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Trial: NCT00999557 [RDF]

Label NCT00999557
Slug nct00999557
Trialid NCT00999557
Lookup name NCT00999557
Provenance http://clinicaltrials.gov/show/NCT00999557?displayxml=true
Lastchanged date May 27, 2014
Firstreceived results date
Firstreceived date October 21, 2009
Id info nct id NCT00999557
Overall status Not yet recruiting
Id info secondary id P30CA016042
Biospec retention
Required header link text Link to the current ClinicalTrials.gov record.
Enrollment 90
Number of arms 2
Is section 801 No
Is fda regulated Yes
Brief title Bimatoprost Ophthalmic Solution in Increasing Eyebrow and Eyelash Growth in Patients Who Have Undergone Chemotherapy for Breast Cancer and in Healthy Participants
Acronym
Official title Efficacy of Topical Bimatoprost in Promoting Hair Growth in the Region of the Eyebrow and Eyelashes for Post-chemotherapy Patients Versus Normal Patients
Study type Interventional
Id info nct alias
Completion date
Verification date May 2014
Why stopped
Id info org study id CDR0000657044
Required header url http://clinicaltrials.gov/show/NCT00999557
Study design Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Source Jonsson Comprehensive Cancer Center
Primary completion date August 2015
Brief summary
Number of groups
Required header download date ClinicalTrials.gov processed this data on August 26, 2014
Phase N/A
Start date January 2015
Has expanded access No
Biospec descr
Detailed description OBJECTIVES: Primary - 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. Secondary - To assess the effectiveness of this treatment as assessed by patient self-report on a scale of 0-4. - To assess the psychological impact of this treatment as assessed by patient-completed questionnaires. OUTLINE: Patients are randomized to 1 of 2 intervention arms. - 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. - 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. Patients 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. After completion of study treatment, patients are followed up at 1 month.
Condition browse 6c2449a965f9f5e3d63f35de368c6887
Intervention browse c05b238d9c59bd9ff11ad537b18829dd
Responsible party 015b495dfd0be1a85fcb46d41f363abd
Overall contact None
Overall contact backup None
Sponsor group 6acc1bc361d1e8ec106937eefa00155a
Oversight info United States: Institutional Review Board (Oversight_info)
Eligibility f3a56f90b2c406b1b165045825cb4dcb
Keywords alopecia, breast cancer, male breast cancer
Conditions Alopecia, Breast Cancer
Locations 946c391cb4626b7f0560b892d48e31aa
Links http://cancer.gov/clinicaltrials/UCLA-0904044
Results references None
Arm groups Arm II (Arm Group), Arm I (Arm Group)
Location countries United States
Interventions bimatoprost ophthalmic solution (Intervention), placebo (Intervention)
Secondary outcomes 4fb39ec506dee3c1d6703b3e0e6c8bd6, 8eb0c5f3fa5a262fbc4f8b3062c2690a
References None
Primary outcomes e4c61b507bcaa614d946c83b20165fdf
Removed countries None
Overall officials a7b533adaeb7ea80126286bdaa86510a