Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2026-02-22 @ 4:53 PM
Study NCT ID:
NCT05324904
Status:
UNKNOWN
Last Update Posted:
2022-04-13
First Post:
2022-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intralesional Vitamin D3 Versus Intralesional Acyclovir in Treatment of Plantar Warts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D000212', 'term': 'Acyclovir'}], 'ancestors': [{'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-08', 'studyFirstSubmitDate': '2022-03-18', 'studyFirstSubmitQcDate': '2022-04-08', 'lastUpdatePostDateStruct': {'date': '2022-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'complete healing rate', 'timeFrame': '12 weeks', 'description': 'Main outcome variable is the complete healing rate among planter warts patients treated with intralesional vitamin D3 compared to those by Intralesional acyclovir'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Plantar Wart']}, 'descriptionModule': {'briefSummary': 'To evaluate and compare the efficacy and safety of intralesional acyclovir versus intralesional vitamin D3 in the treatment of plantar warts', 'detailedDescription': 'Introduction Warts are common epidermal growths caused by various strains of human papillomavirus (HPV) affecting all age groups. They have an unsightly appearance and are mostly asymptomatic but sometimes may be painful as in the case of palmoplantar warts . Plantar warts is a clinical variant that occur on sole of the foot, most frequently over pressure points .\n\nIt is estimated that 40% of population is infected with HPV, and in 7% to 12%, a wart develops . Plantar warts exhibit an annual incidence of 14% in the general population . Sixty-five percent to 78% of cutaneous warts have been shown to regress within 2 years . In persons older than 12 years, the rate of spontaneous regression significantly decreases .\n\nVariable therapeutic options are available for treating warts, with none considered a gold standard. Primary treatments include topical salicylic acid, topical imiquimod, topical 5-fluorouracil, cryotherapy, excision, electrocautry and laser vaporization .\n\nVitamin D is a fat-soluble steroid prohormone that has wide range of biological actions e.g. inhibition of cellular proliferation, induction of terminal differentiation, and inhibition of angiogenesis. It also stimulates macrophages and cathelicidin production . Recently, several studies have demonstrated the efficacy of intralesional vitamin D in treatment of warts, as well as recalcitrant lesions, with clearance rates of 72.5%-90% .\n\nAcyclovir is a synthetic purine nucleoside analogue with activity against some viruses as herpes simplex and varicella-zoster virus. Acyclovir uses viral thymidine kinase to convert to its active form, acyclovir triphosphate. Through this mechanism of utilizing viral thymidine kinase, acyclovir specifically targets viral DNA preventing its replication in the host.\n\nPreviously, few studies and case reports documented the clearance of warts, some were unresponsive to prior treatment, with both topical and oral use of acyclovir .\n\nA recent study has evaluated the efficacy of intralesional acyclovir versus intralesional saline in treatment of warts and reported complete clearance rate of 52.6% and a partial response of 16.7% for acyclovir with a statistically significant difference from saline (0% complete clearance) .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult participants of both sex with plantar warts will be included in the study\n\nExclusion Criteria:\n\n* \\- Children \\< 12 years.\n* Pregnant and lactating women.\n* Receiving any treatment for warts within 1 month before the study.\n* Systemic antiviral medication.\n* Previous history of vitamin D or acyclovir hypersensitivity.\n* Vitamin D supplementation.\n* Concurrent other skin disorders.\n* Immunosuppressive disorders or receiving immunosuppressive drugs.\n* Receiving drugs that may alter vitamin D level including prednisone, orlistat, phenytoin and thiazide diuretics.'}, 'identificationModule': {'nctId': 'NCT05324904', 'briefTitle': 'Intralesional Vitamin D3 Versus Intralesional Acyclovir in Treatment of Plantar Warts', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Intralesional Vitamin D3 Versus Intralesional Acyclovir in Treatment of Plantar Warts', 'orgStudyIdInfo': {'id': 'vitamin D3, acyclovir in warts'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group 1', 'description': 'this group will be intralesionaly injected with vitamin D3', 'interventionNames': ['Drug: Vitamin D']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group 2', 'description': 'this group will be intralesionally injected with acyclovir', 'interventionNames': ['Drug: acyclovir']}], 'interventions': [{'name': 'Vitamin D', 'type': 'DRUG', 'description': '\\- Vitamin D\n\n* The aqueous solution of vitamin D3 (cholecalciferol) will be used ampoule 200,000 IU/2 ML,\n* Using a 27-gauge syringe with the bevel facing upward, a maximum of 0.6 ml (60,000 IU) of vitamin D3 solution will be slowly injected into the base of the largest plantar wart (large warts \\> 10 mm need multiple injections at different sites)\n* Treatment sessions will be performed at 3-week intervals for a maximum of 4 sessions', 'armGroupLabels': ['group 1']}, {'name': 'acyclovir', 'type': 'DRUG', 'description': '-Acyclovir\n\n* Acyclovir vial (Zovirax® vial, 250mg, ) will be diluted with 3.5 ml saline to get approximately 70 mg /ml solution.\n* After sterilization of the skin, a 27-gauge syringe with the bevel facing upward will be inserted into the base of the largest plantar wart to slowly inject the solution\n* Treatment sessions will be performed at 2-week intervals for maximum of 5 sessions', 'armGroupLabels': ['group 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assuit University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'maha m mostafa, MD', 'role': 'CONTACT', 'email': 'mahamostafaali@yahoo.com', 'phone': '+201158597040', 'phoneExt': 'a'}, {'name': 'maha m mostafa, MD', 'role': 'CONTACT', 'email': 'mahamostafaali@yahoo.com', 'phone': '01158597040', 'phoneExt': 'a'}], 'overallOfficials': [{'name': 'maha m mostafa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assuit University faculty of medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident physician of Dermatology, Venereology and Andrology, kom Ombo central hospital', 'investigatorFullName': 'maha mostafa ali mostafa', 'investigatorAffiliation': 'Assiut University'}}}}