Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT04940520
Status:
COMPLETED
Last Update Posted:
2021-06-30
First Post:
2021-06-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Alpha-bisabolol for Onychomycosis Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014009', 'term': 'Onychomycosis'}], 'ancestors': [{'id': 'D014005', 'term': 'Tinea'}, {'id': 'D003881', 'term': 'Dermatomycoses'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D009260', 'term': 'Nail Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007834', 'term': 'Lasers'}], 'ancestors': [{'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-25', 'studyFirstSubmitDate': '2021-06-17', 'studyFirstSubmitQcDate': '2021-06-17', 'lastUpdatePostDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Injury area analysis', 'timeFrame': '2 months', 'description': 'All participants will have their nails photographed every 15 days for treatment control and evolution. Theses areas will be compared using the Image J program.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Onychomycosis', 'Phytotherapy', 'Laser Therapy', 'Plant Oils'], 'conditions': ['Onychomycosis']}, 'descriptionModule': {'briefSummary': 'Clinical, interventional, longitudinal study with random sampling. 60 patients will be divided into three groups, group A: control group, drug recommended by the Brazilian Society of Dermatology, group B: alpha bisabolol-based product associated with low-level laser therapy, and group C: alpha bisabolol based product. The topical application will be performed twice a day, while the laser application and photographs of the lesions, every 15 days. Areas of the lesions will be compared.', 'detailedDescription': 'Introduction: Onychomycosis is an infection caused by fungi that feed on keratin, a protein that makes up most of the nails. In patients with diabetes mellitus and onychomycosis, the risk of foot complications is a concern, especially for those who do not perform the practice of self-care of the skin, nails and feet in general correctly, which can trigger an important tissue damage that culminates in limb amputation. One of the alternatives for the treatment are herbal medicines. The application of alpha-bisabolol in the pharmaceutical sector is related to its anti-inflammatory, antispasmodic, antiallergic, drug permeation and deworming properties, having an important action in the morphology of dermatophytic fungal cells. Objectives: Develop and evaluate a pharmaceutical formula with alpha-bisololol for the treatment of onychomycosis. Methods: Clinical, interventional, longitudinal study with random sampling. The study will be held at the Sthomatherapy Clinic of the Nursing Care and Teaching Center at the Samuel Libânio Hospital and at the DermatoCare Clinic Stomatherapy and Podiatry Clinic, Pouso Alegre, MG. 60 patients with onychomycosis will participate in this study, which will be divided into three groups, group A: control group, drug recommended by the Brazilian Society of Dermatology, group B: alpha bisabolol-based product associated with low-level laser therapy, and group C: alpha bisabolol based product. The topical application will be performed twice a day, while the laser application and photographs of the lesions, every 15 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Volunteers with onychomycosis,\n* aged over 18 years.\n\nExclusion Criteria:\n\n* Volunteers have a known allergic process to topical treatment, and those who present an allergic reaction to alpha bisabolol\n* patients with a history of neoplasm in a location close to the nail plate, and patients with psoriasis.\n* Volunteers who withdraw their consent at any time during the research, and those who present an allergic reaction to alpha bisabolol\n* Pregnant women.'}, 'identificationModule': {'nctId': 'NCT04940520', 'briefTitle': 'Alpha-bisabolol for Onychomycosis Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Universidade do Vale do Sapucai'}, 'officialTitle': 'Alpha-bisabolol for Onychomycosis Treatment', 'orgStudyIdInfo': {'id': 'Onicomicose'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Group A: control group, drug recommended by the Brazilian Society of Dermatology', 'interventionNames': ['Biological: Drug recommended by the Brazilian Society of Dermatology']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Alpha-bisabolol and laser', 'description': 'Group B: alpha bisabolol-based product associated with low-level laser therapy', 'interventionNames': ['Combination Product: Alpha bisabolol product and laser']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Alpha bisabolol', 'description': 'Group C: alpha bisabolol based product', 'interventionNames': ['Biological: Alpha bisabolol product']}], 'interventions': [{'name': 'Drug recommended by the Brazilian Society of Dermatology', 'type': 'BIOLOGICAL', 'description': 'Using a drug recommended by the Brazilian Society of Dermatology, twice a day.', 'armGroupLabels': ['Control group']}, {'name': 'Alpha bisabolol product and laser', 'type': 'COMBINATION_PRODUCT', 'description': 'Using alpha bisabolol-based product associated with low-level laser therapy. Alpha bisabolol-based product will be used twice a day, and laser therapy used once every fortnight.', 'armGroupLabels': ['Alpha-bisabolol and laser']}, {'name': 'Alpha bisabolol product', 'type': 'BIOLOGICAL', 'description': 'Using alpha bisabolol-based product twice a day', 'armGroupLabels': ['Alpha bisabolol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37550-000', 'city': 'Pouso Alegre', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Vale do Sapucaí University', 'geoPoint': {'lat': -22.23, 'lon': -45.93639}}], 'overallOfficials': [{'name': 'Adriana R dos Anjos Mendonça, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vale do Sapucaí University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade do Vale do Sapucai', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Adriana Rodrigues dos Anjos Mendonça', 'investigatorAffiliation': 'Universidade do Vale do Sapucai'}}}}