Ignite Creation Date:
2025-12-26 @ 11:47 AM
Ignite Modification Date:
2025-12-26 @ 11:47 AM
Study NCT ID:
NCT05622916
Status:
UNKNOWN
Last Update Posted:
2022-11-21
First Post:
2022-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Topical Ethanol Extract (Piper Crocatum) for Anogenital Warts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003218', 'term': 'Condylomata Acuminata'}], 'ancestors': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014860', 'term': 'Warts'}, {'id': 'D017193', 'term': 'Skin Diseases, Viral'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000431', 'term': 'Ethanol'}, {'id': 'D014238', 'term': 'Trichloroacetic Acid'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D062845', 'term': 'Chloroacetates'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D006843', 'term': 'Hydrocarbons, Chlorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'participants will be blind from the allocation by mimicking the topical solution'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'One group will receive the intervention, whereas the comparison group will receive standard care'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-11-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-14', 'studyFirstSubmitDate': '2022-11-14', 'studyFirstSubmitQcDate': '2022-11-14', 'lastUpdatePostDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse reaction', 'timeFrame': 'any adverse event from baseline to week 12', 'description': 'any records of adverse reaction including inflammation, irritation or other systemic adverse event'}], 'primaryOutcomes': [{'measure': 'Size of wart', 'timeFrame': 'Changes of wart size from baseline to week 12', 'description': 'the size of wart measured from the outermost edge of the warts.'}, {'measure': 'Foxp3+ regulatory T (Treg)', 'timeFrame': 'change of Foxp3+ regulatory T (Treg) expression from baseline to week 8', 'description': 'the expression of Foxp3+ regulatory T (Treg) from the stained T cells in anogenital wart lesion'}, {'measure': 'TGF-β1', 'timeFrame': 'change of TGF-β1 expression from baseline to week 8', 'description': 'the expression of TGF-β1 from the stained cells in anogenital wart lesion'}, {'measure': 'IFN-γ', 'timeFrame': 'change of IFN-γ expression from baseline to week 8', 'description': 'the expression of IFN-γ from the stained cells in anogenital wart lesion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anogenital Wart', 'Trichloroacetic', 'Piper crocatum', 'Clinical Efficacy', 'Inflammatory Marker'], 'conditions': ['Anogenital Wart']}, 'referencesModule': {'references': [{'pmid': '17609022', 'type': 'BACKGROUND', 'citation': 'Sherrard J, Riddell L. Comparison of the effectiveness of commonly used clinic-based treatments for external genital warts. Int J STD AIDS. 2007 Jun;18(6):365-8. doi: 10.1258/095646207781024711.'}, {'pmid': '32735077', 'type': 'BACKGROUND', 'citation': 'Gilson R, Nugent D, Werner RN, Ballesteros J, Ross J. 2019 IUSTI-Europe guideline for the management of anogenital warts. J Eur Acad Dermatol Venereol. 2020 Aug;34(8):1644-1653. doi: 10.1111/jdv.16522.'}, {'pmid': '24330738', 'type': 'BACKGROUND', 'citation': 'Sazwi NN, Nalina T, Abdul Rahim ZH. Antioxidant and cytoprotective activities of Piper betle, Areca catechu, Uncaria gambir and betel quid with and without calcium hydroxide. BMC Complement Altern Med. 2013 Dec 11;13:351. doi: 10.1186/1472-6882-13-351.'}, {'type': 'BACKGROUND', 'citation': 'Pharm T, Hartini YS, Wahyuono S, Widyarini S, Yuswanto A. Hartini et al In vivo Immunomodulatory Effect and Histopathological Features of Mouse Liver and Kidney Treated with Neolignans Isolated from Red Betel (Piper crocatum Ruiz & Pav) Leaf. Tropical Journal of Pharmaceutical Research. 2014;13:1609-1614. doi:10.4314/tjpr.v13i10.6'}, {'pmid': '30192406', 'type': 'BACKGROUND', 'citation': 'Bonin CM, Padovani CTJ, da Costa IP, Avila LS, Ferreira AMT, Fernandes CES, Dos Santos AR, Tozetti IA. Detection of regulatory T cell phenotypic markers and cytokines in patients with human papillomavirus infection. J Med Virol. 2019 Feb;91(2):317-325. doi: 10.1002/jmv.25312. Epub 2018 Sep 24.'}, {'pmid': '19077104', 'type': 'BACKGROUND', 'citation': 'Xu Y, Zhu KJ, Zhu N, Jiang DH, Chen XZ, Cheng H. Expression of Foxp3+CD4+CD25+ regulatory T cells and Th1/Th2, Tc1/Tc2 profiles in the peripheral blood of patients with condyloma acuminatum. Clin Exp Dermatol. 2009 Mar;34(2):229-35. doi: 10.1111/j.1365-2230.2008.03001.x. Epub 2008 Dec 2.'}]}, 'descriptionModule': {'briefSummary': 'This clinical trial aims to assess the efficacy of topical Piper crocatum in treating Anogenital warts. It aims to answer\n\n* the clinical efficacy of treating anogenital warts\n* the expression of Foxp3+ regulatory T (Treg), TGF/Tumor Growth Factor -β1, and IFN/interferon -γ of anogenital wart lesion Participants will be allocated into two topical treatments, intervention and active comparator Trichloroacetic Acid (TCA) 90%. The researchers assume that intervention is superior compared to TCA 90%', 'detailedDescription': 'Study Design :\n\nA randomized controlled trial\n\nPopulation:\n\nDiagnosed with Condyloma Acuminata (International Classification of Disease 10 code A.63.0)\n\nIntervention period :\n\n8 weeks of daily topical intervention with follow-up at week 12\n\nDetailed formulation\n\n1. Extraction of Piper crocatum with ethanol assisted in a microwave-assisted extraction (MAE)\n2. The dissolution and active substances are separated by evaporation using a rotary evaporator to obtain the extract in the form of a thick solution\n3. freeze-drying is performed to obtain a stable thick extract\n4. preparation of ointment by adding formulation of ethanol extract of red betel leaves with 50 mg of white vaseline to achieve 30% concentration\n\nSettings:\n\nOutpatient care at the designated hospital\n\nParticipants:\n\nConsecutive recruitment\n\nSample Size Estimation:\n\nFollowing the formula of two different means, with the indicator, as follows:\n\n1. Type 1 error 5%\n2. Power of Study 80%\n3. Assuming the effect size of cohen d (in reducing the size of warts) is 0.5\n4. equal allocation between two arms total sample: 100 participants\n\nProposed analysis:\n\nIntention to treat (ITT) with sensitivity and subgroup analysis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Men and women diagnosed with external anogenital warts\n2. Clinical lesions of Anogenital Wart at least 3 lesions with a size of 1-5 cm\n3. In patients with HIV, Cluster of Differentiation 4 (CD4)cell count \\>350 cells/mm and have been taking antiretroviral (ARV) drugs regularly for 3 months,\n\nExclusion Criteria:\n\n1. Pregnant or lactating women\n2. Lesions located in the external urethral orifice and vagina\n3. Using systemic immunomodulators/immunosuppressants\n\nThe protocol treatment will be discontinued if patients\n\na. Withdraw their consent based on the patient's demand d. Severe adverse events occurred or allergies to the components of the test product b. After undergoing clinical trials, the patient experienced things that caused him/her to no longer meet the criteria set out in this protocol. c. Subjects do not comply the established study protocol"}, 'identificationModule': {'nctId': 'NCT05622916', 'briefTitle': 'Topical Ethanol Extract (Piper Crocatum) for Anogenital Warts', 'organization': {'class': 'OTHER', 'fullName': 'Hasanuddin University'}, 'officialTitle': 'The Efficacy of Ethanol Extract of Red Betel Leaves (Piper Crocatum) as Topical Patient-Applied Therapy In Anogenital Warts The Study of Foxp3+ Treg, Tumor Growth Factor (TGF)-β1, and Interferon (IFN)-γ Expression', 'orgStudyIdInfo': {'id': '1114222112'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Daily topical application (twice/day, in the morning and 30-60 minutes before bed at night) for 56 days.', 'interventionNames': ['Drug: Topical Ethanol Extract (Piper crocatum)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparison', 'description': 'Weekly application (1x/week) by the physician for 8 weeks', 'interventionNames': ['Drug: Trichloroacetic Acid Topical']}], 'interventions': [{'name': 'Topical Ethanol Extract (Piper crocatum)', 'type': 'DRUG', 'otherNames': ['Red Betel Leaves'], 'description': 'Topical ethanol extract of red betel leaves (Piper crocatum) 30% with the details of formulation on detailed description section', 'armGroupLabels': ['Intervention']}, {'name': 'Trichloroacetic Acid Topical', 'type': 'DRUG', 'otherNames': ['TCA 90'], 'description': 'Trichloroacetic acid topical 90%', 'armGroupLabels': ['Comparison']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76124', 'city': 'Makassar', 'state': 'South Sulawesi', 'country': 'Indonesia', 'contacts': [{'name': 'Agussalim Bukhari, MD, Ph.D.', 'role': 'CONTACT', 'email': 'fkunhas@med.unhas.ac.id', 'phone': '+62 411 583333'}, {'name': 'Idrianti Idrus, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Wresti Indriatmi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Franciscus D Suyatna, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Wahidin Sudirohusodo General Hospital', 'geoPoint': {'lat': -5.14861, 'lon': 119.43194}}], 'centralContacts': [{'name': 'Idrianti Idrus, MD', 'role': 'CONTACT', 'email': 'rasiah.05@gmail.com', 'phone': '+624118910174'}], 'overallOfficials': [{'name': 'Idrianti Idrus, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hasanuddin University'}, {'name': 'Wresti Indriatmi, MD. Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indonesia University'}, {'name': 'Fransiscus Suyatna, MD. Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indonesia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'de-identified data will be shared for specific purpose, including article review'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hasanuddin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer', 'investigatorFullName': 'Bumi Herman', 'investigatorAffiliation': 'Hasanuddin University'}}}}