Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-01-01 @ 3:25 PM
Study NCT ID:
NCT01244256
Status:
SUSPENDED
Last Update Posted:
2022-11-03
First Post:
2010-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Comparative of the Association Beclomethasone Clotrimzaol + Gentamicin in Patients With Acne Contaminated
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005499', 'term': 'Folliculitis'}], 'ancestors': [{'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003022', 'term': 'Clotrimazole'}, {'id': 'D005839', 'term': 'Gentamicins'}, {'id': 'D001507', 'term': 'Beclomethasone'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013258', 'term': 'Steroids, Chlorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2007-09'}, 'lastUpdateSubmitDate': '2022-11-01', 'studyFirstSubmitDate': '2010-10-22', 'studyFirstSubmitQcDate': '2010-11-18', 'lastUpdatePostDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of the treatment in patient with infected dermatoses', 'timeFrame': '21 days of treatment'}], 'secondaryOutcomes': [{'measure': 'evaluate the safety and tolerability of both formulations in the course of treatmen', 'timeFrame': '21 days of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Folliculitis']}, 'descriptionModule': {'briefSummary': 'The objective of this trial is to evaluate the comparative efficacy of the combination of Clotrimazole + Gentamicin + Beclomethasone in study subjects with a condition of contaminated dermatosis showing bilateral symmetrical lesions.', 'detailedDescription': 'The specific objective is to evaluate, by means of analytical propedeutics medical improvement in clinical signs and symptoms related to acne infected, the use of the association: Clotrimazole, Gentamicin and Beclomethasone versus association: Clotrimazole and Gentamicin, which will first be randomized.\n\nThe study should be conducted with 20 research subjects aged over 18 years, of both sexes, showing the framework of bilateral lesions infected with acne, at any stage of evolution. The study subjects will receive treatment with both products, so they can use one in each lesion chosen at random, double-blind.\n\nThus, the proven efficacy and safety and taking all possible adverse events reported, the study sponsor hopes to obtain registration with the Ministry of Health of this new association in the country.\n\nThe association made a proposal was developed by the Laboratory Glenmark Pharmaceuticals Ltd..'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject search of both sexes, regardless of color or social class\n* From age to 18, with good mental health\n* Carriers of two outbreaks of acne contaminated\n* Subjects who agree to return follow-up visits\n* Research subjects who agree to participate and sign the Deed of Consent\n\nExclusion Criteria:\n\n* Subject Research carriers of susceptibility to gentamicin\n* Research subjects suffering from sensitivity to clotrimazole\n* Research subjects suffering from sensitivity to beclomethasone\n* Research subjects who are making use of steroids or steroidal anti-inflammatory and non-steroidal drugs or who made use of topical or oral 15 days ago\n* Research subjects who are doing immunosuppressive treatment\n* Research subjects with a diagnosis of eosinophilic folliculitis or Pseudo-folliculitis barbae and groin\n* Pregnant and lactating'}, 'identificationModule': {'nctId': 'NCT01244256', 'acronym': 'acne', 'briefTitle': 'Efficacy and Comparative of the Association Beclomethasone Clotrimzaol + Gentamicin in Patients With Acne Contaminated', 'organization': {'class': 'INDUSTRY', 'fullName': 'Azidus Brasil'}, 'officialTitle': 'Isolation and Comparative Efficacy of the Combination of beclometasona0, 025% + Gentamicin 0.1% + Clotrimazole 1% Topical Dermatological Cream of GLENMARK PHARMACEUTICALS, in Patients Infected With Acne', 'orgStudyIdInfo': {'id': 'BCGGLE10407'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment with Clotrimazole + Gentamicin + Beclomethasone', 'interventionNames': ['Drug: Clotrimazole + Gentamicin + Beclomethasone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment with Clotrimazole + Gentamicin', 'interventionNames': ['Drug: Clotrimazole + Gentamicin']}], 'interventions': [{'name': 'Clotrimazole + Gentamicin + Beclomethasone', 'type': 'DRUG', 'description': 'Treatment with Clotrimazole + Gentamicin + Beclomethasone', 'armGroupLabels': ['Treatment with Clotrimazole + Gentamicin + Beclomethasone']}, {'name': 'Clotrimazole + Gentamicin', 'type': 'DRUG', 'description': 'Treatment with Clotrimazole + Gentamicin', 'armGroupLabels': ['Treatment with Clotrimazole + Gentamicin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13276245', 'city': 'Valinhos', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'LAL Clinica', 'geoPoint': {'lat': -22.97056, 'lon': -46.99583}}], 'overallOfficials': [{'name': 'Alexandre Frederico, médico', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azidus Brasil'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azidus Brasil', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator Dr. Alexandre Frederico', 'investigatorFullName': 'Azidus Brasil', 'investigatorAffiliation': 'Azidus Brasil'}}}}