Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2026-03-28 @ 6:36 PM
Study NCT ID:
NCT02670603
Status:
COMPLETED
Last Update Posted:
2017-04-28
First Post:
2016-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of Evonail® Solution for Prevention or Treatment of Onycholysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'This study is open-labeled study. But outcome would be assessed the statistician who did not involve this study with blind data.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-26', 'studyFirstSubmitDate': '2016-01-28', 'studyFirstSubmitQcDate': '2016-02-01', 'lastUpdatePostDateStruct': {'date': '2017-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of onycholysis Gr 2 or more', 'timeFrame': '12weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Docetaxel Chemotherapy']}, 'referencesModule': {'references': [{'pmid': '28488142', 'type': 'DERIVED', 'citation': 'Kim JY, Ok ON, Seo JJ, Lee SH, Ahn JS, Im YH, Park YH. A prospective randomized controlled trial of hydrating nail solution for prevention or treatment of onycholysis in breast cancer patients who received neoadjuvant/adjuvant docetaxel chemotherapy. Breast Cancer Res Treat. 2017 Aug;164(3):617-625. doi: 10.1007/s10549-017-4268-7. Epub 2017 May 9.'}]}, 'descriptionModule': {'briefSummary': 'This study is a prospective randomized controlled study of EVONAIL® solution for prevention or treatment of onycholysis in patients with breast cancer receiving docetaxel chemotherapy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with breast cancer receiving adjuvant/neoadjuvant docetaxel chemotherapy\n\nExclusion Criteria:\n\n* Patients with breast cancer receiving palliative docetaxel chemotherapy\n* Patients having onycholysis before docetaxel treatment'}, 'identificationModule': {'nctId': 'NCT02670603', 'briefTitle': 'A Trial of Evonail® Solution for Prevention or Treatment of Onycholysis', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'A Prospective Randomized Controlled Trial of Evonail® Solution for Prevention or Treatment of Onycholysis in Breast Cancer Patients Who Received Neoadjuvant/Adjuvant Docetaxel Chemotherapy', 'orgStudyIdInfo': {'id': '2015-04-018-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental arm', 'description': 'In experimental arm, each patient painted EVONAIL® solution on nails and periungual areas once a day till developing onycholysis grade 2 or more.', 'interventionNames': ['Drug: EVONAIL® solution']}, {'type': 'OTHER', 'label': 'Control arm', 'description': 'In control arm, each patient painted EVONAIL® solution on nails and periungual area twice a day after developing onycholysis grade 2.\n\nThis study design allowed cross-over. Therefore, this control arm would give EVONAIL® solution after developing onlycholysis grade 2 in spite of control arm.', 'interventionNames': ['Drug: EVONAIL® solution']}], 'interventions': [{'name': 'EVONAIL® solution', 'type': 'DRUG', 'otherNames': ['Hydrating Nail Solution'], 'armGroupLabels': ['Control arm', 'Experimental arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD,Ph.D', 'investigatorFullName': 'Yeon Hee Park', 'investigatorAffiliation': 'Samsung Medical Center'}}}}