Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2025-12-27 @ 9:24 PM
Study NCT ID:
NCT05254561
Status:
COMPLETED
Last Update Posted:
2022-02-24
First Post:
2022-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Triple Antigen vs Monoantigen Immunotherapy for Warts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014860', 'term': 'Warts'}], 'ancestors': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D017193', 'term': 'Skin Diseases, Viral'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014373', 'term': 'Tuberculin'}], 'ancestors': [{'id': 'D000942', 'term': 'Antigens, Bacterial'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000941', 'term': 'Antigens'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double masking'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-14', 'studyFirstSubmitDate': '2022-02-14', 'studyFirstSubmitQcDate': '2022-02-14', 'lastUpdatePostDateStruct': {'date': '2022-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall complete response of both treated and distant warts', 'timeFrame': 'within 12 weeks of starting treatment sessions (up to 1 month after the last session, maximum 5 sessions)'}, {'measure': 'Immediate adverse effects', 'timeFrame': 'during and till 20 minutes after intralesional injection immunotherapy'}], 'secondaryOutcomes': [{'measure': 'Distant wart clearance', 'timeFrame': 'within 12 weeks of starting sessions'}, {'measure': 'Time to complete clearance', 'timeFrame': 'within 12 weeks of starting therapy'}, {'measure': 'late adverse effects', 'timeFrame': 'after each session and till the end of sessions and 6 months-follow-up period'}, {'measure': 'Recurrence', 'timeFrame': 'For 6 months after complete response'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['triple intralesional immunotherapy', 'Warts', 'tuberculin purified protein derivative', 'Candida antigen', 'Measles-Mumps-Rubella vaccine', 'combination immunotherapy'], 'conditions': ['Triple Intralesional Immunotherapy Combination in Multiple Recalcitrant Warts']}, 'descriptionModule': {'briefSummary': 'Warts can be resistant to treatment or return despite the use of many therapeutic modalities. Combining immunotherapy might contribute to better response rates, particularly in recalcitrant warts, which is a real therapeutic challenge. The purpose of this study was to assess the effectiveness and safety of a triple intralesional immunotherapy combination composed of PPD, Candida antigen and MMR versus either agent alone in the management of multiple recalcitrant warts.', 'detailedDescription': 'This study included 160 patients with multiple (\\>3 warts) recalcitrant (at least 6 months duration and who did not respond to at least 2 treatment modalities) warts of different sites, size and duration, with or without distant warts after approval of the Institutional Review Board of Faculty of medicine, Zagazig university. They were randomly assigned to one of four groups (each with 40 patients): PPD, Candida antigen, MMR, or combination of the 3 antigens. Injections into the biggest wart were repeated every two weeks until clearance or for a total of five sessions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Multiple (\\> 3 warts) recalcitrant (at least 6 months duration and who did not respond to at least 2 treatment modalities) warts of different sites, size and duration\n\nExclusion Criteria:\n\n1. Patients with acute febrile illness or past history of asthma.\n2. Allergic skin disorders such as generalized eczema and urticaria.\n3. Past history of meningitis or convulsions.\n4. Pregnancy or lactation.'}, 'identificationModule': {'nctId': 'NCT05254561', 'briefTitle': 'Triple Antigen vs Monoantigen Immunotherapy for Warts', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Triple Intralesional Antigen Immunotherapy Versus Monoantigen in the Treatment of Multiple Recalcitrant Warts', 'orgStudyIdInfo': {'id': 'IRB# 6526/-15-11-2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'purified protein derivative (PPD)', 'description': 'Group A', 'interventionNames': ['Biological: Intralesional antigen immunotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Candida antigen.', 'description': 'Group B', 'interventionNames': ['Biological: Intralesional antigen immunotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Measles, Mumps and Rubella vaccine (MMR).', 'description': 'Group C', 'interventionNames': ['Biological: Intralesional antigen immunotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Triple combination of PPD, Candida antigen and MMR', 'description': 'Group D', 'interventionNames': ['Biological: Intralesional antigen immunotherapy']}], 'interventions': [{'name': 'Intralesional antigen immunotherapy', 'type': 'BIOLOGICAL', 'otherNames': ['PPD, Candida antigen, and MMR'], 'description': 'Randomized double-blinded comparative effectiveness and safety clinical trial', 'armGroupLabels': ['Candida antigen.', 'Measles, Mumps and Rubella vaccine (MMR).', 'Triple combination of PPD, Candida antigen and MMR', 'purified protein derivative (PPD)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44519', 'city': 'Zagazig', 'state': 'Sharqia Province', 'country': 'Egypt', 'facility': 'Zagazig university', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Basma Magdy Elkholy, MD', 'investigatorAffiliation': 'Zagazig University'}}}}