Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-02-25 @ 10:12 PM
Study NCT ID:
NCT03625167
Status:
COMPLETED
Last Update Posted:
2025-02-19
First Post:
2018-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of a Basic Skin Care Product on the Structural Strength of the Skin
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010577', 'term': 'Petrolatum'}], 'ancestors': [{'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'monira.el-genedy@charite.de', 'phone': '+49 30 450 529 434', 'title': 'Monira El Genedy-Kalyoncu', 'organization': 'Charité - Universitätsmedizin Berlin'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected for each participant throughout their time of participation (up to 8 weeks). No Adverse Events occurred during the trial.', 'description': 'No Adverse Events occurred during the trial', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention: Treatment With Petrolatum', 'description': 'In each healthy volunteer, one of the two forearms is randomly assigned to the intervention. This forearm is treated with petrolatum for 4 respectively 8 weeks. Petrolatum is applied twice daily to the intervention arm.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control: No Treatment', 'description': 'The control forearm will remain untreated throughout the study.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Blistering Time (Full Blister)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'units': 'Volar forearm', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention: Treatment With Petrolatum', 'description': 'Petrolatum was applied twice daily to the randomized volar forearm'}, {'id': 'OG001', 'title': 'Control: No Treatment', 'description': 'The control forearm remained untreated throughout the study'}], 'classes': [{'title': 'Blistering Time (Full Blister) Day 28±2', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000', 'lowerLimit': '53', 'upperLimit': '94'}, {'value': '54', 'groupId': 'OG001', 'lowerLimit': '45', 'upperLimit': '71'}]}]}, {'title': 'Blistering Time (Full Blister) Day 56±2', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000', 'lowerLimit': '49', 'upperLimit': '75'}, {'value': '62', 'groupId': 'OG001', 'lowerLimit': '42', 'upperLimit': '73'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 28±2, Day 56±2', 'description': 'Duration from the start of suction pressure to the development of a full blister (measured in minutes)', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Volar forearm', 'denomUnitsSelected': 'Volar forearm'}, {'type': 'PRIMARY', 'title': 'Blistering Time (First Vesicles)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'units': 'Volar forearm', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention: Treatment With Petrolatum', 'description': 'Petrolatum was applied twice daily to the randomized volar forearm'}, {'id': 'OG001', 'title': 'Control: No Treatment', 'description': 'The control forearm remained untreated throughout the study'}], 'classes': [{'title': 'Blistering Time (First Vesicles) Day 28±2', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '69'}, {'value': '39', 'groupId': 'OG001', 'lowerLimit': '25', 'upperLimit': '76'}]}]}, {'title': 'Blistering Time (First Vesicles) Day 56±2', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000', 'lowerLimit': '32', 'upperLimit': '69'}, {'value': '27', 'groupId': 'OG001', 'lowerLimit': '24', 'upperLimit': '60'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 28±2, Day 56±2', 'description': 'Duration from the start of suction pressure to the development of first macroscopically visible vesicles (measured in minutes)', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Volar forearm', 'denomUnitsSelected': 'Volar forearm'}, {'type': 'SECONDARY', 'title': 'Epidermal Thickness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'units': 'Volar forearm', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention: Treatment With Petrolatum', 'description': 'Petrolatum was applied twice daily to the randomized volar forearm'}, {'id': 'OG001', 'title': 'Control: No Treatment', 'description': 'The control forearm remained untreated throughout the study'}], 'classes': [{'title': 'Epidermal Thickness (Baseline)', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000', 'lowerLimit': '65', 'upperLimit': '86'}, {'value': '68', 'groupId': 'OG001', 'lowerLimit': '63', 'upperLimit': '80'}]}]}, {'title': 'Epidermal Thickness (Day 28±2)', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000', 'lowerLimit': '60', 'upperLimit': '84'}, {'value': '72', 'groupId': 'OG001', 'lowerLimit': '63', 'upperLimit': '79'}]}]}, {'title': 'Epidermal Thickness (Day 56±2)', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000', 'lowerLimit': '62', 'upperLimit': '79'}, {'value': '71', 'groupId': 'OG001', 'lowerLimit': '65', 'upperLimit': '77'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Day 28±2, Day 56±2', 'description': 'Optical coherence tomography (OCT) will be used to quantitatively measure changes of the epidermal thickness on the volar forearm', 'unitOfMeasure': 'micrometres (μm)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Volar forearm', 'denomUnitsSelected': 'Volar forearm'}, {'type': 'SECONDARY', 'title': 'Epidermal Hydratation: Stratum Corneum Hydration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'units': 'Volar forearm', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention: Treatment With Petrolatum', 'description': 'Petrolatum was applied twice daily to the randomized volar forearm'}, {'id': 'OG001', 'title': 'Control: No Treatment', 'description': 'The control forearm remained untreated throughout the study'}], 'classes': [{'title': 'Stratum corneum hydration (AU) Baseline', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000', 'lowerLimit': '35', 'upperLimit': '49'}, {'value': '40', 'groupId': 'OG001', 'lowerLimit': '35', 'upperLimit': '47'}]}]}, {'title': 'Stratum corneum hydration (AU) Day 14±1', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000', 'lowerLimit': '40', 'upperLimit': '46'}, {'value': '36', 'groupId': 'OG001', 'lowerLimit': '34', 'upperLimit': '40'}]}]}, {'title': 'Stratum corneum hydration (AU) Day 28±2', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000', 'lowerLimit': '36', 'upperLimit': '44'}, {'value': '36', 'groupId': 'OG001', 'lowerLimit': '33', 'upperLimit': '39'}]}]}, {'title': 'Stratum corneum hydration (AU) Day 42±2', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000', 'lowerLimit': '35', 'upperLimit': '43'}, {'value': '36', 'groupId': 'OG001', 'lowerLimit': '33', 'upperLimit': '37'}]}]}, {'title': 'Stratum corneum hydration (AU) Day 56±2', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000', 'lowerLimit': '33', 'upperLimit': '48'}, {'value': '35', 'groupId': 'OG001', 'lowerLimit': '32', 'upperLimit': '41'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Day 14±1, Day 28±2, Day 42±2, Day 56±2', 'description': 'Stratum corneum hydration (SCH) was measured with Corneometer® CM 825 (Courage \\& Khazaka electronic GmbH, Cologne, Germany) and expressed in arbitrary units (AU) (range 0-120 AU) on the volar forearm. Lower values represent reduced skin hydration in the upper skin layer.', 'unitOfMeasure': 'Arbitrary Units', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Volar forearm', 'denomUnitsSelected': 'Volar forearm'}, {'type': 'SECONDARY', 'title': 'Epidermal Hydratation: Epidermal Moisture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'units': 'Volar forearm', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention: Treatment With Petrolatum', 'description': 'Petrolatum was applied twice daily to the randomized volar forearm'}, {'id': 'OG001', 'title': 'Control: No Treatment', 'description': 'The control forearm remained untreated throughout the study'}], 'classes': [{'title': 'Epidermal Moisture (%) Baseline', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000', 'lowerLimit': '39', 'upperLimit': '54'}, {'value': '46', 'groupId': 'OG001', 'lowerLimit': '38', 'upperLimit': '54'}]}]}, {'title': 'Epidermal Moisture (%) Day 14±1', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000', 'lowerLimit': '42', 'upperLimit': '48'}, {'value': '41', 'groupId': 'OG001', 'lowerLimit': '37', 'upperLimit': '46'}]}]}, {'title': 'Epidermal Moisture (%) Day 28±2', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000', 'lowerLimit': '42', 'upperLimit': '49'}, {'value': '41', 'groupId': 'OG001', 'lowerLimit': '38', 'upperLimit': '48'}]}]}, {'title': 'Epidermal Moisture (%) Day 42±2', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000', 'lowerLimit': '42', 'upperLimit': '58'}, {'value': '42', 'groupId': 'OG001', 'lowerLimit': '38', 'upperLimit': '50'}]}]}, {'title': 'Epidermal Moisture (%) Day 56±2', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000', 'lowerLimit': '42', 'upperLimit': '50'}, {'value': '42', 'groupId': 'OG001', 'lowerLimit': '40', 'upperLimit': '43'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Day 14±1, Day 28±2, Day 42±2, Day 56±2', 'description': 'Epidermal Moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %).', 'unitOfMeasure': 'percentage of tissue water', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Volar forearm', 'denomUnitsSelected': 'Volar forearm'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Split-Body-Design on Both Forearms. Intervention: Treatment With Petrolatum; Control: No Treatment', 'description': 'In each healthy volunteer, one of the two forearms is randomly assigned to the intervention. This forearm is treated with petrolatum for 4 respectively 8 weeks.\n\nTreatment with petrolatum: Petrolatum is applied twice daily to the intervention arm.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '34', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '24', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '10', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}], 'typeUnitsAnalyzed': 'Forearms'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}, {'units': 'Volar forearm', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Split-Body-Design on Both Forearms. Intervention: Treatment With Petrolatum; Control: No Treatment', 'description': 'In each healthy volunteer, one of the two forearms is randomly assigned to the intervention. This forearm is treated with petrolatum for 4 respectively 8 weeks.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Age', 'categories': [{'measurements': [{'value': '70.3', 'spread': '2.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '26.0', 'spread': '2.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Skin phototype (Fitzpatrick scale)', 'classes': [{'categories': [{'title': 'Type II', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Type III', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Skin phototype of participants was classified according the Fitzpatrick classification ranging from phototype I to VI.\n\nFitzpatrick Type:\n\nI: Always burns, never tans (pale skin); II: Usually burns, minimal tanning; III: Occasionally burns, usually tans uniformly; IV: Rarely burns, always tans well; V: Very rarely burns, tans very easily; VI: Never burns, always tans (dark brown/black skin)', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Body temperature', 'classes': [{'categories': [{'measurements': [{'value': '36.3', 'spread': '0.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'degree Celsius', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Blood pressure', 'classes': [{'title': 'Systolic', 'categories': [{'measurements': [{'value': '127', 'spread': '16', 'groupId': 'BG000'}]}]}, {'title': 'Diastolic', 'categories': [{'measurements': [{'value': '83', 'spread': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}], 'typeUnitsAnalyzed': 'Volar forearm'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-28', 'size': 1171247, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-08-06T03:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-18', 'studyFirstSubmitDate': '2018-08-01', 'resultsFirstSubmitDate': '2021-08-06', 'studyFirstSubmitQcDate': '2018-08-06', 'lastUpdatePostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-18', 'studyFirstPostDateStruct': {'date': '2018-08-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blistering Time (Full Blister)', 'timeFrame': 'Day 28±2, Day 56±2', 'description': 'Duration from the start of suction pressure to the development of a full blister (measured in minutes)'}, {'measure': 'Blistering Time (First Vesicles)', 'timeFrame': 'Day 28±2, Day 56±2', 'description': 'Duration from the start of suction pressure to the development of first macroscopically visible vesicles (measured in minutes)'}], 'secondaryOutcomes': [{'measure': 'Epidermal Thickness', 'timeFrame': 'Baseline, Day 28±2, Day 56±2', 'description': 'Optical coherence tomography (OCT) will be used to quantitatively measure changes of the epidermal thickness on the volar forearm'}, {'measure': 'Epidermal Hydratation: Stratum Corneum Hydration', 'timeFrame': 'Baseline, Day 14±1, Day 28±2, Day 42±2, Day 56±2', 'description': 'Stratum corneum hydration (SCH) was measured with Corneometer® CM 825 (Courage \\& Khazaka electronic GmbH, Cologne, Germany) and expressed in arbitrary units (AU) (range 0-120 AU) on the volar forearm. Lower values represent reduced skin hydration in the upper skin layer.'}, {'measure': 'Epidermal Hydratation: Epidermal Moisture', 'timeFrame': 'Baseline, Day 14±1, Day 28±2, Day 42±2, Day 56±2', 'description': 'Epidermal Moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['skin ageing', 'suction blister', 'dermo-epidermal junction'], 'conditions': ['Healthy Skin']}, 'referencesModule': {'references': [{'pmid': '34121334', 'type': 'RESULT', 'citation': 'El Genedy-Kalyoncu M, Richter C, Surber C, Blume-Peytavi U, Kottner J. The effect of a basic skin care product on the structural strength of the dermo-epidermal junction: An exploratory, randomised, controlled split-body trial. Int Wound J. 2022 Feb;19(2):426-435. doi: 10.1111/iwj.13643. Epub 2021 Jun 13.'}]}, 'descriptionModule': {'briefSummary': 'The main aim of this study is to investigate in a suction blister model, whether the use of a basic skin care formulation increases the mechanical integrity/adhesion of the dermo-epidermal junction.', 'detailedDescription': 'The process of aging involves numerous structural and functional changes also affecting the skin. The skin fulfills a variety of protective and regulatory functions. Compared to other organs, the skin is constantly exposed to harmful environmental influences. Besides intrinsic factors these external factors may accelerate skin aging. Due to its ageing-related loss of functional capacity the skin becomes susceptible to develop adverse skin conditions and dermatological diseases (e.g. skin dryness, fungal infections). Especially old aged, care depended, and severely ill individuals are at high risk for developing severe skin injuries and wounds (e.g. decubitus, skin tears) with high social and economic impact. Empirical evidence indicates that the reduced adhesion of the dermal-epidermal junction is a major pathophysiological predictor for these types of injuries.\n\nThe suction blister model is an artificial and controlled technique for dermal-epidermal separation along the dermo-epidermal junction (DEJ). Empirical evidence suggests that the time of the dermal-epidermal separation (blistering time) is a measure of the dermo-epidermal adhesion. It has been proposed that the blistering time might be a clinically relevant parameter reflecting the mechanical integrity/stability of the dermo-epidermal junction.\n\nClinical practice guidelines recommend the use of topical skin care products to reduce the risk for pressure ulcer and skin tear development. However, the underlying working mechanisms of most basic skin care products are poorly understood. It is known that topically applied skin care products exhibit physical and chemical effects on and in the uppermost skin layers (e.g. the stratum corneum). Despite a few well known active ingredients (e.g. retinoids, vitamin C) exhibiting effects in the dermis, a particular skin protective effect of the vast majority of daily basic skin care applications on these deeper skin layers is unknown. The primary objective of this study is to test, whether the use of a basic skin care formulation increases the mechanical integrity/adhesion of the dermo-epidermal junction.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers and/or with stable chronic condition (e.g. controlled hypertension)\n* Female,\n* 65 to 85 years,\n* Caucasian,\n* Phototype I to III according to the Fitzpatrick classification,\n* Body Mass Index between 20 and 28 kg/m2,\n* Non-smoker of at least one year,\n* Absence of skin diseases or scars in the skin area of interest,\n* Absence of tattoos in the skin area of interest,\n* Able to give written informed consent,\n* Willing and able to fulfill the study requirements\n\nExclusion Criteria:\n\n* Known or suspected defect of healing,\n* Diabetes mellitus\n* Any acute or chronic pathology that may interfere with the trial conduct, from investigator point of view,\n* Acute or chronic wounds in the skin area of interest,\n* Any skin affection which may interfere with the trial assessment, like urticaria,, psoriasis or scar on investigational areas,\n* Medical history of skin cancer,\n* History or establishment of diabetes or pre-diabetes,\n* Any hyper-sensibility to one of the compounds of the investigational product,\n* Any regular treatment which may affect the blood coagulation and hemostasis (anticoagulant medications, NSAID, etc.) before the suction blister induction (Visit 3 and Visit 5), one NSAID to treat headache within four days is allowed\n* Any physical treatment (like laser or surgery) on the arms within the last 6 months,\n* Use of topical or systemic treatment on the investigational areas within the past 4 weeks (topical hyaluronan, anti-inflammatory drugs, corticoids, retinoids, vitamin C, etc.) that would interfere with assessment and/or investigational treatments,\n* Allergy to band-aid or to metals (such as nickel),\n* UV sessions or strong sun exposure of the arms during the study period,\n* Subject who cannot be contacted easily in case of necessity,\n* Current participation in any other clinical study'}, 'identificationModule': {'nctId': 'NCT03625167', 'briefTitle': 'Effect of a Basic Skin Care Product on the Structural Strength of the Skin', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'An Exploratory Randomized Controlled Study to Evaluate the Effect of a Basic Skin Care Product on the Structural Strength of the Dermo-epidermal Junction', 'orgStudyIdInfo': {'id': 'CRC-SP-A31'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment with petrolatum', 'description': 'In each healthy volunteer, one of the two forearms is randomly assigned to the intervention. This forearm is treated with petrolatum for 4 respectively 8 weeks.', 'interventionNames': ['Other: Treatment with petrolatum']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'The control forearm will remain untreated throughout the study.'}], 'interventions': [{'name': 'Treatment with petrolatum', 'type': 'OTHER', 'description': 'Petrolatum is applied twice daily to the intervention arm.', 'armGroupLabels': ['Treatment with petrolatum']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Clinical Research Center for Hair and Skin Science, Department of Dermatology and Allergy, Charite University Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Jan Kottner, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prof. Dr. Jan Kottner', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of the Institute of Clinical Nursing Science', 'investigatorFullName': 'Prof. Dr. Jan Kottner', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}