Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-29 @ 9:26 PM
Study NCT ID:
NCT02941432
Status:
COMPLETED
Last Update Posted:
2017-11-06
First Post:
2016-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Black Tea Compresses for Facial Eczema and Perioral Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004485', 'term': 'Eczema'}, {'id': 'D003872', 'term': 'Dermatitis'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-03', 'studyFirstSubmitDate': '2016-10-16', 'studyFirstSubmitQcDate': '2016-10-20', 'lastUpdatePostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Facial Eczema Activity and Severity Index (patients with facial eczema)', 'timeFrame': 'days 0, 3 and 6'}, {'measure': 'Change in Perioral Dermatitis Severity Score (patients with perioral dermatitis)', 'timeFrame': 'days 0, 3 and 6'}, {'measure': 'Change in Investigator´s Global Assessment Score (all patients)', 'timeFrame': 'days 0, 3 and 6'}, {'measure': 'Change in Patient´s Self-Assessment Score (all patients)', 'timeFrame': 'days 0, 3 and 6'}, {'measure': 'Change in Visual Analog Scale for pruritus in the face (patients with facial eczema)', 'timeFrame': 'days 0, 3 and 6'}, {'measure': 'Change in Visual Analog Scale for tension feeling in the face (patients with perioral dermatitis)', 'timeFrame': 'days 0, 3 and 6'}], 'secondaryOutcomes': [{'measure': 'Side-effects', 'timeFrame': 'days 3 and 6'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Eczema, Dermatitis']}, 'referencesModule': {'references': [{'pmid': '30668184', 'type': 'DERIVED', 'citation': 'Witte M, Krause L, Zillikens D, Shimanovich I. Black tea dressings - a rapidly effective treatment for facial dermatitis. J Dermatolog Treat. 2019 Dec;30(8):785-789. doi: 10.1080/09546634.2019.1573306. Epub 2019 Feb 3.'}]}, 'descriptionModule': {'briefSummary': 'Facial eczema and perioral dermatitis are clinical entities that develop exclusively in the face and present a special therapeutic challenge. Topical corticosteroids that are commonly applied to treat eczema/dermatitis at other body sites are best avoided in the face, as they may result in rapid atrophy of facial skin and in the long term rather aggravate facial dermatoses. Black tea compresses have been successfully used by German-speaking dermatologists to treat facial eczema/dermatitis for decades. The precise mechanism of action is unknown but is presumably based on astringent properties of tannins in the black tea and on the antiinflammatory action of a wet compress as such. This therapy is cheap, universally available and practically free of side-effects. Despite these perceived advantages the effects and tolerance of black tea compresses have not been formally studied to date. Therefore, the investigators plan to treat 25 patients with facial eczema/perioral dermatitis over a period of 6 days each within the current trial. The disease activity will be assessed before, during and after completion of treatment using several clinical scores. In addition, side-effects, if any, will be documented.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of facial eczema or perioral dermatitis\n* minimum age of 18 years\n* patient is capable of granting informed consent\n* patient is expected to comply with the trial treatment protocol\n* for outpatients: close place of residence\n\nExclusion Criteria:\n\n* initiation or increase of systemic immunosuppressive or antibiotic treatment necessary\n* psychiatric disease or other factors making poor patient compliance probable\n* participation in another clinical trial within the past 6 months'}, 'identificationModule': {'nctId': 'NCT02941432', 'briefTitle': 'Black Tea Compresses for Facial Eczema and Perioral Dermatitis', 'organization': {'class': 'OTHER', 'fullName': 'University of Luebeck'}, 'officialTitle': 'Pilot Study of Effects and Tolerance of Black Tea Compress Treatment in Facial Eczema and Perioral Dermatitis', 'orgStudyIdInfo': {'id': 'Black Tea Trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Black tea', 'description': 'Black tea compress treatment', 'interventionNames': ['Other: Black tea compress treatment']}], 'interventions': [{'name': 'Black tea compress treatment', 'type': 'OTHER', 'description': 'Wet compresses with black tea applied 4-5 times daily to the face for 6 days', 'armGroupLabels': ['Black tea']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23538', 'city': 'Lübeck', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'Department of Dermatology, University of Lübeck', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}], 'overallOfficials': [{'name': 'Iakov Shimanovich, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Lübeck'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'It is planned to publish the study results, including anonymized clinical patient data and photographs in a scientific journal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Luebeck', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Dermatologist', 'investigatorFullName': 'Iakov Shimanovich, MD', 'investigatorAffiliation': 'University of Luebeck'}}}}