Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 12:32 AM
Study NCT ID:
NCT01159860
Status:
COMPLETED
Last Update Posted:
2018-05-25
First Post:
2010-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is Cryosurgery or Curettage More Effective at Treating Seborrheic Keratoses?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017492', 'term': 'Keratosis, Seborrheic'}], 'ancestors': [{'id': 'D007642', 'term': 'Keratosis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003452', 'term': 'Cryosurgery'}, {'id': 'D003475', 'term': 'Curettage'}], 'ancestors': [{'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2013-06-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-23', 'studyFirstSubmitDate': '2010-07-09', 'studyFirstSubmitQcDate': '2010-07-09', 'lastUpdatePostDateStruct': {'date': '2018-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Partial or complete resolution of treated lesion.', 'timeFrame': '6 weeks', 'description': 'Follow up evaluation by a blinded physician along with the gathering of patient information via questionnaires will be obtained at the completion of the study.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['seborrheic keratoses', 'cryosurgery', 'curettage'], 'conditions': ['Seborrheic Keratosis']}, 'referencesModule': {'references': [{'pmid': '19465852', 'type': 'BACKGROUND', 'citation': 'Brodsky J. Management of benign skin lesions commonly affecting the face: actinic keratosis, seborrheic keratosis, and rosacea. Curr Opin Otolaryngol Head Neck Surg. 2009 Aug;17(4):315-20. doi: 10.1097/MOO.0b013e32832d75e3.'}, {'pmid': '15090020', 'type': 'BACKGROUND', 'citation': 'Herron MD, Bowen AR, Krueger GG. Seborrheic keratoses: a study comparing the standard cryosurgery with topical calcipotriene, topical tazarotene, and topical imiquimod. Int J Dermatol. 2004 Apr;43(4):300-2. doi: 10.1111/j.1365-4632.2004.02282.x.'}]}, 'descriptionModule': {'briefSummary': "Seborrheic keratoses (SK's) are very common, but harmless skin lesions that commonly appear during adult life. Patients with seborrheic keratoses frequently desire treatment due to symptoms of itching and irritation or for cosmetic purposes. Seborrheic keratoses can be easily removed and have been treated in a number of different ways. Two of the simplest and most successful ways to remove seborrheic keratoses are cryosurgery and curettage.\n\nThe investigators are conducting this study to see which of these two treatments has the best result.\n\nApproximately 24-30 people will take part in this research study at the Hershey Medical Center."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* have at least 1 seborrheic keratosis on each side of his/her trunk or proximal extremities.\n* be able to understand the consent form and evaluation of treatment questionnaire.\n\nExclusion Criteria:\n\n* Children \\<18 are excluded from this study based on their inability to independently complete the informed consent and research associated questionnaire.'}, 'identificationModule': {'nctId': 'NCT01159860', 'briefTitle': 'Is Cryosurgery or Curettage More Effective at Treating Seborrheic Keratoses?', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'Is Cryosurgery or Curettage More Effective at Treating Seborrheic Keratoses?', 'orgStudyIdInfo': {'id': 'IRB Protocol No. 33895'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cryosurgery', 'description': "One lesion on the patients' trunk or proximal extremities will be treated with cryosurgery.", 'interventionNames': ['Procedure: cryosurgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Curettage', 'description': "One lesion on one side of the patients' trunk or proximal extremities will be treated by curettage.", 'interventionNames': ['Procedure: Curettage']}], 'interventions': [{'name': 'cryosurgery', 'type': 'PROCEDURE', 'description': 'freezing of lesion with liquid nitrogen', 'armGroupLabels': ['Cryosurgery']}, {'name': 'Curettage', 'type': 'PROCEDURE', 'description': 'the lesion will be anesthetized and destroyed with a curette.', 'armGroupLabels': ['Curettage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Milton S. Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}], 'overallOfficials': [{'name': 'Lance D. Wood, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Milton S. Hershey Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}