Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-02-21 @ 10:11 PM
Study NCT ID:
NCT03629405
Status:
COMPLETED
Last Update Posted:
2018-08-14
First Post:
2018-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of the Efficacy and Barrier Protection of Two Cosmetic Products
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2016-09-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-10', 'studyFirstSubmitDate': '2018-08-10', 'studyFirstSubmitQcDate': '2018-08-10', 'lastUpdatePostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin pH', 'timeFrame': 'baseline, Day 29, Day 30', 'description': 'Change from baseline at Day 29 and Day 30 of Skin pH Units assessed by pH-meter'}], 'secondaryOutcomes': [{'measure': 'Transepidermal Water Loss', 'timeFrame': 'baseline, Day 29, Day 30', 'description': 'Change from baseline at Day 29 and Day 30 of Transepidermal Water Loss (g/m2/h) assessed by Tewameter'}, {'measure': 'Skin Hydration', 'timeFrame': 'baseline, Day 29, Day 30', 'description': 'Change from baseline at Day 29 and Day 30 of Skin Hydration Arbitrary Units assessed by Corneometer'}, {'measure': 'Intercellular lipid lamellae lenght (nm ICLL/1000 nm2 ICS)', 'timeFrame': 'baseline, Day 29, Day 30', 'description': 'Change from baseline at Day 29 and Day 30 of stratum corneum assessed by transmission electron microscopy'}, {'measure': 'Lipid Analysis ((concentration of : Cholesterol (µg/slide), FFA (µg/slide), Ceramide EOS (µg/slide), Ceramide NP (µg/slide), Ceramide NH (µg/slide))', 'timeFrame': 'baseline, Day 29, Day 30', 'description': 'Change from baseline at Day 29 and Day 30 of corneocyte layer area assessed from the TEM data'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pH of the skin', 'SDS', 'Lipbarvis', 'TEWL', 'Skin hydration'], 'conditions': ['Aged Skin']}, 'descriptionModule': {'briefSummary': 'The aim of the study was to assess the long-term efficacy and barrier protection properties of two cosmetic products on the volar forearms of 20 elderly subjects after four weeks of treatment compared to two untreated test areas.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written Informed Consent to participate in the study\n* Willingness to actively participate in the study and to come to the scheduled visits\n* Female and male (at least 30% male subjects)\n* From 50 to 75 years of age, equally distributed\n\nExclusion Criteria:\n\n* Female subjects: Pregnancy or lactation\n* Drug addicts, alcoholics\n* AIDS or infectious hepatitis if known to the subjects\n* Conditions which exclude a participation or might influence the test reaction/ evaluation\n* Participation or being in the waiting period after participation in similar cosmetic and/or pharmaceutical studies\n* Active skin disease at the test area\n* One of the following serious illnesses that might require regular systemic medication: insulin-dependent diabetes\n* Moles, tattoos, scars, irritated skin, hairs, etc. at the test area that could influence the Investigation'}, 'identificationModule': {'nctId': 'NCT03629405', 'briefTitle': 'Assessment of the Efficacy and Barrier Protection of Two Cosmetic Products', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dr. August Wolff GmbH & Co. KG Arzneimittel'}, 'officialTitle': 'Assessment of the Long-Term Efficacy and Barrier Protection of Two Skin Care Products', 'orgStudyIdInfo': {'id': 'PH4G-04/2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'A - Negative control (untreated) for product C', 'description': 'On the forearms four test areas were located, which were labeled from A-D. Test area A contralateral to product C'}, {'type': 'NO_INTERVENTION', 'label': 'B - Negative control (untreated) for product D', 'description': 'On the forearms four test areas were located, which were labeled from A-D. Test area B contralateral to product D'}, {'type': 'EXPERIMENTAL', 'label': 'C - Cosmetic Product WO 3741 with pH 4', 'description': 'On the forearms four test areas were located, which were labeled from A-D. Test area C on the same arm like product D.', 'interventionNames': ['Other: C - pH 4 Cosmetic Product WO 3741']}, {'type': 'EXPERIMENTAL', 'label': 'D - Cosmetic Product WO 4081-1 with pH 5.8', 'description': 'On the forearms four test areas were located, which were labeled from A-D.', 'interventionNames': ['Other: D - pH 5.8 Cosmetic Product WO 4081-1']}], 'interventions': [{'name': 'C - pH 4 Cosmetic Product WO 3741', 'type': 'OTHER', 'description': 'Application of the product on the pre-defined skin area on the forearms twice daily for four weeks', 'armGroupLabels': ['C - Cosmetic Product WO 3741 with pH 4']}, {'name': 'D - pH 5.8 Cosmetic Product WO 4081-1', 'type': 'OTHER', 'description': 'Application of the product on the pre-defined skin area on the forearms twice daily for four weeks', 'armGroupLabels': ['D - Cosmetic Product WO 4081-1 with pH 5.8']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Schenefeld', 'country': 'Germany', 'facility': 'proDERM Institute for Applied Dermatological Research', 'geoPoint': {'lat': 54.04644, 'lon': 9.48146}}], 'overallOfficials': [{'name': 'Prof. Klaus-Peter Wilhelm, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'proDERM Institute for Applied Dermatological Research, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. August Wolff GmbH & Co. KG Arzneimittel', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'proDERM Institut für Angewandte Dermatologische Forschung GmbH', 'class': 'UNKNOWN'}, {'name': 'Microscopy Services Dähnhardt GmbH', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}