Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2026-02-25 @ 9:39 PM
Study NCT ID:
NCT06718192
Status:
RECRUITING
Last Update Posted:
2025-03-24
First Post:
2024-12-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Controlled Trial to Evaluate the Effectiveness of Bleomycin and Cryotherapy in Treating Plantar Warts.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001761', 'term': 'Bleomycin'}, {'id': 'D017679', 'term': 'Cryotherapy'}], 'ancestors': [{'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-20', 'studyFirstSubmitDate': '2024-12-02', 'studyFirstSubmitQcDate': '2024-12-02', 'lastUpdatePostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the rate of warts complete clearance', 'timeFrame': '2 weeks after treatment endpoint'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['verruca plantaris', 'Bleomycin', 'cryotherapy', 'efficiency', 'security'], 'conditions': ['Verruca Plantaris']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy of bleomycin and cryopreservation in the treatment of plantar verruca by dermoscopy and explore the influencing factors. Compare the safety, economic burden and impact on quality of life of the two treatments', 'detailedDescription': 'Our research aims to evaluate and compare the effectiveness of bleomycin and cryotherapy in treating plantar warts. First, we enrolled patients according to eligibility criteria. Second, the patients were assigned to two groups randomly. One is Bleomycin Group and the other is Cryotherapy Group which means two -group-patients were received different therapies. Thirdly, we compared the efficiency of two groups by using dermoscopy. Finnally, we used statistical analysis to analyze the research data and draw the experimental conclusions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nAge 18-65 years old, gender is not limited; Consistent with the diagnosis of plantar warts; Volunteer for treatment and sign informed consent; Consent to photograph the lesion; The treatment target area can be selected (the target area must meet the following conditions: The distance between adjacent warts in the target area is \\>0.5cm; The diameter of a single wart in the target area is ≤1.5cm, and/or the diameter of a wart mass is ≤1.5cm; The number of total warts/wart masses in the target area is ≤10).\n\nExclusion Criteria:\n\nPatients who can't sign informed consent; Had previously received local treatment for common warts within 1 month; hiv-positive patient; Pregnant and lactating women; Has peripheral vascular disease; Allergic to bleomycin; People who are severely immunocompromised, or who are taking immunosuppressive drugs; Mental illness or cognitive incapacity; Other conditions deemed unsuitable for inclusion, such as inability to cooperate with follow-up, were considered by the researchers."}, 'identificationModule': {'nctId': 'NCT06718192', 'briefTitle': 'A Randomized Controlled Trial to Evaluate the Effectiveness of Bleomycin and Cryotherapy in Treating Plantar Warts.', 'organization': {'class': 'OTHER', 'fullName': 'The Fourth Affiliated Hospital of Zhejiang University School of Medicine'}, 'officialTitle': 'A Randomized Controlled Trial to Evaluate the Effectiveness of Bleomycin and Cryotherapy in Treating Plantar Warts.', 'orgStudyIdInfo': {'id': 'KY-2024-206'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bleomycin Group', 'interventionNames': ['Other: Bleomycin injection']}, {'type': 'OTHER', 'label': 'cryotherapy', 'interventionNames': ['Other: Cryotherapy']}], 'interventions': [{'name': 'Bleomycin injection', 'type': 'OTHER', 'description': 'Wart injection (0.2 mL \\<5 mm; 0.5 mL 5-10 mm; 1ml for \\>10 mm) were injected at a depth of 1.5mm, diluted with normal saline at a concentration of 3u/ml=3mg/ml, and the maximum amount of each wart was 1ml until the wart turned white', 'armGroupLabels': ['Bleomycin Group']}, {'name': 'Cryotherapy', 'type': 'OTHER', 'description': 'The wart was frozen by liquid nitrogen until a circle of frozen tissue appeared around the wart for about 10s, with an interval of 30s, for a total of 2 times', 'armGroupLabels': ['cryotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Yiwu', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lunfei Liu, Master', 'role': 'CONTACT', 'email': 'liulunfei_zeyy@163.com', 'phone': '17816698735'}], 'facility': 'The Fourth Affiliated Hospital Zhejiang University School of Medicine', 'geoPoint': {'lat': 29.31506, 'lon': 120.07676}}], 'centralContacts': [{'name': 'Lunfei Liu, Master', 'role': 'CONTACT', 'email': 'liulunfei_zeyy@163.com', 'phone': '17816698735'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Fourth Affiliated Hospital of Zhejiang University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}