Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-06-25 @ 3:14 PM
Study NCT ID:
NCT03625960
Status:
COMPLETED
Last Update Posted:
2018-08-10
First Post:
2018-08-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cantharone for the Treatment of Perenial Warts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003218', 'term': 'Condylomata Acuminata'}, {'id': 'D014860', 'term': 'Warts'}], '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': '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': 'D002193', 'term': 'Cantharidin'}, {'id': 'D014238', 'term': 'Trichloroacetic Acid'}], 'ancestors': [{'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D062845', 'term': 'Chloroacetates'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006843', 'term': 'Hydrocarbons, Chlorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'Patients will be randomized to receive treatment with trichloroacetic acid or cantharidine.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized to receive either trichloroacetic acid or cantharidine treatment.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2007-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-07', 'studyFirstSubmitDate': '2018-08-02', 'studyFirstSubmitQcDate': '2018-08-07', 'lastUpdatePostDateStruct': {'date': '2018-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2007-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain on treatment', 'timeFrame': 'at 30 minutes time point from application of treatment.', 'description': 'Comparison of pain when treatment is applied. The patient is asked on a scale of 0-5 (with 5 being extreme pain, 4 being severe pain, 3 being moderate, 2 being mild, 1 being slight and zero being no pain, how do you rate your pain.'}], 'secondaryOutcomes': [{'measure': "Assessment of a patient's likelihood of using this method again as measured on a survey question", 'timeFrame': '2 weeks from starting therapy', 'description': 'A questionnaire given to the patient at the conclusion of the study and containing the question "on a scale from 1-5 (5 most likely) how likely are you to recommend this method to a friend or using it again yourself".'}, {'measure': 'Presence of scarring or skin discoloration', 'timeFrame': '2 weeks from starting therapy', 'description': 'At the time of wart eradication, the treatment area is examined for healing. The clinician rates cosmesis on a scale from 0-5 with 5-skin grows back perfectly, 4-slight discoloration, 3-thickened skin, 1-slight scarring and 0-scarring.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['warts', 'trichloroacetic acid'], 'conditions': ['Wart, Genital']}, 'referencesModule': {'references': [{'pmid': '22479897', 'type': 'BACKGROUND', 'citation': 'Bakardzhiev I, Kovachev E. [Comparative assessment of the methods of treatment of Condylomata acuminata]. Akush Ginekol (Sofiia). 2011;50(4):45-51. Bulgarian.'}, {'pmid': '26239450', 'type': 'RESULT', 'citation': 'Kollipara R, Ekhlassi E, Downing C, Guidry J, Lee M, Tyring SK. Advancements in Pharmacotherapy for Noncancerous Manifestations of HPV. J Clin Med. 2015 Apr 24;4(5):832-46. doi: 10.3390/jcm4050832.'}, {'pmid': '13519856', 'type': 'RESULT', 'citation': 'EPSTEIN WL, KLIGMAN AM. Treatment of warts with cantharidin. AMA Arch Derm. 1958 May;77(5):508-11. doi: 10.1001/archderm.1958.01560050014003. No abstract available.'}, {'pmid': '24643186', 'type': 'RESULT', 'citation': 'Ramirez-Fort MK, Au SC, Javed SA, Loo DS. Management of cutaneous human papillomavirus infection: pharmacotherapies. Curr Probl Dermatol. 2014;45:175-85. doi: 10.1159/000356069. Epub 2014 Mar 13.'}]}, 'descriptionModule': {'briefSummary': 'Comparison of trichloroacetic acid versus cantharidine for the treatment of perenial warts.', 'detailedDescription': 'Warts are one of the most common sexually transmitted diseases. They are caused by the human papilloma virus (HPV) that causes cervical cancer. Warts can grow, obstruct labor, and spread. Patients presenting to the obgyn clinic with perenial warts were randomized to treatment with trichloroacetic acid (one of the many types of treatments) or to the treatment with cantharidine group. Cantharidine is a vesicant extracted from beetle bugs which painlessly causes a small blister to form and cures the patient from the HPV infection causing the wart . We compared cosmesis, scar formation, pain and number of treatments (visits) as well as effectiveness in both groups.\n\nObjectives\n\n1. Determine if cantharone is more effective than trichloroacetic acid (TCA) for removal of warts\n2. Compare pain levels (pain during application) for each method\n3. Compare patient satisfaction for each method\n4. Compare scar formation and cosmesis for each method'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'This is a study on perenial genital warts, near the vulvovaginal area. Only women have vulvovaginas.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Warts on the perenial area\n* Less than 4mm across.\n\nExclusion Criteria:\n\n* Pregnancy\n* Less than 18 years old\n* Lesions larger than 4 millimeters across\n* Unclear diagnosis\n* Internal warts\n* Diabetes\n* HIV\n* Warts within 2 cm of mucosal areas'}, 'identificationModule': {'nctId': 'NCT03625960', 'briefTitle': 'Cantharone for the Treatment of Perenial Warts', 'organization': {'class': 'OTHER', 'fullName': 'Wayne State University'}, 'officialTitle': 'Trichloroacetic Acid Versus Cantharone for the Treatment of Perenial Warts', 'orgStudyIdInfo': {'id': '01551'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cantharidine group', 'description': 'Application of cantharidine to perenial warts', 'interventionNames': ['Drug: Cantharidin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'trichloroacetic acid group', 'description': 'application of trichloroacetic acid to perenial warts', 'interventionNames': ['Drug: Trichloroacetic Acid']}], 'interventions': [{'name': 'Cantharidin', 'type': 'DRUG', 'description': 'A thin film of cantharidin is applied to the surface of the wart and to 1 millimeter area surrounding the wart. After the film dries, it is covered with an occlusive dressing for 24 hours. The patient removes the area the next day and thoroughly washes the area with soap and water. Patients return to clinic a week later.', 'armGroupLabels': ['Cantharidine group']}, {'name': 'Trichloroacetic Acid', 'type': 'DRUG', 'description': 'Trichloroacetic acid is applied to the surface of the wart with a wooden applicator and after drying the area is washed with soap and water in an hour.', 'armGroupLabels': ['trichloroacetic acid group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wayne State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of California, San Francisco', 'class': 'OTHER'}, {'name': "St Vincent's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Clinical Educator', 'investigatorFullName': 'Maurice-Andre Recanati', 'investigatorAffiliation': 'Wayne State University'}}}}