Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT06044532
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2023-08-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SKAMo-1: Characterization of the Upper Layers of Skin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-04-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-13', 'studyFirstSubmitDate': '2023-08-07', 'studyFirstSubmitQcDate': '2023-09-13', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of skin hydration on the dorsum of the forearm after two and a half hours of wearing the sham device.', 'timeFrame': 'Visit 1,Day 0, before and after two and a half hours of wearing the sham device', 'description': 'Hydration is measured with a capacitance method, expressed as arbitrary units (dielectric value)'}], 'secondaryOutcomes': [{'measure': 'Change of skin elasticity after the wearing the sham device', 'timeFrame': 'Visit 1,Day 0, before and after two and a half hours of wearing the sham device', 'description': 'elasticity (suction method) expressed as penetration depth in mm/time'}, {'measure': 'Change of transepidermal water loss after the wearing the sham device', 'timeFrame': 'Visit 1,Day 0, before and after two and a half hours of wearing the sham device', 'description': 'transepidermal water loss (the density gradient of the water evaporation) expressed as the evaporation rate in g/h/m2'}, {'measure': 'Change of thickness of the stratum corneum after the wearing the sham device', 'timeFrame': 'Visit 1,Day 0, before and after two and a half hours of wearing the sham device', 'description': 'thickness of the stratum corneum (LC-OCT method) expressed as mm'}, {'measure': 'Change of skin temperature after the wearing the sham device', 'timeFrame': 'Visit 1,Day 0, before and after two and a half hours of wearing the sham device', 'description': 'skin temperature (infrared thermography) expressed as Celsius,'}, {'measure': 'Change of skin blood flux after the wearing the sham device', 'timeFrame': 'Visit 1,Day 0, before and after two and a half hours of wearing the sham device', 'description': 'skin blood flux (LSCI) expressed as an arbitrary unit,'}, {'measure': 'Change of skin hydration after skin cleaning', 'timeFrame': 'Visit 1, Day 0, in 30 minutes, measures taken before and after skin cleaning', 'description': 'expressed as previously described'}, {'measure': 'Change of skin elasticity after skin cleaning', 'timeFrame': 'Visit 1, Day 0, in 30 minutes, measures taken before and after skin cleaning', 'description': 'expressed as previously described'}, {'measure': 'Change of transepidermal water loss after skin cleaning', 'timeFrame': 'Visit 1, Day 0, in 30 minutes, measures taken before and after skin cleaning', 'description': 'expressed as previously described'}, {'measure': 'Change of thickness of the stratum corneum after skin cleaning', 'timeFrame': 'Visit 1, Day 0, in 30 minutes, measures taken before and after skin cleaning', 'description': 'expressed as previously described'}, {'measure': 'Change of skin temperature after skin cleaning', 'timeFrame': 'Visit 1, Day 0, in 30 minutes, measures taken before and after skin cleaning', 'description': 'expressed as previously described'}, {'measure': 'Change of skin blood flux after skin cleaning', 'timeFrame': 'Visit 1, Day 0, in 30 minutes, measures taken before and after skin cleaning', 'description': 'expressed as previously described'}, {'measure': 'Change of skin hydration after skin sanding', 'timeFrame': 'Visit 1, Day 0, in 30 minutes, measures taken before and after skin sanding', 'description': 'expressed as previously described'}, {'measure': 'Change of skin elasticity after skin sanding', 'timeFrame': 'Visit 1, Day 0, in 30 minutes, measures taken before and after skin sanding', 'description': 'expressed as previously described'}, {'measure': 'Change of transepidermal water loss after skin sanding', 'timeFrame': 'Visit 1, Day 0, in 30 minutes, measures taken before and after skin sanding', 'description': 'expressed as previously described'}, {'measure': 'Change of thickness of the stratum corneum after skin sanding', 'timeFrame': 'Visit 1, Day 0, in 30 minutes, measures taken before and after skin sanding', 'description': 'expressed as previously described'}, {'measure': 'Change of skin temperature after skin sanding', 'timeFrame': 'Visit 1, Day 0, in 30 minutes, measures taken before and after skin sanding', 'description': 'expressed as previously described'}, {'measure': 'Change of skin blood flux after skin sanding', 'timeFrame': 'Visit 1, Day 0, in 30 minutes, measures taken before and after skin sanding', 'description': 'expressed as previously described'}, {'measure': 'Change of skin hydration after local heating', 'timeFrame': 'Visit 2, Day 7 (+/-6 days), before and after local heating (40 minutes local thermal heating between 33 to 43°C with probes PF457)', 'description': 'expressed as previously described'}, {'measure': 'Change of skin elasticity after local heating', 'timeFrame': 'Visit 2, Day 7 (+/-6 days), before and after local heating (40 minutes local thermal heating between 33 to 43°C with probes PF457)', 'description': 'expressed as previously described'}, {'measure': 'Change of transepidermal water loss after local heating', 'timeFrame': 'Visit 2, Day 7 (+/-6 days) before and after local heating (40 minutes local thermal heating between 33 to 43°C with probes PF457)', 'description': 'expressed as previously described'}, {'measure': 'Change of thickness of the stratum corneum after local heating', 'timeFrame': 'Visit 2, Day 7 (+/-6 days) before and after local heating (40 minutes local thermal heating between 33 to 43°C with probes PF457)', 'description': 'expressed as previously described'}, {'measure': 'Change of skin temperature after local heating', 'timeFrame': 'Visit 2, Day 7 (+/-6 days) before and after local heating (40 minutes local thermal heating between 33 to 43°C with probes PF457)', 'description': 'expressed as previously described'}, {'measure': 'Change of skin blood flux after local heating', 'timeFrame': 'Visit 2, Day 7 (+/-6 days) before and after local heating (40 minutes local thermal heating between 33 to 43°C with probes PF457)', 'description': 'expressed as previously described'}, {'measure': 'Change of skin hydration induced by oral glycemia tolerance test', 'timeFrame': 'Visit 2, Day 7 (+/-6 days), before and during oral glycemia tolerance test (every 15 minutes for 2 hours)', 'description': 'expressed as previously described'}, {'measure': 'Change of skin elasticity induced by oral glycemia tolerance test', 'timeFrame': 'Visit 2, Day 7 (+/-6 days), before and during oral glycemia tolerance test (every 15 minutes for 2 hours)', 'description': 'expressed as previously described'}, {'measure': 'Change of transepidermal water loss induced by oral glycemia tolerance test', 'timeFrame': 'Visit 2, Day 7 (+/-6 days), before and during oral glycemia tolerance test (every 15 minutes for 2 hours)', 'description': 'expressed as previously described'}, {'measure': 'Change of thickness of the stratum corneum induced by oral glycemia tolerance test', 'timeFrame': 'Visit 2, Day 7 (+/-6 days), before and during oral glycemia tolerance test (every 15 minutes for 2 hours)', 'description': 'expressed as previously described'}, {'measure': 'Change of skin temperature induced by oral glycemia tolerance test', 'timeFrame': 'Visit 2, Day 7 (+/-6 days), before and during oral glycemia tolerance test (every 15 minutes for 2 hours)', 'description': 'expressed as previously described'}, {'measure': 'Change of skin blood flux induced by oral glycemia tolerance test', 'timeFrame': 'Visit 2, Day 7 (+/-6 days), before and during oral glycemia tolerance test (every 15 minutes for 2 hours)', 'description': 'expressed as previously described'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'Diabetes is a frequent disease characterized by chronic hyperglycemia, and its prevalence is increasing worldwide. Historically, patients with diabetes were required to monitor capillary blood glucose concentration up to several times a day through fingertip sampling.\n\nRecently marketed devices now allow measurements of interstitial fluid blood glucose continuously, thus limiting pain associated with sampling. However, they are still invasive and have to be changed every 14 days.\n\nTherefore, to optimize continuous glycemia monitoring while avoiding pain, discomfort, and the risk of infection, non-invasive methods are needed. Among the different strategies being developed, optical wearable sensors with specific signal processing are a promising option. The sensors detecting this optical signal will be included in a device. Yet, wearing a device may slightly modify several properties of the skin, such as its humidity and thermal regulation, and subsequently have an impact on the measured optical signal. Therefore, it is important to better understand how a device affects these characteristics to include these parameters in the future device algorithms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged ≥ 18 years and ≤ 60 years\n* Signed informed consent\n* Person who is affiliated to a social security scheme or who is beneficiary of such a scheme\n\nExclusion Criteria:\n\n* Body mass index (BMI) \\> 30 kg/m2\n* Any acute or chronic disease with vascular impact\n* Any cutaneous disease on sites implicated in the study (dorsum of the forearm)\n* Allergy to one of the material used in the sham device and during the procedure of the study\n* The persons mentioned in articles L1121-5 to L1121-8 of the public health code may not be included in this research\n* Subject who would receive more than 4500 euros in compensation due to his or her participation in other research involving the human person in the 12 months preceding this study'}, 'identificationModule': {'nctId': 'NCT06044532', 'briefTitle': 'SKAMo-1: Characterization of the Upper Layers of Skin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eclypia'}, 'officialTitle': 'SKAMo-1: Characterization of the Upper Layers of Skin', 'orgStudyIdInfo': {'id': '2022-A02578-35'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Skin characterization', 'interventionNames': ['Other: Experimental']}], 'interventions': [{'name': 'Experimental', 'type': 'OTHER', 'description': 'At the first visit, effects of skin preparations (cleaning or sanding) on skin parameters and wearing a sham device will be evaluated. At the second visit the effect on skin parameters of a local heating and an OGTT will be evaluated.', 'armGroupLabels': ['Skin characterization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHU Grenoble Alpes', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eclypia', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}