Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-01 @ 6:01 PM
Study NCT ID:
NCT05429151
Status:
UNKNOWN
Last Update Posted:
2022-06-23
First Post:
2022-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intralesional Injection of Acyclovir Versus Candida Antigen in Treatment of Plantar Warts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-02-08', 'releaseDate': '2023-06-05'}], 'estimatedResultsFirstSubmitDate': '2023-06-05'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D000212', 'term': 'Acyclovir'}, {'id': 'D011208', 'term': 'Powders'}, {'id': 'D012996', 'term': 'Solutions'}], 'ancestors': [{'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-17', 'studyFirstSubmitDate': '2022-06-13', 'studyFirstSubmitQcDate': '2022-06-17', 'lastUpdatePostDateStruct': {'date': '2022-06-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'degree of improvment of wart after intralesional injection of acyclovir and candida antigen', 'timeFrame': '3months after treatment.', 'description': '1. complete response: when 100% complete disappearance of the wart.\n2. partial response: if there is 50% to 99% reduction in its original diameter.\n3. no response: if there reduction in its size \\<50% .'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acyclovir ,candida antigen ,plantar wart'], 'conditions': ['Acyclovir and Candida Antigen in Treatment of Plantar Wart']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the efficacy of intralesional injection of acyclovir versus candida antigen in plantar wart patients will be randomly divided into 2 groups,At least 20 patients will be enrolled in each group.\n\nGroup 1: will be treated with intralesional injection of acyclovir 250 mg acyclovir vial diluted with 3.5 ml saline to get approximately 70 mg/ml solution. The base of each wart was injected with 0.1 ml of intralesional acyclovir (70 mg/ml) every 2 weeks until the resolution of warts or for a maximum of 5 sessions Group 2: will be treated by intralesional Candida antigen injection (candida antigen ) at a dose of 0.2 mL. injected into the largest wart every 2 weeks until complete clearance of warts or for a maximum of 5 treatment sessions.\n\n3.Patient evaluation: Assessment of treatment efficacy and side effects will be carried out by clinical examination and comparative photographic evaluation and dermoscopy', 'detailedDescription': 'patients will be randomly divided into 2 groups, group (1) and group (2). At least 20 patients will be enrolled in each group.\n\nGroup 1: will be treated with intralesional injection of acyclovir (Acyclovir 250mg Powder for Solution for Infusion, each vial contains 250mg of acyclovir as the sodium salt, Chandra Bhagat Pharma Pvt. Ltd) 250 mg acyclovir vial diluted with 3.5 ml saline to get approximately 70 mg/ml solution. During the study, the dosage of the drug and frequency of treatment were uniform in all patients. The base of each wart was injected with 0.1 ml of intralesional acyclovir (70 mg/ml) using an insulin syringe (29 Gage × 0.5-in) every 2 weeks until the resolution of warts or for a maximum of 5 sessions\n\nGroup 2: will be treated by intralesional Candida antigen injection (candida antigen ) at a dose of 0.2 mL. injected into the largest wart using an insulin syringe (29 Gage × 0.5-in) every 2 weeks until complete clearance of warts or for a maximum of 5 treatment sessions.\n\npatients will be followed up for 3months after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The study will include patients with single or multiple planter wart. Age group 18:50 years old\n\nExclusion Criteria:\n\n* : patients with history of renal or liver disease, pregnant and lactating females, patients taking immunosuppressant drugs, patients who received any treatment for wart in the last month before the study.'}, 'identificationModule': {'nctId': 'NCT05429151', 'briefTitle': 'Intralesional Injection of Acyclovir Versus Candida Antigen in Treatment of Plantar Warts', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Clinical and Dermoscopic Study of Intralesional Injection of Acyclovir Versus Candida Antigen in Treatment of Plantar Warts', 'orgStudyIdInfo': {'id': 'Soh-Med-22-06-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group 1', 'description': 'will be treated with intralesional injection of acyclovir (Acyclovir 250mg Powder for Solution for Infusion, each vial contains 250mg of acyclovir as the sodium salt, Chandra Bhagat Pharma Pvt. Ltd) 250 mg acyclovir vial diluted with 3.5 ml saline to get approximately 70 mg/ml solution. During the study, the dosage of the drug and frequency of treatment were uniform in all patients. The base of each wart was injected with 0.1 ml of intralesional acyclovir (70 mg/ml) using an insulin syringe (29 Gage × 0.5-in) every 2 weeks until the resolution of warts or for a maximum of 5 sessions', 'interventionNames': ['Drug: Acyclovir 250mg Powder for Solution for Infusion, each vial contains 250mg of acyclovir as the sodium salt, Chandra Bhagat Pharma Pvt. Ltd andcandida antigen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group 2', 'description': 'will be treated by intralesional Candida antigen injection (candida antigen ) at a dose of 0.2 mL. injected into the largest wart using an insulin syringe (29 Gage × 0.5-in) every 2 weeks until complete clearance of warts or for a maximum of 5 treatment sessions.', 'interventionNames': ['Drug: Acyclovir 250mg Powder for Solution for Infusion, each vial contains 250mg of acyclovir as the sodium salt, Chandra Bhagat Pharma Pvt. Ltd andcandida antigen']}], 'interventions': [{'name': 'Acyclovir 250mg Powder for Solution for Infusion, each vial contains 250mg of acyclovir as the sodium salt, Chandra Bhagat Pharma Pvt. Ltd andcandida antigen', 'type': 'DRUG', 'description': 'Group 1: will be treated with intralesional injection of acyclovir (Acyclovir 250mg Powder for Solution for Infusion, each vial contains 250mg of acyclovir as the sodium salt, Chandra Bhagat Pharma Pvt. Ltd) 250 mg acyclovir vial diluted with 3.5 ml saline to get approximately 70 mg/ml solution. During the study, the dosage of the drug and frequency of treatment were uniform in all patients. The base of each wart was injected with 0.1 ml of intralesional acyclovir (70 mg/ml) using an insulin syringe (29 Gage × 0.5-in) every 2 weeks until the resolution of warts or for a maximum of 5 sessions\n\nGroup 2: will be treated by intralesional Candida antigen injection (candida antigen ) at a dose of 0.2 mL. injected into the largest wart using an insulin syringe (29 Gage × 0.5-in) every 2 weeks until complete clearance of warts or for a maximum of 5 treatment sessions.', 'armGroupLabels': ['group 1', 'group 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'raghda mohamed, resident', 'role': 'CONTACT', 'email': 'raghdamohammad@med.sohag.ed.eg', 'phone': '01009683988'}], 'facility': 'Sohag', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'raghda mohamd hassan, resident', 'role': 'CONTACT', 'email': 'raghdamohammad@med.sohag.edu.eg', 'phone': '01009683988'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident at dermatology venereology andrology department', 'investigatorFullName': 'Raghda Mohamed Hassan', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-06-05', 'type': 'RELEASE'}, {'date': '2024-02-08', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Raghda Mohamed Hassan, resident at dermatology venereology andrology department, Sohag University'}}}}