Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-01-02 @ 3:06 AM
Study NCT ID:
NCT02818257
Status:
COMPLETED
Last Update Posted:
2019-02-01
First Post:
2016-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Investigation Exploring Adhesive Materials and Their Ability to Handle Moisture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-10-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-31', 'studyFirstSubmitDate': '2016-06-21', 'studyFirstSubmitQcDate': '2016-06-28', 'lastUpdatePostDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peel force used to removed adhesive', 'timeFrame': '60 min', 'description': 'The three strips applied to skin that has received the same treatment (either buffer 1, buffer 2 or dry) are removed at three different time points (max 60 min) and the peel force is measured.\n\nPeel force (90 degree angle from skin) The tensile tester was mounted on a tripod under which the subject was lying. In this way the tensile tester measures the force (Newton), which was needed to remove the adhesive from the skin with a constant speed and with a mean angel of 90°'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The aim is to investigate the impact that water absorption properties in adhesives has on adhesion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have given written informed consent\n* Be at least 18 years of age and have full legal capacity\n* Have intact skin on the area used in the investigation\n\nExclusion Criteria:\n\n* Currently receiving or have within the past 2 month received radio- and/or chemotherapy\n* Currently receiving or have within the past month received topical steroid treatment in the abdominal skin area or systemic steroid (tablet/injection) treatment.\n* Are pregnant or breastfeeding\n* Having dermatological problems in the abdominal area (assessed by investigator)\n* Participate in other clinical investigations or have previously participated in this investigation'}, 'identificationModule': {'nctId': 'NCT02818257', 'briefTitle': 'An Investigation Exploring Adhesive Materials and Their Ability to Handle Moisture', 'organization': {'class': 'INDUSTRY', 'fullName': 'Coloplast A/S'}, 'officialTitle': 'An Investigation Exploring Adhesive Materials and Their Ability to Handle Moisture', 'orgStudyIdInfo': {'id': 'CP263'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Strip A (wet)', 'description': 'Six strips of Strip A are applied on skin wetted with two different buffers (3 strips each)', 'interventionNames': ['Other: Strip A']}, {'type': 'EXPERIMENTAL', 'label': 'Strip A (dry)', 'description': 'Six strips of Strip A are applied on skin that is dry (3 strips) and wetted with buffer (3 strips)', 'interventionNames': ['Other: Strip A']}, {'type': 'EXPERIMENTAL', 'label': 'Strip B (wet)', 'description': 'Six strips of Strip B are applied on skin wetted with two different buffers (3 strips each)', 'interventionNames': ['Other: Strip B']}, {'type': 'EXPERIMENTAL', 'label': 'Strip B (dry)', 'description': 'Six strips of Strip B are applied on skin that is dry (3 strips) and wetted with buffer (3 strips)', 'interventionNames': ['Other: Strip B']}, {'type': 'EXPERIMENTAL', 'label': 'Strip C (wet)', 'description': 'Six strips of Strip C are applied on skin wetted with two different buffers (3 strips each)', 'interventionNames': ['Other: Strip C']}, {'type': 'EXPERIMENTAL', 'label': 'Strip C (dry)', 'description': 'Six strips of Strip C are applied on skin that is either dry (3 strips) or wetted with buffer (3 strips)', 'interventionNames': ['Other: Strip C']}], 'interventions': [{'name': 'Strip A', 'type': 'OTHER', 'description': 'Adhesive strip A', 'armGroupLabels': ['Strip A (dry)', 'Strip A (wet)']}, {'name': 'Strip B', 'type': 'OTHER', 'description': 'Adhesive strip B', 'armGroupLabels': ['Strip B (dry)', 'Strip B (wet)']}, {'name': 'Strip C', 'type': 'OTHER', 'description': 'Adhesive strip C', 'armGroupLabels': ['Strip C (dry)', 'Strip C (wet)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3050', 'city': 'Humlebæk', 'country': 'Denmark', 'facility': 'Coloplast', 'geoPoint': {'lat': 55.9618, 'lon': 12.5341}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coloplast A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}