Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2025-12-25 @ 7:26 PM
Study NCT ID:
NCT06077032
Status:
UNKNOWN
Last Update Posted:
2023-10-16
First Post:
2023-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chlorhexidine and Garlic Extract as Potential Topical Virucidal Therapeutic Agents of Non-Genital Warts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012996', 'term': 'Solutions'}, {'id': 'D002710', 'term': 'Chlorhexidine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-13', 'studyFirstSubmitDate': '2023-09-09', 'studyFirstSubmitQcDate': '2023-10-04', 'lastUpdatePostDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '●Evaluate the efficacy and safety of topical chlorhexidine (2%) solution vs garlic extract (15%) solution in treating non-genital warts', 'timeFrame': '6weeks up to 3 month', 'description': 'will be evaluated by changing in the size (using ruler) and the number of lesions.'}, {'measure': '●Side effects (systemic of local) as burning, itching, erythema, pigmentary changes, ulceration, and scarring', 'timeFrame': '6weeks up to 3 month', 'description': 'will be evaluated at each visit.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-Genital Warts']}, 'referencesModule': {'references': [{'pmid': '34890486', 'type': 'BACKGROUND', 'citation': 'Garcia-Oreja S, Alvaro-Afonso FJ, Sevillano-Fernandez D, Tardaguila-Garcia A, Lopez-Moral M, Lazaro-Martinez JL. A non-invasive method for diagnosing plantar warts caused by human papillomavirus (HPV). J Med Virol. 2022 Jun;94(6):2897-2901. doi: 10.1002/jmv.27514. Epub 2021 Dec 15.'}, {'pmid': '34637092', 'type': 'BACKGROUND', 'citation': 'Fernandez MDS, Guedes MIF, Langa GPJ, Rosing CK, Cavagni J, Muniz FWMG. Virucidal efficacy of chlorhexidine: a systematic review. Odontology. 2022 Apr;110(2):376-392. doi: 10.1007/s10266-021-00660-x. Epub 2021 Oct 12.'}, {'pmid': '33075450', 'type': 'BACKGROUND', 'citation': 'Brookes ZLS, Bescos R, Belfield LA, Ali K, Roberts A. Current uses of chlorhexidine for management of oral disease: a narrative review. J Dent. 2020 Dec;103:103497. doi: 10.1016/j.jdent.2020.103497. Epub 2020 Oct 17.'}]}, 'descriptionModule': {'briefSummary': 'Aim(s) of the Research:\n\n1. Evaluate the efficacy and safety of topical chlorhexidine (2%) solution vs garlic extract (15%) solution in treating non-genital warts.\n2. Explore possible relation between therapeutic response with demographic/clinical data.\n3. Identify patients satisfaction with each agent.', 'detailedDescription': 'Cutaneous warts or verruca are common, benign skin growths caused by human papilloma virus (HPV).\n\nThere are several therapeutic modalities for warts: include destructive agents (keratolytics, cryotherapy, curettage and cautery, laser, photodynamic therapy), antimitotic agents (podophyllin, bleomycin, retinoids), immune stimulants (topical sensitizers, cimetidine), and topical virucidal agents (formaldehyde, glutaraldehyde) Unfortunately, no single treatment is satisfactory for all patients. Chlorhexidine gluconate(CHX) is a gluconate salt with a broad-spectrum antiseptic action against Gram-Positive, Gram-negative bacteria, aerobes, facultative anaerobes, and fungi such action is mediated through increasing the permeability of the cell walls of microbes, causing their lysis.\n\nAdditionally, evidence indicates an in vitro effect against many viruses such as influenza A, parainfluenza, herpes virus 1, cytomegalovirus, hepatitis B, HIV and SARS-CoV-2.\n\nIt was hypothesized that the biophysiological mechanisms for the virucidal effect of CHX may be exerted through lysis of viral envelope, deterioration of nucleotide carbon chains, and inactivation and/or blocking of viral proteins.\n\nGarlic (Allium sativum) is one of the most widely used medicinal plants with high therapeutic effects.\n\nClinical effectiveness of oral and topical garlic extract may be attributed to its antimicrobial, antioxidant, anti-inflammatory, anticancer and aging prevention effects.\n\nHowever, the mechanisms of these actions are not clearly known. In vitro studies on garlic showed that garlic may enhance natural killer (NK) cells, which are an important part of the immune system in fighting cancers, viruses and certain bacteria.\n\nPrevious studies showed garlic extract was effective on complete resolution of cutaneous wart.\n\nChlorhexidine has not been used for treatment of warts in previous studies so we decided to explore its efficacy in treatment of warts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with the clinical diagnosis of common or plantar warts.\n\nExclusion Criteria:\n\n* Pregnancy and lactation.\n* Chronic systemic diseases such as chronic renal failure, hepatic insufficiency, and cardiovascular disorders.\n* Patients with inflamed lesions\n* Use of systemic or topical treatments during the last month before enrollment.\n* Individuals with history of allergic reactions to garlic or chlorhexidine\n* Patient with generalized dermatitis or allergic skin disorders'}, 'identificationModule': {'nctId': 'NCT06077032', 'briefTitle': 'Chlorhexidine and Garlic Extract as Potential Topical Virucidal Therapeutic Agents of Non-Genital Warts', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Chlorhexidine and Garlic Extract as Potential Topical Virucidal Therapeutic Agents of Non-Genital Warts: A Prospective, Randomized, Controlled, Blinded Clinical Trial', 'orgStudyIdInfo': {'id': 'treatment of non genital warts'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'garlic extract', 'description': 'Garlic will be collected from Medicinal Plant station, Pharmacognosy Department, Faculty of Pharmacy, Assiut University.\n\nThe fresh garlic bulbs will be crushed. Extraction will be done using maceration method with Ethanol for 24 h at room temperature.\n\nFreeze-drying method will be used to remove solvent and give dry powder. Dry powder will be mixed with isopropyl alcohol in a ultrasonic bath to solve thoroughly.\n\nThe soluble garlic extract will be added to a mixture of Polyethylene Glycol. The topical garlic formulation will be prepared for each time for two weeks-use and will be kept in dark glass containers in refrigerator till prescription.\n\n•Group 1: will apply Vaseline over the normal skin surrounding the lesion(s) then a cotton soaked with garlic extract (15%) solution will be applied under occlusion with a plastic tape for one hour and then washed by tap water daily for 6 weeks.', 'interventionNames': ['Drug: garlic extract (15%) solution']}, {'type': 'EXPERIMENTAL', 'label': 'chlorhexidine', 'description': 'Chlorhexidine 4% (Laries, manufactured by: Smartec Egypt) will be diluted with equal amount of distilled water to obtain a concentration of 2%.\n\n•Group 2: will apply Vaseline over the normal skin surrounding the lesion(s) then a cotton soaked with topical chlorhexidine (2%) solution will be applied under occlusion with a plastic tape for one hour and then washed by tap water daily for 6 weeks.', 'interventionNames': ['Drug: topical chlorhexidine (2%) solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'group3', 'description': '•Group 3: (control) will use normal saline 0.9% as a placebo (they will be treated later on after completion of the study using any of the standard therapies for non-genital warts).', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'garlic extract (15%) solution', 'type': 'DRUG', 'description': '•Group 1: will apply Vaseline over the normal skin surrounding the lesion(s) then a cotton soaked with garlic extract (15%) solution will be applied under occlusion with a plastic tape for one hour and then washed by tap water daily for 6 weeks.', 'armGroupLabels': ['garlic extract']}, {'name': 'topical chlorhexidine (2%) solution', 'type': 'DRUG', 'description': '•Group 2: will apply Vaseline over the normal skin surrounding the lesion(s) then a cotton soaked with topical chlorhexidine (2%) solution will be applied under occlusion with a plastic tape for one hour and then washed by tap water daily for 6 weeks.', 'armGroupLabels': ['chlorhexidine']}, {'name': 'Saline', 'type': 'DRUG', 'otherNames': ['saline 0.9%'], 'description': '•Group 3: (control) will use normal saline 0.9% as a placebo (they will be treated later on after completion of the study using any of the standard therapies for non-genital warts).', 'armGroupLabels': ['group3']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Shaimaa N Ali, studient', 'role': 'CONTACT', 'email': 'shoo_shoo22@yahoo.com', 'phone': '00201060984990'}, {'name': 'Eman R Mohamed, Prof', 'role': 'CONTACT', 'email': 'e_riad@yahoo.com', 'phone': '01005298992'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assuit seed street', 'investigatorFullName': 'Shaimaa Nassar Abd El Hameed Ali', 'investigatorAffiliation': 'Assiut University'}}}}