Ignite Creation Date:
2025-12-24 @ 1:42 PM
Ignite Modification Date:
2025-12-27 @ 10:33 PM
Study NCT ID:
NCT05146895
Status:
UNKNOWN
Last Update Posted:
2021-12-07
First Post:
2021-08-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Cohort Study of Hyperthermia and Imiquimod for the Treatment of Flat Warts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000084462', 'term': 'Hyperthermia'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D018882', 'term': 'Heat Stress Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-06-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-23', 'studyFirstSubmitDate': '2021-08-17', 'studyFirstSubmitQcDate': '2021-11-23', 'lastUpdatePostDateStruct': {'date': '2021-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clearance rates of HPV', 'timeFrame': '3 months after the last time of treatment', 'description': 'to evaluate the clearance rates of all lesions in different treatment groups 3 month after treatment.'}], 'secondaryOutcomes': [{'measure': 'effective rates of HPV', 'timeFrame': '3 months after the last time of treatment', 'description': 'to evaluate the effective rates of all lesions in different treatment groups 3 month after treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hyperthermia', 'human papillomavirus virus', 'flat warts'], 'conditions': ['Human Papilloma Virus']}, 'descriptionModule': {'briefSummary': "flat warts are a superficial viral skin disease, extremely common in childhood.Treatment of warts is often difficult and involves different destructive procedures.Although several pharmacological and physical topical treatments are available (keratolytic agents, electrosurgery, cryotherapy, carbon dioxide laser), results are often unsatisfactory in terms of efficacy (frequent recurrence) and cosmetic outcome (scars, inflammatory reactions, transient or permanent hyper- or hypopigmentation).\n\nMild local Hyperthermia with a certain temperature range has been successfully used in the treatment of some diseases. It has been utilised in the treatment of some neoplasm, fungal and HPV infections. Investigators' study found that local hyperthermia at 44°C could cleared HPV in more than half of the patients with plantar warts. Investigators also note the fact that in patients with multiple lesions, the clearance of the target lesion is commonly followed by clearance of other distant lesions, a phenomenon suggesting that local hyperthermia could aid in establishing a specific immune response to eliminate HPV.So the purpose of the study is to evaluation local hyperthermia in the treatment of flat warts Appropriate control arms were designed for different conditions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 12-65 years old;\n* diagnosis confirmed;\n* signed informed consent\n\nExclusion Criteria:\n\n* Pregnant woman;\n* Local or systematic treatment within 3 months;\n* Comorbidity of other severe gynecological inflammation,\n* Infection, or tumor;\n* Comorbidity of other serious illnesses;\n* No guarantee of timely treatment and follow-up'}, 'identificationModule': {'nctId': 'NCT05146895', 'briefTitle': 'A Cohort Study of Hyperthermia and Imiquimod for the Treatment of Flat Warts', 'organization': {'class': 'OTHER', 'fullName': 'First Hospital of China Medical University'}, 'officialTitle': 'Evaluation of Local Hyperthermia for the Treatment of Flat Warts After 4 Months: a Single-center, Single-blind, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'HH20190606'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Local Hyperthermia at 44℃ for falt warts', 'description': 'Local hyperthermia at 44℃ for 30 mins on one lesion region, at days of 1,2,3, 15, 16, 21 and 28.', 'interventionNames': ['Device: Local Hyperthermia at 44℃']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Imiquimod for Flat Warts', 'description': 'Miquimod treatment: 3 times a week for 1 month', 'interventionNames': ['Drug: Imiquimod treatment']}], 'interventions': [{'name': 'Imiquimod treatment', 'type': 'DRUG', 'description': 'As an control arm, for patients with flat warts', 'armGroupLabels': ['Imiquimod for Flat Warts']}, {'name': 'Local Hyperthermia at 44℃', 'type': 'DEVICE', 'description': 'As an experimental arm, for patients with flat warts', 'armGroupLabels': ['Local Hyperthermia at 44℃ for falt warts']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110001', 'city': 'Shenyang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'xinghua gao', 'role': 'CONTACT', 'email': 'gaobarry@hotmail.com', 'phone': '13940152467'}], 'facility': 'the First Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'centralContacts': [{'name': 'Xinghua Gao', 'role': 'CONTACT', 'email': 'gaobarry@hotmail.com', 'phone': '+86 139 4015 2467'}, {'name': 'Shengnan Zhao', 'role': 'CONTACT', 'email': 'zsn15104042205@126.com', 'phone': '+15104042205'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Hospital of China Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Gao Xinghua', 'investigatorAffiliation': 'First Hospital of China Medical University'}}}}