Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-29 @ 11:30 PM
Study NCT ID:
NCT01200251
Status:
COMPLETED
Last Update Posted:
2014-07-16
First Post:
2010-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Bimatoprost Gel on Eyelash Growth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007039', 'term': 'Hypotrichosis'}], 'ancestors': [{'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069580', 'term': 'Bimatoprost'}], 'ancestors': [{'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003008', 'term': 'Cloprostenol'}, {'id': 'D011461', 'term': 'Prostaglandins F, Synthetic'}, {'id': 'D011465', 'term': 'Prostaglandins, Synthetic'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-14', 'studyFirstSubmitDate': '2010-09-10', 'studyFirstSubmitQcDate': '2010-09-10', 'lastUpdatePostDateStruct': {'date': '2014-07-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'eyelash length', 'timeFrame': '6 months', 'description': 'eyelash ruler used to measure eyelash length'}], 'secondaryOutcomes': [{'measure': 'eyelash pigment', 'timeFrame': '6 mos', 'description': 'blinded grader used digital photos to grade degree of pigment on scale of 1-5'}, {'measure': 'eyelash thickness', 'timeFrame': '6 mos', 'description': 'blinded grader used digital photos to grade degree of thickness on scale of 1-5'}, {'measure': 'eyelash amount', 'timeFrame': '6 mos', 'description': 'blinded grader used digital photos to grade degree of amount by counting lashes'}, {'measure': 'eyelash side effects', 'timeFrame': '6 mos', 'description': 'any side effects (irritation, allergy, iop change, visual acuity, macular edema, uveitis, iris color change, etc... were assessed'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Madarosis', 'Hypotrichosis']}, 'referencesModule': {'references': [{'pmid': '15577756', 'type': 'RESULT', 'citation': 'Tosti A, Pazzaglia M, Voudouris S, Tosti G. Hypertrichosis of the eyelashes caused by bimatoprost. J Am Acad Dermatol. 2004 Nov;51(5 Suppl):S149-50. doi: 10.1016/j.jaad.2004.05.002.'}]}, 'descriptionModule': {'briefSummary': 'A internally controlled, single-blinded, randomized controlled trial to investigate the use of Bimatoprost eyelash gel on eyelash growth and appearance in breast cancer patients who suffer from madarosis (loss of eyelashes) due to the side effects of chemotherapy. IND and IRB approval have been obtained.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-80 YO females\n* madarosis or hypotrichosis (loss of eyelashes) due to chemotherapy used to treat breast cancer\n* only breast cancer patients\n\nExclusion Criteria:\n\n* inability to follow up, apply gel\n* active eye/eyelid infection or inflammatory process\n* cancer not related to breast cancer, healthy patients\n* males'}, 'identificationModule': {'nctId': 'NCT01200251', 'briefTitle': 'Study of Bimatoprost Gel on Eyelash Growth', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'The Role of Bimatoprost Eyelash Gel in Chemotherapy-induced Madarosis: an Analysis of Efficacy and Safety', 'orgStudyIdInfo': {'id': '9459'}, 'secondaryIdInfos': [{'id': '71320', 'type': 'REGISTRY', 'domain': 'IND'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bimatoprost treated eyelid', 'description': 'one eyelid of the patient was randomized to the treatment arm and given the gel to use', 'interventionNames': ['Drug: Bimatoprost eyelash gel']}, {'type': 'NO_INTERVENTION', 'label': 'control arm - no gel', 'description': 'the other fellow eyelid of the patient did not receive any treatment until month 4 and the patient crossed over to treating both eyelids'}], 'interventions': [{'name': 'Bimatoprost eyelash gel', 'type': 'DRUG', 'otherNames': ['lumigan'], 'description': 'Bimatoprost 0.03% solution was compounded into a gel - patients used on eyelash margin once daily placing gel with a fingertip or Q-tip for 6 months', 'armGroupLabels': ['Bimatoprost treated eyelid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}