Ignite Creation Date:
2025-12-24 @ 3:49 PM
Ignite Modification Date:
2025-12-25 @ 6:50 PM
Study NCT ID:
NCT00779792
Status:
UNKNOWN
Last Update Posted:
2008-10-24
First Post:
2008-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Glycerol, Two Topical Steroids, and a Topical Immune Modulator Against Skin Irritation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003877', 'term': 'Dermatitis, Contact'}, {'id': 'D009783', 'term': 'Dermatitis, Occupational'}, {'id': 'D017453', 'term': 'Dermatitis, Irritant'}], 'ancestors': [{'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D009784', 'term': 'Occupational Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002990', 'term': 'Clobetasol'}, {'id': 'D014222', 'term': 'Triamcinolone Acetonide'}, {'id': 'D016559', 'term': 'Tacrolimus'}, {'id': 'D005990', 'term': 'Glycerol'}], 'ancestors': [{'id': 'D001623', 'term': 'Betamethasone'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D014221', 'term': 'Triamcinolone'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000073999', 'term': 'Triose Sugar Alcohols'}, {'id': 'D013402', 'term': 'Sugar Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2008-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-10-23', 'studyFirstSubmitDate': '2008-10-23', 'studyFirstSubmitQcDate': '2008-10-23', 'lastUpdatePostDateStruct': {'date': '2008-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'level of skin irritation as determined by visual reading, skin redness (color measurement), skin barrier integrity (transepidermal water loss measurement) and skin hydration (capacitance measurement)', 'timeFrame': 'End of treatment and summary measure (Area under the curve) of consecutive measurements at visit every other day for 10 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Irritant contact dermatitis', 'experimental contact dermatitis', 'treatment', 'efficacy', 'topical steroids', 'topical immune modulators', 'glycerol'], 'conditions': ['Dermatitis, Contact', 'Dermatitis, Occupational']}, 'referencesModule': {'references': [{'pmid': '17156893', 'type': 'BACKGROUND', 'citation': 'Andersen F, Hedegaard K, Petersen TK, Bindslev-Jensen C, Fullerton A, Andersen KE. Comparison of the effect of glycerol and triamcinolone acetonide on cumulative skin irritation in a randomized trial. J Am Acad Dermatol. 2007 Feb;56(2):228-35. doi: 10.1016/j.jaad.2006.08.063. Epub 2006 Dec 6.'}, {'pmid': '18416762', 'type': 'BACKGROUND', 'citation': 'Schliemann S, Kelterer D, Bauer A, John SM, Skudlik C, Schindera I, Wehrmann W, Elsner P. Tacrolimus ointment in the treatment of occupationally induced chronic hand dermatitis. Contact Dermatitis. 2008 May;58(5):299-306. doi: 10.1111/j.1600-0536.2007.01314.x.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy of glycerol ointment, triamcinolone acetonide ointment, clobetasol ointment and tacrolimus ointment on irritated skin in a cumulative skin irritation test model using healthy volunteers.', 'detailedDescription': 'Irritant contact dermatitis (ICD) is a frequent cause of hand eczema and occupational skin disease. One way to study ICD is to expose healthy volunteer skin to chemicals and evaluate the skin response. Because different chemicals act differently on the skin, the use of different skin irritants may provide more information than relying on one irritant only. In this study the two commonly used irritants sodium lauryl sulphate and nonanoic acid are exposed to the skin in a cumulative wash test. Treatment of ICD has classically involved topical steroids and/or emollients. However, the outcome is variable with some patients being very refractory to this regimen. This study was designed to investigate the relative efficacy of the steroids triamcinolone acetonide and clobetasol, the topical immune modulator tacrolimus, a 20% Glycerol ointment compared with an inert ointment vehicle on experimentally induced irritated skin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* caucasian\n* normal skin on both volar forearms\n* oral and written informed consent\n\nExclusion Criteria:\n\n* pregnant, lactating women\n* no safe anticonceptive method used\n* intake of systemic immunosuppressants (e.g. prednisolone)\n* endocrine, immune, or liver disorders\n* known allergy towards drugs applied to the skin'}, 'identificationModule': {'nctId': 'NCT00779792', 'acronym': 'WA+TR_1', 'briefTitle': 'Efficacy of Glycerol, Two Topical Steroids, and a Topical Immune Modulator Against Skin Irritation', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Comparison of Efficacy of Glycerol, Two Topical Steroids, and a Topical Immune Modulator Against Experimentally Induced Skin Irritation', 'orgStudyIdInfo': {'id': '2008-001678-34'}}, 'armsInterventionsModule': {'interventions': [{'name': 'clobetasol', 'type': 'DRUG', 'otherNames': ['Dermovate'], 'description': '0.5 mg Clobetasol propionate (0.5 mg/g) ointment applied twice daily for 10 consecutive days'}, {'name': 'triamcinolone acetonide', 'type': 'DRUG', 'otherNames': ['Kenalog'], 'description': '0.5 mg ointment twice daily for 10 consecutive days'}, {'name': 'tacrolimus', 'type': 'DRUG', 'otherNames': ['Protopic'], 'description': '0.5 mg tacrolimus ointment(0.1%) twice daily for 10 consecutive days'}, {'name': 'glycerol', 'type': 'DRUG', 'description': '0.5 mg glycerol ointment (20%) twice daily for 10 consecutive days'}, {'name': 'vehicle ointment (paraffin oil/soft white paraffin)', 'type': 'DRUG', 'description': '0.5 mg vehicle ointment twice daily for 10 consecutive days'}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Department of Dermatology, Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Anders Clemmensen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Dermatology, Odense University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'LEO Pharma', 'class': 'INDUSTRY'}, {'name': 'University of Southern Denmark', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Anders Clemmensen, MD', 'oldOrganization': 'Odense University Hospital'}}}}