Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-02-13 @ 1:27 PM
Study NCT ID:
NCT06752460
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-30
First Post:
2024-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the EF192B Protection Versus No Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-20', 'studyFirstSubmitDate': '2024-12-11', 'studyFirstSubmitQcDate': '2024-12-20', 'lastUpdatePostDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the effect of EF192B on the curative effect in the protection of small skin lesions through the formation of a barrier, showing its superiority versus no treatment (control) through transepidermal water loss 12 hours after its administration.', 'timeFrame': '12 hours'}], 'secondaryOutcomes': [{'measure': 'Efficacy of the EF192B in barrier formation, showing its superiority versus no treatment (control) through transepidermal water loss 12 hours after its administration.', 'timeFrame': '12 hours'}, {'measure': 'Evaluate the efficacy of EF192B barrier formation through the range of transepidermal water loss 3 minutes, 6 hours, and 24 hours after its administration', 'timeFrame': '24 hours', 'description': 'Evaluation of barrier formation through transepidermal water loss range 3 (±1) minutes, 6 hours (± 10 minutes), and 24 hours (± 30 minutes) after the end of tape stripping versus the measurement obtained immediately after tape stripping (TEWL0)'}, {'measure': 'Evaluate the efficacy of EF192B barrier formation through the range of corneometry 3 minutes, 6 hours, 12 hours, and 24 hours after its administration', 'timeFrame': '24 hours', 'description': 'Evaluation of barrier formation through corneometry range 3 (± 1) minutes, 6 hours (± 10 minutes), 12 hours (± 20 minutes), and 24 hours (± 30 minutes) after the end of tape stripping versus the measurement obtained immediately after tape stripping'}, {'measure': 'Evaluate EF192B water resistance after four washes', 'timeFrame': '12 hours', 'description': 'Water resistance as assessed by the average range of color change to activated charcoal pigment one (01), two (02), three (03), and four (04) washes after administration of the investigational product'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['effectiveness', 'Contact test'], 'conditions': ['Skin Lesions', 'Skin Care']}, 'descriptionModule': {'briefSummary': 'This study was designed with the objective of evaluating the protection potential provided by the experimental product EF192B by evaluating its barrier formation capacity. Once its ability to form a barrier is confirmed, EF192B ability to protect against small skin injuries, such as small cuts, bruises, blisters and cracks is confirmed. The barrier formation also guarantees protection against the formation of calluses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria\n\n* Age between 18 and 70 years old.\n* Fitzpatrick skin phototype classification I to IV.\n* Presence of intact skin in the test region (right forearm and left forearm for selected participants).\n* Agreement to adhere to the study procedures and requirements and attend the institute on the days and times determined for the assessments.\n* Signing of the Informed Consent Form (ICF) and the Image Disclosure Consent Form (IDCF) before carrying out any study procedure.\n\nExclusion Criteria\n\n* Diagnosis of skin diseases such as vitiligo, psoriasis, atopic dermatitis.\n* Diagnosis of immunological insufficiency.\n* Use of systemic corticosteroids or immunosuppressants.\n* Diagnosis of type 1 diabetes mellitus or insulin-dependent diabetes or presence of complications resulting from diabetes (such as retinopathy, nephropathy, neuropathy), presence of diabetes-related dermatoses (such as plantar ulcers, lipoid necrobiosis, granuloma annulare, opportunistic infections), history of episodes of hypoglycemia, diabetic ketoacidosis and/or hyperosmolar coma.\n* History of reaction to liquid dressings.\n* Known hypersensitivity to any ingredients of investigational product formulation.\n* Other diseases or use of drugs that may directly interfere with the study or put the research participant's health at risk.\n* Presence of any serious or uncontrolled diseases, at the investigator's discretion.\n* Pregnancy or lactation.\n* Participation in a clinical research protocol in the last 12 months, unless, at the investigator's discretion, their participation in the study may result in direct benefit to the participant.\n* Presence of any conditions that, at the investigator's discretion, make the participant unable to participate in the study."}, 'identificationModule': {'nctId': 'NCT06752460', 'acronym': 'Spray B', 'briefTitle': 'Evaluation of the EF192B Protection Versus No Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eurofarma Laboratorios S.A.'}, 'officialTitle': 'Randomized, Open Clinical Study to Evaluate the Protective Potential of EF192B Versus No Treatment', 'orgStudyIdInfo': {'id': 'EF192B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EF192B', 'description': 'Application of the EF192B', 'interventionNames': ['Device: EF192B']}, {'type': 'NO_INTERVENTION', 'label': 'Control area'}], 'interventions': [{'name': 'EF192B', 'type': 'DEVICE', 'description': 'EF192B will be applied after the tape strriping procedure and will be reapplied after 12 hours.', 'armGroupLabels': ['EF192B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06696-000', 'city': 'Itapevi', 'state': 'São Paulo', 'country': 'Brazil', 'contacts': [{'name': 'Gleyce Lima', 'role': 'CONTACT', 'email': 'gleyce.lima@eurofarma.com', 'phone': '+55 11 5090-8411'}, {'name': 'Luiza Terranova', 'role': 'CONTACT', 'email': 'luiza.terranova@eurofarma.com', 'phone': '+55 11 5090-8421'}], 'facility': 'Eurofarma Laboratórios S.A', 'geoPoint': {'lat': -23.54889, 'lon': -46.93417}}], 'centralContacts': [{'name': 'Gleyce Lima', 'role': 'CONTACT', 'email': 'gleyce.lima@eurofarma.com', 'phone': '+55 11 5090-8411'}, {'name': 'Luiza Terranova', 'role': 'CONTACT', 'email': 'luiza.terranova@eurofarma.com', 'phone': '+55 11 5090-8421'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eurofarma Laboratorios S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}