Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2026-03-18 @ 2:45 AM
Study NCT ID:
NCT00655512
Status:
COMPLETED
Last Update Posted:
2014-06-11
First Post:
2008-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Skin Thickness Under Treatment With Pimecrolimus 1% Cream, Hydrocortisonacetat 1% Cream, Betamethasonvalerat 0,1% Cream and Clobetasol-17-propionat 0,05% Cream Assessed by Optical Coherence Tomography (OCT) and 20-MHZ Ultrasound
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C117268', 'term': 'pimecrolimus'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-10', 'studyFirstSubmitDate': '2008-04-04', 'studyFirstSubmitQcDate': '2008-04-09', 'lastUpdatePostDateStruct': {'date': '2014-06-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'thickness of epidermis', 'timeFrame': '9 times in 4 weeks'}], 'secondaryOutcomes': [{'measure': 'atrophogenic effect assessed by dermaphot', 'timeFrame': '9 times in 4 weeks'}, {'measure': 'moisture of skin assessed by corneometer', 'timeFrame': '9 times in 4 weeks'}, {'measure': 'transpire of skin assessed by tewameter', 'timeFrame': '9 times in 4 weeks'}, {'measure': 'thickness of dermis', 'timeFrame': '9 times in 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pimecrolimus', 'hydrocortison', 'betamethasone', 'clobetasol-17-Propionat', 'Optical Coherence Tomography', 'skin healthy probands'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'to compare the atrophogenic potentials of pimecrolimus 1% cream, hydrocortisonacetat 1% cream, betamethasonvalerat 0,1% cream and clobetasol-17-Propionat 0,05% cream'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male and female probands age between 18-40 years\n* skin healthy\n* skintype I-III according to Fitzpatrick\n\nExclusion Criteria:\n\n* women of childbearing potential without adequate contraception\n* pregnant or breastfeeding\n* genetic defect of epidermal barrier\n* external or systemic treatment with drugs, which probably have an effect to the thickness of skin or to the production of teleangiektasien within the last 6 month before study entry\n* skin disease, which hinder the evaluation with OCT, ultrasound or dermaphot\n* UV treatment within the last 4 weeks before study entry\n* participation to another clinical trial within the last 30 days before study entry\n* allergy against pimecrolimus or hydrocortison or betamethasonvalerat or Clobetasol-17-propionat\n* severe systemic diseases; ongoing immunosuppressive treatment\n* planned vaccination should realize before study entry or 28 days after end of treatment'}, 'identificationModule': {'nctId': 'NCT00655512', 'acronym': 'OCT', 'briefTitle': 'Comparison of Skin Thickness Under Treatment With Pimecrolimus 1% Cream, Hydrocortisonacetat 1% Cream, Betamethasonvalerat 0,1% Cream and Clobetasol-17-propionat 0,05% Cream Assessed by Optical Coherence Tomography (OCT) and 20-MHZ Ultrasound', 'organization': {'class': 'OTHER', 'fullName': 'Technische Universität Dresden'}, 'officialTitle': 'Comparison of Skin Thickness Under Treatment With Pimecrolimus 1% Cream (Elidel® 1% Cream), Hydrocortisonacetat 1% Cream (Hydrogalen® Cream), Betamethasonvalerat 0,1% Cream (Betagalen® Cream) and Clobetasol-17-propionat 0,05% Cream (Clobegalen® Cream) Assessed by Optical Coherence Tomography (OCT) and 20-MHZ Ultrasound - a Single Blind, Placebo-controlled, Randomized, Monocenter Clinical Trial', 'orgStudyIdInfo': {'id': 'TUD-OCT011-023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'interventionNames': ['Drug: hydrocortisonacetat 1% cream', 'Drug: betamethasonvalerat 0,1% cream', 'Drug: clobetasol-17-propionat 0,05% cream']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: pimecrolimus 1% cream', 'Drug: betamethasonvalerat 0,1% cream', 'Drug: clobetasol-17-propionat 0,05% cream']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'interventionNames': ['Drug: pimecrolimus 1% cream', 'Drug: hydrocortisonacetat 1% cream', 'Drug: clobetasol-17-propionat 0,05% cream']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4', 'interventionNames': ['Drug: pimecrolimus 1% cream', 'Drug: hydrocortisonacetat 1% cream', 'Drug: betamethasonvalerat 0,1% cream']}, {'type': 'PLACEBO_COMPARATOR', 'label': '5', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'pimecrolimus 1% cream', 'type': 'DRUG', 'otherNames': ['Elidel 1% cream'], 'description': 'twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks', 'armGroupLabels': ['2', '3', '4']}, {'name': 'hydrocortisonacetat 1% cream', 'type': 'DRUG', 'otherNames': ['Hydrogalen cream'], 'description': 'twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks', 'armGroupLabels': ['1', '3', '4']}, {'name': 'betamethasonvalerat 0,1% cream', 'type': 'DRUG', 'otherNames': ['Betagalen cream'], 'description': 'twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks', 'armGroupLabels': ['1', '2', '4']}, {'name': 'clobetasol-17-propionat 0,05% cream', 'type': 'DRUG', 'otherNames': ['Clobegalen cream'], 'description': 'twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks', 'armGroupLabels': ['1', '2', '3']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks', 'armGroupLabels': ['5']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dresden', 'country': 'Germany', 'facility': 'Department of Dermatology, Medical Faculty, TU Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}], 'overallOfficials': [{'name': 'Roland Aschoff, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Dermatology, Medical Faculty, Technical University Dresden, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technische Universität Dresden', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}