 1--40 patients), pentamidine administered intralesionally at 120 ug/mm2 on days 1, 3, 5 (group 2-20 patients), and cream vehicle applied topically once daily for 20 days (group 3-20 patients).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-01', 'studyFirstSubmitDate': '2017-03-09', 'studyFirstSubmitQcDate': '2017-03-24', 'lastUpdatePostDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Lesion size', 'timeFrame': '6 months', 'description': 'change of lesion area at 6 months after treatment compared to baseline'}], 'secondaryOutcomes': [{'measure': 'Number of participants with treated-related adverse events', 'timeFrame': '1 month', 'description': 'Adverse events will measured according to CTCAE 4.03'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['leishmaniasis', 'L.braziliensis', 'paromomycin cream', 'intralesional pentamidine', 'leishmaniasis local therapy'], 'conditions': ['Leishmaniasis, Cutaneous', 'Leishmania Braziliensis Complex', 'Leishmaniasis, American', 'Leishmaniasis; American, Cutaneous']}, 'referencesModule': {'references': [{'pmid': '9248897', 'type': 'BACKGROUND', 'citation': 'Oliveira-Neto MP, Schubach A, Mattos M, da Costa SC, Pirmez C. Intralesional therapy of American cutaneous leishmaniasis with pentavalent antimony in Rio de Janeiro, Brazil--an area of Leishmania (V.) braziliensis transmission. Int J Dermatol. 1997 Jun;36(6):463-8. doi: 10.1046/j.1365-4362.1997.00188.x.'}, {'pmid': '22855754', 'type': 'BACKGROUND', 'citation': 'Vasconcellos Ede C, Pimentel MI, Schubach Ade O, de Oliveira Rde V, Azeredo-Coutinho RB, Silva Fda C, Salgueiro Mde M, Moreira JS, Madeira Mde F, Baptista C, Valete-Rosalino CM. Intralesional meglumine antimoniate for treatment of cutaneous leishmaniasis patients with contraindication to systemic therapy from Rio de Janeiro (2000 to 2006). Am J Trop Med Hyg. 2012 Aug;87(2):257-60. doi: 10.4269/ajtmh.2012.11-0612.'}, {'pmid': '23390069', 'type': 'BACKGROUND', 'citation': 'Soto J, Rojas E, Guzman M, Verduguez A, Nena W, Maldonado M, Cruz M, Gracia L, Villarroel D, Alavi I, Toledo J, Berman J. Intralesional antimony for single lesions of bolivian cutaneous leishmaniasis. Clin Infect Dis. 2013 May;56(9):1255-60. doi: 10.1093/cid/cit049. Epub 2013 Feb 6.'}, {'pmid': '26903605', 'type': 'BACKGROUND', 'citation': 'Soto J, Paz D, Rivero D, Soto P, Quispe J, Toledo J, Berman J. Intralesional Pentamidine: A Novel Therapy for Single Lesions of Bolivian Cutaneous Leishmaniasis. Am J Trop Med Hyg. 2016 Apr;94(4):852-6. doi: 10.4269/ajtmh.15-0640. Epub 2016 Feb 22.'}, {'pmid': '23388004', 'type': 'BACKGROUND', 'citation': 'Ben Salah A, Ben Messaoud N, Guedri E, Zaatour A, Ben Alaya N, Bettaieb J, Gharbi A, Belhadj Hamida N, Boukthir A, Chlif S, Abdelhamid K, El Ahmadi Z, Louzir H, Mokni M, Morizot G, Buffet P, Smith PL, Kopydlowski KM, Kreishman-Deitrick M, Smith KS, Nielsen CJ, Ullman DR, Norwood JA, Thorne GD, McCarthy WF, Adams RC, Rice RM, Tang D, Berman J, Ransom J, Magill AJ, Grogl M. Topical paromomycin with or without gentamicin for cutaneous leishmaniasis. N Engl J Med. 2013 Feb 7;368(6):524-32. doi: 10.1056/NEJMoa1202657.'}, {'pmid': '30260376', 'type': 'DERIVED', 'citation': 'Soto J, Soto P, Ajata A, Luque C, Tintaya C, Paz D, Rivero D, Berman J. Topical 15% Paromomycin-Aquaphilic for Bolivian Leishmania braziliensis Cutaneous Leishmaniasis: A Randomized, Placebo-controlled Trial. Clin Infect Dis. 2019 Feb 15;68(5):844-849. doi: 10.1093/cid/ciy619.'}]}, 'descriptionModule': {'briefSummary': 'This protocol will compare topical paromomycin to standard intralesional (IL) antimony (Sb) to placebo for L braziliensis in Bolivia.', 'detailedDescription': 'Patients will be randomized between Paromomycin cream applied topically once daily for 20 days (group 1--40 patients), pentamidine administered intralesionally at 120 ug/mm2 on days 1, 3, 5 (group 2-20 patients), and cream vehicle applied topically once daily for 20 days (group 3-20 patients).\n\nAfter treatment, all patients will be followed for 1, 3, and 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Gender: Male or female\n* Age: \\>12 yrs of age\n* Presentation: 1-to-2 ulcerative lesions, each \\< 30 mm in largest diameter and with a total lesion area \\<900 mm2.\n* Parasitology: Parasitological confirmation of the lesion will be made by visualization or culture of Leishmania from the biopsy or aspirate of the lesion.\n\nExclusion Criteria:\n\n* Previous treatment for leishmaniasis with Sb, pentamidine, amphotericin B, miltefosine, imidazoles, allopurinol in the last 3 months.\n* Other diseases that would be likely in the PI's opinion to interact, either positively or negatively, with treatment."}, 'identificationModule': {'nctId': 'NCT03096457', 'briefTitle': 'Topical Paromomycin for Cutaneous Leishmaniasis in Bolivia', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion Nacional de Dermatologia'}, 'officialTitle': 'Topical Paromomycin Cream For Bolivian Cutaneous Eishmaniasis: A Controlled Study', 'orgStudyIdInfo': {'id': 'ABF-BO-2016-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 - Paromomycin cream', 'description': '40 subjects will be included to receive 15% paromomycin in aquafilm base twice a day during 20 consecutive days. The lesion will be cleaned , then, a generous amount of the study drug (an amount sufficient to cover the area of the ulcer and the lesion border) will be applied to the lesion and rubbed into the ulcer using a gloved finger by a member of the clinical study staff. After application of the study drug, the patient will be observed for 15 minutes for signs of adverse events. If there are no signs of local toxicity, the area of the ulcer will be covered with extra study drug. For Days 2-20, the study drug will be applied and the lesion covered with a sterile gauze and tape dressing as on Day 1.', 'interventionNames': ['Drug: Paromomycin Sulfate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2. Local Injectable Pentamidine', 'description': '20 subjects will be included to receive IL pentamidine \\[Pentacarinat® Sanofi-Aventis: 30 mg/ml\\] will administered at a dose of 120 ug (4 ul) per mm2 of lesion area 3 times (on days 1, 3, and 5) as per our previous experience.\n\nA small button of Xylocaine® will be applied by means of a thin needle at the four cardinal points of the lesion and then a small gauge (23g) needle will introduce the drug in each cardinal point. The needle will be moved in all directions to infiltrate of whole lesion and surrounding infiltrated area.', 'interventionNames': ['Drug: Pentamidine Isethionate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 3. Vehicle control', 'description': '10% Urea en parafilm cream will be used in similar ways as paromomycin cream in group 1', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Paromomycin Sulfate', 'type': 'DRUG', 'description': 'topical application 2 times a day during 20 days', 'armGroupLabels': ['Group 1 - Paromomycin cream']}, {'name': 'Pentamidine Isethionate', 'type': 'DRUG', 'description': '3 Intralesional injections at days 1,3 and 5', 'armGroupLabels': ['Group 2. Local Injectable Pentamidine']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'topical application 2 times a day during 20 days', 'armGroupLabels': ['Group 3. Vehicle control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00000', 'city': 'Palos Blancos', 'state': 'La Paz Department', 'country': 'Bolivia', 'facility': 'Hospital Local Palos Blancos'}, {'city': 'Jorochito', 'state': 'SC', 'country': 'Bolivia', 'facility': 'Hospital Dermatologico de Jorochito', 'geoPoint': {'lat': -18.05608, 'lon': -63.42788}}], 'overallOfficials': [{'name': 'JAIME SOTO, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fundacion Nacional de Dermatologia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion Nacional de Dermatologia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}