Bimatoprost Ophthalmic Solution in Increasing Eyebrow and Eyelash Growth in Patients Who Have Undergone Chemotherapy for Breast Cancer and in Healthy Participants

Study Overview
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Brief Summary
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RATIONALE: Bimatoprost ophthalmic solution may help increase eyebrow and eyelash growth in patients who have undergone chemotherapy. PURPOSE: 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.

Detailed Description
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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.

Official Title
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Efficacy of Topical Bimatoprost in Promoting Hair Growth in the Region of the Eyebrow and Eyelashes for Post-chemotherapy Patients Versus Normal Patients

Conditions
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Alopecia, Breast Cancer

Intervention / Treatment
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* Drug: bimatoprost ophthalmic solution
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meets 1 of the following criteria: Diagnosis of breast cancer (group 1) Completed chemotherapy within the past month that has resulted in eyebrow alopecia or eyelash hypotrichosis Eyebrow score of 0-2 or eyelash score of 0-2 on the study's qualitative eyebrow or eyelash growth chart Has no known underlying disease (group 2) Desires thicker, fuller, or more numerous eyebrows Exclusion criteria pregnant does not Speak a language adequately covered by study translator services cognitive impairment history of trauma or burn to the eyebrow region, alopecia areata, or trichotillomania known diagnoses possibly underlying or contributing to the state of the eyebrows including, but not limited to, telogen effluvium or anagen effluvium (group 2) active ocular disease (group 1) thyroid hormone level abnormalities (group 2) More than 2 years since prior ocular surgery (group 1) prior topical medication for increasing eyebrow growth within 30 days od starting study treatment concomitant chemotherapy for the treatment of cancer (group 1) concomitant therapy for eyelash or eyebrow growth

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>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. | Drug: bimatoprost ophthalmic solution<br>* Applied topically<br>|
| Placebo Comparator: Arm II<br>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. | Drug: placebo<br>* Applied topically<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring regrowth of eyebrows and eyelashes by Bimatoprost Opthalmic solution | 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. | every 30 days for 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of Bimatoprost Ophthalmic Solution as assessed by patient self-report on a scale of 0-4. |  | every 30 days for 4 months | 
| Psychological impact as assessed at baseline and at 6 months by patient-completed questionnaires |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, male breast cancer, alopecia