Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-02-22 @ 4:13 AM
Study NCT ID:
NCT00999557
Status:
WITHDRAWN
Last Update Posted:
2020-07-31
First Post:
2009-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bimatoprost Ophthalmic Solution in Increasing Eyebrow and Eyelash Growth in Patients Who Have Undergone Chemotherapy for Breast Cancer and in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000505', 'term': 'Alopecia'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D018567', 'term': 'Breast Neoplasms, Male'}], 'ancestors': [{'id': 'D007039', 'term': 'Hypotrichosis'}, {'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study was never opened', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'lastUpdateSubmitDate': '2020-07-29', 'studyFirstSubmitDate': '2009-10-21', 'studyFirstSubmitQcDate': '2009-10-21', 'lastUpdatePostDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measuring regrowth of eyebrows and eyelashes by Bimatoprost Opthalmic solution', 'timeFrame': 'every 30 days for 4 months', 'description': 'Efficacy of Bimatoprost Opthalmic solution in expediting regrowth of eyebrows and eyelashes in patients who have undergone chemotherapy for breast cancer and in increasing eyebrow growth in healthy participants with no known underlying disease as assessed by two physicians and an aesthetics expert on a scale of 0-4.'}], 'secondaryOutcomes': [{'measure': 'Effectiveness of Bimatoprost Ophthalmic Solution as assessed by patient self-report on a scale of 0-4.', 'timeFrame': 'every 30 days for 4 months'}, {'measure': 'Psychological impact as assessed at baseline and at 6 months by patient-completed questionnaires', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['breast cancer', 'male breast cancer', 'alopecia'], 'conditions': ['Alopecia', 'Breast Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Bimatoprost ophthalmic solution may help increase eyebrow and eyelash growth in patients who have undergone chemotherapy.\n\nPURPOSE: This randomized clinical trial is studying how wells bimatoprost ophthalmic solution works in increasing eyebrow and eyelash growth in patients who have undergone chemotherapy for breast cancer and in healthy participants.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* To assess the effectiveness of bimatoprost ophthalmic solution in expediting regrowth of eyebrows and eyelashes in patients who have undergone chemotherapy for breast cancer and in increasing eyebrow growth in healthy participants with no known underlying disease as assessed by two physicians and an aesthetics expert on a scale of 0-4.\n\nSecondary\n\n* To assess the effectiveness of this treatment as assessed by patient self-report on a scale of 0-4.\n* To assess the psychological impact of this treatment as assessed by patient-completed questionnaires.\n\nOUTLINE: Patients are randomized to 1 of 2 intervention arms.\n\n* Arm I: Patients apply topical bimatoprost ophthalmic solution to base of upper eyelid margins OR to eyebrow region once daily for 4 months in the absence of unacceptable toxicity.\n* Arm II: Patients apply topical placebo solution to base of upper eyelid margins OR to eyebrow region once daily for 4 months in the absence of unacceptable toxicity.\n\nPatients complete questionnaires at baseline and monthly for 5 months about changes in eyebrows/eyelashes, side effects of treatment, and the psychological impact of treatment. Photographs of eyebrows or eyelashes and surrounding skin are taken at baseline and monthly for 5 months and reviewed by a physician and aesthetics expert.\n\nAfter completion of study treatment, patients are followed up at 1 month.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Meets 1 of the following criteria:\n* Diagnosis of breast cancer (group 1)\n* Completed chemotherapy within the past month that has resulted in eyebrow alopecia or eyelash hypotrichosis\n* Eyebrow score of 0-2 or eyelash score of 0-2 on the study's qualitative eyebrow or eyelash growth chart\n* Has no known underlying disease (group 2)\n* Desires thicker, fuller, or more numerous eyebrows\n\nExclusion criteria\n\n* pregnant\n* does not Speak a language adequately covered by study translator services\n* cognitive impairment\n* history of trauma or burn to the eyebrow region, alopecia areata, or trichotillomania\n* known diagnoses possibly underlying or contributing to the state of the eyebrows including, but not limited to, telogen effluvium or anagen effluvium (group 2)\n* active ocular disease (group 1)\n* thyroid hormone level abnormalities (group 2)\n* More than 2 years since prior ocular surgery (group 1)\n* prior topical medication for increasing eyebrow growth within 30 days od starting study treatment\n* concomitant chemotherapy for the treatment of cancer (group 1)\n* concomitant therapy for eyelash or eyebrow growth"}, 'identificationModule': {'nctId': 'NCT00999557', 'briefTitle': 'Bimatoprost Ophthalmic Solution in Increasing Eyebrow and Eyelash Growth in Patients Who Have Undergone Chemotherapy for Breast Cancer and in Healthy Participants', 'organization': {'class': 'OTHER', 'fullName': 'Jonsson Comprehensive Cancer Center'}, 'officialTitle': 'Efficacy of Topical Bimatoprost in Promoting Hair Growth in the Region of the Eyebrow and Eyelashes for Post-chemotherapy Patients Versus Normal Patients', 'orgStudyIdInfo': {'id': 'CDR0000657044'}, 'secondaryIdInfos': [{'id': 'UCLA-0904044'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I', 'description': 'Patients apply topical bimatoprost ophthalmic solution to base of upper eyelid margins OR to eyebrow region once daily for 4 months in the absence of unacceptable toxicity.', 'interventionNames': ['Drug: bimatoprost ophthalmic solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm II', 'description': 'Patients apply topical placebo solution to base of upper eyelid margins OR to eyebrow region once daily for 4 months in the absence of unacceptable toxicity.', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'bimatoprost ophthalmic solution', 'type': 'DRUG', 'description': 'Applied topically', 'armGroupLabels': ['Arm I']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Applied topically', 'armGroupLabels': ['Arm II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Jenny Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jonsson Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jonsson Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}