Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2025-12-24 @ 3:55 PM
Study NCT ID:
NCT01676792
Status:
COMPLETED
Last Update Posted:
2014-04-22
First Post:
2012-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SR-T100 Gel Efficacy & Safety Study for Vulva Pre-cancerous Lesions & Cutaneous Condyloma
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'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-21', 'studyFirstSubmitDate': '2012-08-29', 'studyFirstSubmitQcDate': '2012-08-29', 'lastUpdatePostDateStruct': {'date': '2014-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety', 'timeFrame': '16 weeks', 'description': 'To evaluate safety profile of SR-T100 gel by adverse events, serious adverse events, PEs, vital signs \\& laboratory data changes.'}], 'primaryOutcomes': [{'measure': 'Patients achieve greater than or equal to 75% lesion size reduction', 'timeFrame': '20 weeks (16 weeks treatment period + 4 weeks follow-up period)', 'description': 'Proportion of patients achieving greater than or equivalent to 75% lesion size reduction from baseline on the 20th week after 16 weeks of SR-T100 gel treatment'}], 'secondaryOutcomes': [{'measure': 'Total clearance rate', 'timeFrame': '20 weeks (16 weeks treatment period + 4 weeks follow-up period)', 'description': 'Proportions of patient with treated VIN(s) or EGW(s) completely eradicate.'}, {'measure': 'Partial clearance rate', 'timeFrame': '20 weeks (16weeks treatment period + 4 weeks follow-up period', 'description': 'Proportions of patient with treated VIN(s) or EGW(s) size reduction is greater than 75% in volume from baseline.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['condyloma acuminate', 'ano-genital warts', 'genital warts', 'cutaneous condyloma', 'Vulva pre-cancerous lesions', 'Vulvar Intraepitheral Neoplasia', 'VIN', 'EGW'], 'conditions': ['Vulvar Intraepithelial Neoplasia', 'Genital Warts']}, 'descriptionModule': {'briefSummary': 'This pilot clinical study is to evaluate the efficacy \\& safety of SR-T100 gel (2.3% of SM in Solanum undatum plant extract) in patients with VIN(s) or EGW(s).', 'detailedDescription': 'An open-label, pilot study to evaluate the efficacy \\& safety profiles of SR-T100 gel in treating patients with VINs or EGWs. Male \\& female older than 20 years old have at least one VIN or EGW with lesion size greater than 5 mm in diameter are candidates for this study. The primary endpoint is evaluated based on patients who has received 16-week treatment and presents evaluable measurement datas by the end of 20th week. The secondary endpoints will be evaluated based on all patients with measurable values for VINs or EGWs, recruited patients in this study has never had experiencs associated with prior SR-T100 treatment of any sorts during their life time before becoming a participant in this study. The study plans to recruit 20 patients with VINs or EGWs, the enrollment duration will last two years with total of 40 patients involved.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '(EGW group)Inclusion Criteria:\n\n* Male \\& female patients older than 20 years old presents at least one pathologically confirmed with histopathology EGW with lesion size greater than 5mm in diameter.\n\n(EGW group)Exclusion Criteria:\n\n* Patients with invasive neoplasia, enlarged lymph nodes invasive squamous cell carcinoma, having treated with other investigational drugs within 30 days, pregnancy \\& lactating females, female with pregnancy potential without using effective boundary barrier or patients with immune-deficience.\n\n(VIN group)Inclusion Criteria:\n\n* Female patients older than 20 years old presents at least one histopathologically confirmed VIN with lesion size greater than 5mm in diameter.\n\n(VIN group)Exclusion Criteria:\n\n* Patients with invasive neoplasia, enlarged lymph nodes invasive squamous cell carcinoma, having treated with other investigational drugs within 30 days, pregnancy \\& lactating females, female with pregnancy potential without using effective boundary barrier or patients with immune-deficience.'}, 'identificationModule': {'nctId': 'NCT01676792', 'briefTitle': 'SR-T100 Gel Efficacy & Safety Study for Vulva Pre-cancerous Lesions & Cutaneous Condyloma', 'organization': {'class': 'OTHER', 'fullName': 'National Cheng-Kung University Hospital'}, 'officialTitle': 'A Pilot Study to Assess the Efficacy & Safety of Topical SR-T100 Gel in the Treatment of Human Vulva Pre-cancerous Lesions (Vulvar Intraepithelial Neoplasia; VIN) & Cutaneous Condyloma(External Genital Warts; EGWs)', 'orgStudyIdInfo': {'id': '100CT221'}, 'secondaryIdInfos': [{'id': '100CT221', 'type': 'OTHER', 'domain': 'National Research Program for Biopharmaceuticals, NRPB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lesion reduction', 'interventionNames': ['Drug: SR-T100 gel with 2.3% of SM in Solanum undatum plant extract']}], 'interventions': [{'name': 'SR-T100 gel with 2.3% of SM in Solanum undatum plant extract', 'type': 'DRUG', 'otherNames': ['SR-T100 gel'], 'description': 'Self administered topical SR-T100 gel on lesion(s) including its peripheral normal skin approximately 1cm around the lesion with the amount of 0.02 g/cm squared with occlusive dressing once daily. Patients who is unable to tolerate with occlusive dressing is instructed 3 times daily in the morning, afternoon \\& before bed time. Medication should be reapply after bathing or cleaning.', 'armGroupLabels': ['Lesion reduction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '744', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'National Cheng Kung University Hospital', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}], 'overallOfficials': [{'name': 'Keng-Fu Hsu, MD, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cheng-Kung University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cheng-Kung University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'G&E Herbal Biotechnology Co., LTD', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}