Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2026-01-01 @ 2:00 AM
Study NCT ID:
NCT06751433
Status:
RECRUITING
Last Update Posted:
2025-09-11
First Post:
2024-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Clinical, Perceived and Instrumental Efficacy of a Scar Gel in Preventing Hypertrophic Scars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017439', 'term': 'Cicatrix, Hypertrophic'}, {'id': 'D007627', 'term': 'Keloid'}], 'ancestors': [{'id': 'D002921', 'term': 'Cicatrix'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003095', 'term': 'Collagen Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Clinical trial, double arm, double blind, randomized'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-09', 'studyFirstSubmitDate': '2024-12-20', 'studyFirstSubmitQcDate': '2024-12-20', 'lastUpdatePostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of clinical and perceived efficacy', 'timeFrame': '90 days', 'description': 'Evaluate the prevention of hypertrophic scars after 90 days of continuous use of the investigational product. The dermatologist will perform assessments of the clinical parameters using the POSAS scale.'}], 'secondaryOutcomes': [{'measure': 'Perceived efficacy', 'timeFrame': '90 days', 'description': 'To compare the treatments of the benchmark product versus the investigational product in improving the appearance of scars, discomfort, skin hydration, itching and normalization of scar pigmentation, after 90 days of use, through a questionnaire on perceived efficacy.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acceptability Study', 'Real-use Conditions', 'Safety and Efficacy', 'Topical Administration', 'Hypertrophic Scars', 'Keloid Scars']}, 'descriptionModule': {'briefSummary': 'Evaluation of the safety and topical efficacy of a scar gel after 90 days of continuous use, comparing it to a benchmark for preventing hypertrophic scars and improving appearance, hydration and pigmentation.', 'detailedDescription': 'Evaluation of the safety and topical efficacy of a scar gel after 90 days of continuous use. Comparison of the efficacy of the investigational product with the benchmark product in preventing hypertrophic scars and improving scar appearance, as well as analyzing parameters such as skin hydration, pruritus, discomfort, and normalization of scar pigmentation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participants of both sexes aged between 18 and 70 years;\n2. Participants with recent scars (\\<30 days);\n3. Participants with phototypes III to VI according to the Fitzpatrick scale;\n4. Agree to follow the trial procedures and attend the center on the days and times determined for evaluations;\n5. Understand, agree to and sign the free and informed consent form.\n6. Types of scars: cesarean section, breast implant or blunt cut injury.\n\nExclusion Criteria:\n\n1. Pregnancy or risk of pregnancy;\n2. History of atopic or allergic reactions to cosmetic products;\n3. Participants who are using topical antibiotics or other skin products on the same area being evaluated;\n4. Immunosuppression due to drugs or active diseases;\n5. Decompensated endocrine diseases;\n6. Relevant clinical history or current evidence of alcohol or other drug abuse;\n7. Known history or suspected intolerance to products in the same category;\n8. Intense sun exposure up to 15 days before the evaluation;\n9. Patients who are using topical antibiotics or other skin products on the same area being evaluated.'}, 'identificationModule': {'nctId': 'NCT06751433', 'briefTitle': 'Evaluation of Clinical, Perceived and Instrumental Efficacy of a Scar Gel in Preventing Hypertrophic Scars', 'organization': {'class': 'INDUSTRY', 'fullName': 'Herbarium Laboratorio Botanico Ltda'}, 'officialTitle': 'Evaluation of Clinical, Perceived and Instrumental Efficacy of a Scar Gel Versus Benchmark in Preventing Hypertrophic Scars and Improving Scar Appearance', 'orgStudyIdInfo': {'id': 'ORC-137032_EN-24-0252-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Participants of both sexes, 18 - 70 y', 'description': 'Participants of both sexes, 18 - 70 y, who have recent scars.', 'interventionNames': ['Device: Scar gel comparator']}, {'type': 'EXPERIMENTAL', 'label': 'Exp.: Participants of both sexes, 18 - 70 y', 'description': 'Participants of both sexes, 18 - 70 y, with recent scars', 'interventionNames': ['Device: Scar gel']}], 'interventions': [{'name': 'Scar gel', 'type': 'DEVICE', 'description': 'Health care product (scar gel)', 'armGroupLabels': ['Exp.: Participants of both sexes, 18 - 70 y']}, {'name': 'Scar gel comparator', 'type': 'DEVICE', 'description': 'Health care product (Scar gel comparator)', 'armGroupLabels': ['Participants of both sexes, 18 - 70 y']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Osasco', 'state': 'São Paulo', 'status': 'NOT_YET_RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Flávia A. S. Addor', 'role': 'CONTACT', 'email': 'contato@medcinpesquisa.com.br', 'phone': '(55) 11 3683-5366'}], 'facility': 'Medcin Instituto da Pele Ltda', 'geoPoint': {'lat': -23.5325, 'lon': -46.79167}}, {'city': 'Osasco', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Addor', 'role': 'CONTACT', 'email': 'contato@medcinpesquisa.com.br', 'phone': '(55) (11) 3683-5366'}], 'facility': 'MEDCIN', 'geoPoint': {'lat': -23.5325, 'lon': -46.79167}}], 'centralContacts': [{'name': 'Flávia A. S. Addor', 'role': 'CONTACT', 'email': 'contato@medcinpesquisa.com.br', 'phone': '(55) 11 3683-5366'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herbarium Laboratorio Botanico Ltda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}