Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-29 @ 5:55 PM
Study NCT ID:
NCT01349556
Status:
WITHDRAWN
Last Update Posted:
2014-04-23
First Post:
2011-05-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Drug Rash From Certain Cancer Therapies Using Tretinoin Cream
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014212', 'term': 'Tretinoin'}], 'ancestors': [{'id': 'D014801', 'term': 'Vitamin A'}, {'id': 'D012176', 'term': 'Retinoids'}, {'id': 'D002338', 'term': 'Carotenoids'}, {'id': 'D011090', 'term': 'Polyenes'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study withdrawn due to volunteer disinterest in participating.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-21', 'studyFirstSubmitDate': '2011-05-05', 'studyFirstSubmitQcDate': '2011-05-05', 'lastUpdatePostDateStruct': {'date': '2014-04-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EGFRi rash severity', 'timeFrame': '8 weeks'}]}, 'conditionsModule': {'keywords': ['cancer', 'chemotherapy', 'EGFR inhibitors', 'tretinoin', 'EGFRi drug rash'], 'conditions': ['Medication Reaction']}, 'descriptionModule': {'briefSummary': "This research is being done to study whether using of topical tretinoin can help prevent the common rash that patients often get while taking epidermal growth factor inhibitor (EGFR-I) medications such ascetuximab or erlotinib.\n\nPatients taking EGFR-I medications often develop skin irritation and acne-like bumps on their face, chest, and other areas. This rash from EGFR-I's is often treated with moisturizers and topical or oral antibiotics. However, there has not yet been a study looking at a way to prevent this common side effect from occurring, and topical tretinoin may be useful in reducing the rash.\n\nTretinoin 0.025% cream is approved by the Food and Drug Administration (FDA) for the treatment of acne, acne scarring, and photodamage. It is not approved for use in preventing rashes associated with EGFR-I's."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or over\n* Scheduled to begin treatment with an EGFR inhibitor drug\n\nExclusion Criteria:\n\n* Pregnant or nursing\n* History of bleeding disorder\n* History of keloids or large, thick, puffy-looking scars in the last 10 years\n* Used topical retinoids in the last year (e.g. tretinoin/Retin-A, adapalene/Differin, tazarotene/Tazorac)'}, 'identificationModule': {'nctId': 'NCT01349556', 'briefTitle': 'Prevention of Drug Rash From Certain Cancer Therapies Using Tretinoin Cream', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Prevention of Epidermal Growth Factor Receptor Inhibitor-Associated Dermatologic Toxicities by Pre-treatment With Topical Tretinoin', 'orgStudyIdInfo': {'id': 'NA_00042104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tretinoin pre-treatment', 'interventionNames': ['Drug: Tretinoin']}], 'interventions': [{'name': 'Tretinoin', 'type': 'DRUG', 'description': 'tretinoin 0.025% cream', 'armGroupLabels': ['Tretinoin pre-treatment']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Anna L Chien, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins Dermatology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Co-Director, Cutaneous Translational Research Program', 'investigatorFullName': 'Anna Chien', 'investigatorAffiliation': 'Johns Hopkins University'}}}}