Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-02 @ 1:21 AM
Study NCT ID:
NCT01097850
Status:
WITHDRAWN
Last Update Posted:
2014-12-12
First Post:
2010-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topical Henna Preparation for the Treatment of Hand Foot Skin Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D060831', 'term': 'Hand-Foot Syndrome'}], 'ancestors': [{'id': 'D003875', 'term': 'Drug Eruptions'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D004342', 'term': 'Drug Hypersensitivity'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No subject accrual.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-11', 'studyFirstSubmitDate': '2010-03-31', 'studyFirstSubmitQcDate': '2010-04-01', 'lastUpdatePostDateStruct': {'date': '2014-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '• To compare the severity of HFS in subjects receiving topical natural henna paste treatment along with using CeraVe™ moisturizing cream concurrently on the treatment side and using only CeraVe™ moisturizing cream on the control side.', 'timeFrame': '3 weeks'}], 'secondaryOutcomes': [{'measure': 'To examine quality of life, comparing natural henna treatment versus CeraVe™ alone, using the Skindex-16 questionnaire', 'timeFrame': '3 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hand foot skin syndrome', 'palmar plantar erythrodysesthesia', 'doxorubicin', 'capecitabine'], 'conditions': ['Hand Foot Skin Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether henna paste is effective in the treatment of hand-foot skin syndrome, induced by the drugs Capecitabine and pegylated liposomal doxorubicin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients receiving capecitabine and/or pegylated liposomal doxorubicin as monotherapy or in combination with other agents\n* New diagnosis of active hand-foot skin reaction (on bilateral hands and/or bilateral feet) of 1-3 toxicity as defined by the NCI-CTCAE version 4.0 grading scale with onset of symptoms within the last thirty days\n* Patients must be 18 years or older\n* Patients must provide written informed consent to participate in the study\n\nExclusion Criteria:\n\n* Patients with pre-existing dermatological condition affecting the hands or feet that may limit the interpretation of results\n* Known allergy to natural henna\n* Patients with a previous history of HFS\n* History of G6PD deficiency as determined by screening bloodwork'}, 'identificationModule': {'nctId': 'NCT01097850', 'briefTitle': 'Topical Henna Preparation for the Treatment of Hand Foot Skin Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Prospective Randomized Controlled Open-label Trial of a Topical Henna Preparation for the Treatment of Hand-Foot Skin Syndrome and Its Associated Symptoms', 'orgStudyIdInfo': {'id': 'NU 09D1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Right', 'description': 'Application of henna paste to right hand/foot plus CeraVe moisturizer', 'interventionNames': ['Drug: henna paste']}, {'type': 'OTHER', 'label': 'Left', 'description': 'Application of henna paste to the left hand/foot plus CeraVe moisturizer', 'interventionNames': ['Drug: henna paste']}], 'interventions': [{'name': 'henna paste', 'type': 'DRUG', 'description': 'Henna paste will be applied to either the left hand/foot or right hand/foot, along with CeraVe moisturizer to both hands/feet', 'armGroupLabels': ['Left', 'Right']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Peter Lio, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor in Dermatology and Pediatrics', 'investigatorFullName': 'Dennis West', 'investigatorAffiliation': 'Northwestern University'}}}}