Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2026-02-05 @ 11:15 PM
Study NCT ID:
NCT03024502
Status:
UNKNOWN
Last Update Posted:
2018-10-19
First Post:
2017-01-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patients With Vulvovaginal Candidiasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002181', 'term': 'Candidiasis, Vulvovaginal'}], 'ancestors': [{'id': 'D002177', 'term': 'Candidiasis'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014848', 'term': 'Vulvovaginitis'}, {'id': 'D014627', 'term': 'Vaginitis'}, {'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D014847', 'term': 'Vulvitis'}, {'id': 'D014845', 'term': 'Vulvar Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003022', 'term': 'Clotrimazole'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-17', 'studyFirstSubmitDate': '2017-01-12', 'studyFirstSubmitQcDate': '2017-01-13', 'lastUpdatePostDateStruct': {'date': '2018-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical cure', 'timeFrame': '10 days', 'description': 'Participants will be evaluated on the tenth day after insertion in the study (on the third day after the termination of the vaginal cream). The clinical cure will be evaluated by means of a questionnaire and specular examination. The possibilities will be:\n\n1. Candidacy Resolution\n2. No resolution of candidiasis\n\nThe questionnaire will be:\n\nPruritus: yes or no Burning: yes or no Dysuria: yes or no Edema of the genital area: yes or no Running: yes or no\n\nThe specular examination will evaluate:\n\nPresence of hyperemia: yes or no Edema of the genital area: yes or no Presence of cracks: yes or no Pathological vaginal contents: yes or no The positive response to any of the questions or signs / symptoms will be considered as clinical failure'}], 'secondaryOutcomes': [{'measure': 'microbiology cure', 'timeFrame': '10 days', 'description': "Participants will be evaluated on the tenth day after insertion in the study (on the third day after the termination of the vaginal cream). The patient's clinical complaint will be evaluated and the specular examination will be performed. In this evaluation will be collected the following exams:\n\nVaginal pH measurement:\n\nNormal 3.5 to 4.5 Abnormal\\> 4.5\n\nBacterioscopy with KOH10%:\n\nNormal: absence of pseudohifas or other pathogenic elements Abnormal: presence of pseudohifas\n\nCulture for candida albicans:\n\nNormal: Negative Abnormal: positive\n\nPCR for candida:\n\nNormal negative Abnormal: positive\n\nThe possibilities will be:\n\n1. Candidacy Resolution\n2. No resolution of candidiasis It will be considered microbiological cure when all laboratory tests are considered normal"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vulvovaginal candidiasis', 'EPPAF mucoadhesive gel', 'clotrimazol'], 'conditions': ['Vulvovaginal Candidiasis']}, 'descriptionModule': {'briefSummary': 'The present study aims to evaluate the safety of two mucoadhesive gels containing a propolis standardized extract identified as EPP-AF, with 1 and 2% of propolis. The efficacy studies with both propolis gels will be performed in comparison with clotrimazole cream in patients presenting vulvovaginal candidiasis.', 'detailedDescription': 'Vaginal candidiasis is the second infection of the genital tract after bacterial vaginosis. Up to 75% of women will have at least one episode in their lives, but the clinical manifestations can be very variable. Around 10 to 20% will be asymptomatic and 5 to 10% will have the recurrent candidiasis that means 4 or more episodes in a year. The predominant symptoms are pruritus in 89% and burning during urination and sexual intercourse in 66%. The therapeutic regimen for acute fungal infections by C. albicans should consider the intensity of the clinical symptoms, recurrence, patient preference for the route of administration and consequent adherence to treatment, presence of pregnancy and the possibility of side effects. In general, the schemes include anti-fungal substances of the azoles type. Intravaginal administration of drugs requires the development of formulations suited to the area and adherence to the treatment can be increased if mucoadhesive formulations are obtained which avoid discomfort and provide adequate release of the active compounds. In this sense, the present project had the objective of developing a mucoadhesive gel containing Propolis Standardized (EPP-AF®) for the treatment of vaginal candidiasis, especially since preclinical efficacy and safety data demonstrated the clinical potential of the product. So the present proposal aims at the clinical study evaluate the efficacy of two formulations with 1 and 2% of propolis in comparison with clotrimazole cream treatment (patients affected by Candidiasis) and also evaluate the safety of both propolis gels in healthy volunteers. The efficacy protocol of the test product in patients with vaginal candidiasis will be performed in an open-label, randomized, three-arm, clinical trial with active clotrimazole-based control. Patients will be recruited (T0) and evaluated at 10 and 30 days after initiation of treatment, and the primary outcome will be the clinical cure rate.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Have performed the clinical and laboratory diagnosis of vulvovaginitis by Candida\n\nExclusion Criteria:\n\n* cPatients with recurrent candidiasis;\n* History of hepatic, renal, hematological, cardiovascular diseases and with decompensated diabetes mellitus (glycemia above 200) and obesity with BMI above 35);\n* Diagnosis of vulvovaginitis by another agent;\n* Make use of chronic antimicrobials (informed by the patient)\n* Be pregnant\n* Allergy to some component of medications given'}, 'identificationModule': {'nctId': 'NCT03024502', 'acronym': 'EPP-AFG-VVC', 'briefTitle': 'Patients With Vulvovaginal Candidiasis', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Randomized Clinical Trial of a Mucoadhesive Gel Containing EPP-AF in Patients Diagnosed With Vulvovaginal Candidiasis', 'orgStudyIdInfo': {'id': '03.12.0056.00'}, 'secondaryIdInfos': [{'id': '2013/50496-2', 'type': 'OTHER_GRANT', 'domain': 'FAPESP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EPP-AF Gel 1%', 'description': 'Group of patients that will be treated with EPP-AF mucoadhesive gel 1%, during 7 day, 1x/day.', 'interventionNames': ['Drug: EPP-AF Gel 1%']}, {'type': 'EXPERIMENTAL', 'label': 'Clotrimazole cream', 'description': 'Group of patients that will be treated with clotrimazole cream, during 7 day, 1x/day.', 'interventionNames': ['Drug: Clotrimazole']}, {'type': 'EXPERIMENTAL', 'label': 'EPP-AF Gel 2%', 'description': 'Group of patients that will be treated with EPP-AF mucoadhesive gel 2%, during 7 day, 1x/day.', 'interventionNames': ['Drug: EPP-AF Gel 2%']}], 'interventions': [{'name': 'EPP-AF Gel 1%', 'type': 'DRUG', 'otherNames': ['Drug 1'], 'description': 'Administration intravaginal of EPP-AG Gel 1%, 1x/day, 7 days', 'armGroupLabels': ['EPP-AF Gel 1%']}, {'name': 'EPP-AF Gel 2%', 'type': 'DRUG', 'otherNames': ['Drug 2'], 'description': 'Administration intravaginal of EPP-AG Gel 1%, 1x/day, 7 days', 'armGroupLabels': ['EPP-AF Gel 2%']}, {'name': 'Clotrimazole', 'type': 'DRUG', 'otherNames': ['Active Comparator'], 'description': 'Administration intravaginal of clotrimazol, 1x/day, 7 days', 'armGroupLabels': ['Clotrimazole cream']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14049-900', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Larissa B Bastos, MSc', 'role': 'CONTACT', 'email': 'larissabbastos4@gmail.com', 'phone': '+55017988034386'}], 'facility': 'Clinical Hospital of Sao Paulo University', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}], 'centralContacts': [{'name': 'silvana ma quintana, phd', 'role': 'CONTACT', 'email': 'quintana@fmrp.usp.br', 'phone': '5516981459112'}, {'name': 'anderson silva, phd', 'role': 'CONTACT', 'email': 'asssilva@fmrp.usp.br', 'phone': '551636021000'}], 'overallOfficials': [{'name': 'silvana m quintana, phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sao Paulo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'clinical professor and principal investigator', 'investigatorFullName': 'Silvana Maria Quintana', 'investigatorAffiliation': 'University of Sao Paulo'}}}}