Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-30 @ 11:28 AM
Study NCT ID:
NCT01176994
Status:
UNKNOWN
Last Update Posted:
2010-08-06
First Post:
2010-08-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of Formalin-free Fixatives for In-Vivo Fixation of Skin Lesions.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012868', 'term': 'Skin Abnormalities'}], 'ancestors': [{'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2012-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-08-05', 'studyFirstSubmitDate': '2010-08-05', 'studyFirstSubmitQcDate': '2010-08-05', 'lastUpdatePostDateStruct': {'date': '2010-08-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety', 'timeFrame': 'One year', 'description': 'Infiltration of formulations into skin lesions.'}, {'measure': 'Safety of formulations', 'timeFrame': 'One year', 'description': 'Infiltration of the formulations into skin lesions with resultant in-vivo fixation and the achievement of histological result. Possible local pain, infection and scarring will be evaluated.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Patients with skin lesions that are treated by dermatologists with destructive modalities without histological evaluation.'], 'conditions': ['Skin Abnormality']}, 'descriptionModule': {'briefSummary': 'Existing methods of diagnosing and treating skin lesions are either surgical, which enables an histological diagnosis or destructive (electrodesiccation, liquid nitrogen, laser, caustics) with no possibility of obtaining histology. The ingredients of current formulations for in-vivo skin fixation (Mohs, Solcoderm) are unstable, inconvenient for application and painful - therefore their use was abandoned. The investigators will examine the safety of stable formalin-free formulations for in-vivo fixation of human skin lesions .These formulations were safe and had a rapid onset of fixation effect in in-vivo animal studies.', 'detailedDescription': 'The formulations are comprised of standard non-toxic laboratory chemicals that are used in various dermatological preparations.\n\nTransition metal salts - Zinc chloride, zinc bromide, zinc iodide,zinc nitrate, zinc sulphate. copper chloride ,copper bromide, copper iodide, copper nitrate, copper sulphate.\n\nKeratolytics - salicylic acid , lactic acid, nitric acid, pyruvic acid,oxalic acid, trichloro acetic acid, phenol, resorcinol,urea .\n\nThe solvents and penetration enhancers of the ingredients - Water, ethanol, dimethyl sulfoxide, propylene glycol, glycerol.\n\nPatients with skin lesions that after clinical diagnosis are usually treated by dermatologists with destructive modalities without an histological evaluation will be included in the study. The clinical diagnoses include viral warts, seborrheic warts, skin tags, solar keratoses, fibromata and hemangiomata.\n\nThe treated lesions will be located on the trunk and limbs. Lesions on the face will not be included in the study.\n\nThe formulations will be infiltrated intra-dermally into the lesions in a maximal volume not exceeding 0.05 ml.\n\nAfter the achievement of the desired local fixation effect, the lesions will be examined by a pathologist.\n\nThe patients will be closely followed-up during the procedure and the degree of possible associated pain will be evaluated. Possible local infection and the degree of scarring will be evaluated until complete healing of the treated area will occur.\n\nThe histological result will be informed to the patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with skin lesions that are not treated with histology\n\nExclusion Criteria:\n\n* Seriously ill patients'}, 'identificationModule': {'nctId': 'NCT01176994', 'briefTitle': 'Safety of Formalin-free Fixatives for In-Vivo Fixation of Skin Lesions.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'officialTitle': 'Safety of Formalin-free Fixatives for In-Vivo Fixation of Skin Lesions.', 'orgStudyIdInfo': {'id': 'HYMC-0016-09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Skin lesions', 'description': 'Individuals with skin lesions whose lesions are not sent for histology by dermatologists', 'interventionNames': ['Device: Formulations for in-vivo fixation']}], 'interventions': [{'name': 'Formulations for in-vivo fixation', 'type': 'DEVICE', 'otherNames': ['Formulation ingredients:'], 'description': 'Formulations are comprised of non-toxic ingredients used in dermatology.', 'armGroupLabels': ['Skin lesions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38100', 'city': 'Hadera', 'country': 'Israel', 'contacts': [{'name': 'Michael Kahana, MD', 'role': 'CONTACT', 'email': 'kahanam@hy.health.gov.il', 'phone': '972-4-630-4667'}, {'role': 'CONTACT', 'email': 'ezrar@bezeqint.net'}, {'name': 'Michael Kahana, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Rafael Ezra, MSc Pharm', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hillel Yaffe Medical Center', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Michael Kahana, MD', 'oldOrganization': 'Hillel Yaffe Medical Center'}}}}