Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT06720467
Status:
COMPLETED
Last Update Posted:
2025-08-17
First Post:
2024-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immunotherapy in Eyelid Viral Papilloma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015817', 'term': 'Eye Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-14', 'studyFirstSubmitDate': '2024-12-01', 'studyFirstSubmitQcDate': '2024-12-05', 'lastUpdatePostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'complete response', 'timeFrame': 'after maximum 6 treatment sessions of intralesional injection with 2 weeks between the successive sessions', 'description': 'to report the complete response defined by the efficacy of intralesional injection of Candida antigen in achieving complete disappearance of eyelid warts and return to normal skin'}], 'secondaryOutcomes': [{'measure': 'partial response', 'timeFrame': 'after maximum 6 treatment sessions of intralesional injection with 2 weeks between the successive sessions', 'description': 'to report Partial response which will be considered when wart regress in size by 50%-99%.'}, {'measure': 'Failure', 'timeFrame': 'after maximum 6 treatment sessions of intralesional injection with 2 weeks between the successive sessions', 'description': 'to report failure which will be considered if less than 50% decrease in wart size.'}, {'measure': 'complications', 'timeFrame': 'after maximum 6 treatment sessions of intralesional injection with 2 weeks between the successive sessions', 'description': 'to report any complications in the form of hypersensitivity reaction, erythema, or induration'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['eyelid warts, candida antigen, eyelid papilloma'], 'conditions': ['Eye Infections']}, 'referencesModule': {'references': [{'pmid': '31328869', 'type': 'BACKGROUND', 'citation': 'Marei A, Nofal A, Alakad R, Abdel-Hady A. Combined bivalent human papillomavirus vaccine and Candida antigen versus Candida antigen alone in the treatment of recalcitrant warts. J Cosmet Dermatol. 2020 Mar;19(3):758-762. doi: 10.1111/jocd.13077. Epub 2019 Jul 22.'}, {'pmid': '26991521', 'type': 'BACKGROUND', 'citation': 'Aldahan AS, Mlacker S, Shah VV, Kamath P, Alsaidan M, Samarkandy S, Nouri K. Efficacy of intralesional immunotherapy for the treatment of warts: A review of the literature. Dermatol Ther. 2016 May;29(3):197-207. doi: 10.1111/dth.12352. Epub 2016 Mar 15.'}, {'pmid': '33410249', 'type': 'BACKGROUND', 'citation': 'Shaker ESE, Doghim NN, Hassan AM, Musafa SS, Fawzy MM. Immunotherapy in cutaneous warts: comparative clinical Study between MMR vaccine, tuberculin, and BCG Vaccine. J Cosmet Dermatol. 2021 Aug;20(8):2657-2666. doi: 10.1111/jocd.13921. Epub 2021 Jan 6.'}]}, 'descriptionModule': {'briefSummary': 'intralesional injection of Candida antigens for treating eyelid warts is supposed to have less destructive effect than other surgical interventions', 'detailedDescription': 'Despite many surgical and interventional modalities of treating ocular warts, all have a destructive nature for this delicate tissue with a high recurrence rate. intralesional injection of Candida antigens was suggested to be an effective and safe treatment for such a condition aim: Providing safe and effective treatment of ocular wart. objective:\n\n1. To determine the efficacy of intralesional injection of Candida antigens in the treatment of eyelids wart\n2. To determine the safety of intralesional injection of Candida antigens in the treatment of eyelids wart\n3. To report complications of intralesional injection of Candida antigens in the treatment of eyelids wart'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with cutaneous eyelid viral warts whether single or multiple, with no concurrent systemic or topical treatment for warts. Patients aged more than 12 years, with sensitivity test, showed induration less than or equal to five mm. and patients can understand and comply with the requirements of the trials.\n\nExclusion Criteria:\n\n* pregnancy, breastfeeding, patients with immunodeficiency; like diabetics. In addition, patients with a history of hypersensitivity to any used component in this trial, asthma, or allergic skin diseases. Moreover, patients on any treatment modality for warts at least 1 month before the start of the study.'}, 'identificationModule': {'nctId': 'NCT06720467', 'briefTitle': 'Immunotherapy in Eyelid Viral Papilloma', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Role of Immunotherapy in the Treatment of Eyelid Viral Papilloma', 'orgStudyIdInfo': {'id': 'immunotherapy in eyelid warts'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patients with eyelid warts will receive treatment in the form of intralesional injection of Candida', 'description': 'Intralesional injection of 0.2 ml of 1/1000 solution of Candida albicans antigen using an insulin syringe directly into the warts; Candida albicans 1:20 w/v 10 ml vial (Allergy Laboratories, INC. Oklahoma City, USA.). The same injection was repeated every 2 weeks until complete clearance for a maximum of six treatment sessions.', 'interventionNames': ['Biological: Intralesional injection of Candida albicans 1:20 w/v 10 ml vial (Allergy Laboratories, INC. Oklahoma City, USA.)']}], 'interventions': [{'name': 'Intralesional injection of Candida albicans 1:20 w/v 10 ml vial (Allergy Laboratories, INC. Oklahoma City, USA.)', 'type': 'BIOLOGICAL', 'description': 'Intralesional injection of 0.2 ml of 1/1000 solution of Candida albicans antigen using an insulin syringe directly into the warts; Candida albicans 1:20 w/v 10 ml vial (Allergy Laboratories, INC. Oklahoma City, USA.). The same injection was repeated every 2 weeks until complete clearance for a maximum of six treatment sessions.', 'armGroupLabels': ['patients with eyelid warts will receive treatment in the form of intralesional injection of Candida']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44519', 'city': 'Zagazig', 'state': 'Zagazig', 'country': 'Egypt', 'facility': 'Zagazig University', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}], 'overallOfficials': [{'name': 'Ayman Marie, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Medical Microbiology and Immunology, Faculty of Medicine, Zagazig University, Egypt'}, {'name': 'Ghada Boghdadi, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Professor of Medical Microbiology and Immunology, Faculty of Medicine, Zagazig University, Egypt'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator, lecturer of ophthalmology, Faculty of Medicine, Zagazig University, Zagazig, Egypt', 'investigatorFullName': 'Marwa Ahmed Khairy Elsayed Essa', 'investigatorAffiliation': 'Zagazig University'}}}}