Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2026-01-29 @ 3:38 PM
Study NCT ID:
NCT00646867
Status:
COMPLETED
Last Update Posted:
2008-05-22
First Post:
2008-03-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Tetrix on Alleviation of Burning,Itching Associated With Lesions of Contact Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003877', 'term': 'Dermatitis, Contact'}, {'id': 'D011537', 'term': 'Pruritus'}], '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': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-05-19', 'studyFirstSubmitDate': '2008-03-26', 'studyFirstSubmitQcDate': '2008-03-28', 'lastUpdatePostDateStruct': {'date': '2008-05-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in symptoms of burning and itching.', 'timeFrame': 'after 14 days of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tetrix cream, contact dermatitis, effect on burning and itching'], 'conditions': ['Contact Dermatitis']}, 'descriptionModule': {'briefSummary': 'To determine if Tetrix Cream, when applied to the skin lesions on patients with contact dermatitis, improves the symptoms of burning and itching.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Normal subjects with sensitivity to nickel\n2. Subjects with hand eczema\n\nExclusion Criteria:\n\nunder 18 years of age'}, 'identificationModule': {'nctId': 'NCT00646867', 'briefTitle': 'Effect of Tetrix on Alleviation of Burning,Itching Associated With Lesions of Contact Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Coria Laboratories, Ltd.'}, 'officialTitle': 'An Open Label Study of the Therapeutic Effects of Tetrix Cream in Allergic Contact and Irritant Contact Dermatitis', 'orgStudyIdInfo': {'id': '805 806 09 004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Experimental', 'interventionNames': ['Device: Tetrix']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo', 'interventionNames': ['Device: Placebo']}], 'interventions': [{'name': 'Tetrix', 'type': 'DEVICE', 'description': 'Twice daily topical application', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DEVICE', 'description': 'Twice daily topical application', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Dermatology Specialists, LLC', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}], 'overallOfficials': [{'name': 'Joseph Fowler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dermatology Specialists, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coria Laboratories, Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'D. Innes Cargill, PhD', 'oldOrganization': 'Coria Laboratories, Ltd.'}}}}