Ignite Creation Date:
2025-12-24 @ 3:58 PM
Ignite Modification Date:
2026-02-01 @ 12:05 AM
Study NCT ID:
NCT03192592
Status:
UNKNOWN
Last Update Posted:
2017-06-28
First Post:
2017-06-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Effectiveness Evaluation of the Apotech® Diabetic Body Moisturizer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012875', 'term': 'Skin Diseases, Metabolic'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This study aim to verify the improvement of texture, elasticity and general appearance of the skin through the application of the cosmetic product Apotech®.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-07-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-27', 'studyFirstSubmitDate': '2017-06-13', 'studyFirstSubmitQcDate': '2017-06-17', 'lastUpdatePostDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin general appearance', 'timeFrame': '28 days', 'description': 'Standard guide for sensory claim substantiation - ASTM'}, {'measure': 'Skin texture', 'timeFrame': '28 days', 'description': 'Standard guide for sensory claim substantiation - ASTM'}, {'measure': 'Skin hydration', 'timeFrame': '28 days', 'description': 'Standard guide for sensory claim substantiation - ASTM'}, {'measure': 'Skin elasticity and visible cracking', 'timeFrame': '28 days', 'description': 'Standard guide for sensory claim substantiation - ASTM'}], 'secondaryOutcomes': [{'measure': 'Sensory evaluation of the product', 'timeFrame': '28 days', 'description': 'Standard questions'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Skin Diseases, Metabolic', 'Skin Care']}, 'descriptionModule': {'briefSummary': 'Safety and effectiveness evaluation of a new moisturizer formulation with antioxidant, anti-inflammatory and anti-microbial effects in the prevention of diabetics dry skin and complications.', 'detailedDescription': 'Safety and effectiveness evaluation of a new moisturizer formulation with antioxidant, anti-inflammatory and anti-microbial effects in the prevention of diabetics dry skin and complications. This study aim to address the target population, subjects with controlled diabetes, to verify the improvement of texture, elasticity, and general appearance of the skin through the application of the cosmetic product Apotech®.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with controlled diabetes\n* Any phototype and all skin types\n\nExclusion Criteria:\n\n* Pregnant women\n* Subjects that not match the inclusion criteria'}, 'identificationModule': {'nctId': 'NCT03192592', 'acronym': 'Apotech', 'briefTitle': 'Safety and Effectiveness Evaluation of the Apotech® Diabetic Body Moisturizer', 'organization': {'class': 'INDUSTRY', 'fullName': 'ANS Pharma'}, 'officialTitle': 'Safety and Effectiveness Evaluation of a New Moisturizer Formulation With Antioxidant, Anti-inflammatory and Anti-microbial Effects in the Prevention of a Diabetic Skin Dryness and Complications', 'orgStudyIdInfo': {'id': '060935_01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Body moisturizer Apotech®', 'description': 'Instructions for use: Massage the product in the body twice a day (morning and evening) with gentle movements until completely absorption. Daily use for 28 days.', 'interventionNames': ['Other: Body moisturizer']}], 'interventions': [{'name': 'Body moisturizer', 'type': 'OTHER', 'otherNames': ['Apotech® SkinCare'], 'description': 'Daily body moisturizer application for skin protection and barrier.', 'armGroupLabels': ['Body moisturizer Apotech®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13087-548', 'city': 'Campinas', 'state': 'São Paulo - Brazil', 'country': 'Brazil', 'facility': 'Allergisa Pesquisa Dermato-Cosmetica', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}], 'overallOfficials': [{'name': 'Lucas O. Guerra, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Allergisa Pesquisa Dermato-Cosmetica LTDA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ANS Pharma', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Allergisa Pesquisa Dermato-Cosmetica LTDA', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}