Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2026-02-26 @ 6:53 AM
Study NCT ID:
NCT00568204
Status:
COMPLETED
Last Update Posted:
2013-10-17
First Post:
2007-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Effectiveness of Mexyn-A
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011537', 'term': 'Pruritus'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 279}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2005-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-16', 'studyFirstSubmitDate': '2007-11-30', 'studyFirstSubmitQcDate': '2007-11-30', 'lastUpdatePostDateStruct': {'date': '2013-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treating Pruritus', 'timeFrame': 'three days'}], 'secondaryOutcomes': [{'measure': 'measuring itch-free period after applying the new treatment, effect on sleep disturbance', 'timeFrame': 'three days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pruritus, itching, mexyn-a, clearitch, magicool-plus'], 'conditions': ['Pruritus']}, 'descriptionModule': {'briefSummary': 'Atomised Methoxymethane-in-Aqua (MEXYN-A) a new topical self-chilled, non-steroidal, non-flammable, pressurised spray which embodies in one simultaneous application, most of the currently recognised and effective chemical, mechanical and thermal anti-pruritic therapies and hydrotherapy.', 'detailedDescription': 'The primary clinical endpoint was to establish MEXYN-A efficacy and safety in abolishing or reducing pruritus related to cutaneous diseases, insect bites and poison ivy, within few seconds of the application. The secondary endpoint was to measure the itch free period as a result of the new intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients suffering from severe itching due to : Atopic Dermatitis, contact dermatitis, psoriasis, urticaria, xerosis, prickly heat, genital pruritus, chicken pox, aquagenic pruritus, lichen planus, poison ivey, insect bites.\n* Past experience with the use of at least one conventional medication for pruritus or conventional medication for the same disorder patients suffered.\n\nExclusion Criteria:\n\n* Patients who have taken any anti-pruritic drug during the month prior to participation.\n* Patients who have taken drugs for any reason for 2 days prior to participating in the study.'}, 'identificationModule': {'nctId': 'NCT00568204', 'acronym': 'Mexyn-A', 'briefTitle': 'Study of Effectiveness of Mexyn-A', 'organization': {'class': 'OTHER', 'fullName': 'Evangelical Synod Medical Centre'}, 'officialTitle': 'Proof of Concept of MEXYN-A', 'orgStudyIdInfo': {'id': 'EvangelicalSynodMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Mexyn-A', 'interventionNames': ['Device: Mexyn-A']}], 'interventions': [{'name': 'Mexyn-A', 'type': 'DEVICE', 'otherNames': ['Clearitch, Itcharret, itchclear, Magicool-Plus'], 'description': 'Atomised topical self-chilled pressurised spray', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11111', 'city': 'Cairo', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Evangelical Synod Medical Centre', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Ihab Akhnoukh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Evangelical Synod Medical Centre'}, {'name': 'Ashraf Khella', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Harpur Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Evangelical Synod Medical Centre', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr Ihab Akhnoukh M.D.', 'oldOrganization': 'Evangelical Synod Medical Centre'}}}}