Bimatoprost Ophthalmic Solution in Increasing Eyebrow and Eyelash Growth in Patients Who Have Undergone Chemotherapy for Breast Cancer and in Healthy Participants
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ClinicalTrials.gov Identifier: NCT00999557 |
Recruitment Status :
Withdrawn
(Study was never opened)
First Posted : October 22, 2009
Last Update Posted : July 31, 2020
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alopecia Breast Cancer | Drug: bimatoprost ophthalmic solution Drug: placebo | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Supportive Care |
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 Start Date : | January 2016 |
Estimated Primary Completion Date : | August 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: 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.
|
Drug: bimatoprost ophthalmic solution
Applied topically |
Placebo Comparator: 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.
|
Drug: placebo
Applied topically |
- Measuring regrowth of eyebrows and eyelashes by Bimatoprost Opthalmic solution [ Time Frame: every 30 days for 4 months ]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.
- Effectiveness of Bimatoprost Ophthalmic Solution as assessed by patient self-report on a scale of 0-4. [ Time Frame: every 30 days for 4 months ]
- Psychological impact as assessed at baseline and at 6 months by patient-completed questionnaires [ Time Frame: 6 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00999557
United States, California | |
University of California Los Angeles | |
Los Angeles, California, United States, 90095 |
Principal Investigator: | Jenny Kim, MD, PhD | Jonsson Comprehensive Cancer Center |
Responsible Party: | Jonsson Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT00999557 |
Other Study ID Numbers: |
CDR0000657044 UCLA-0904044 |
First Posted: | October 22, 2009 Key Record Dates |
Last Update Posted: | July 31, 2020 |
Last Verified: | April 2016 |
breast cancer male breast cancer alopecia |
Breast Neoplasms Alopecia Alopecia Areata Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Hypotrichosis Hair Diseases Pathological Conditions, Anatomical Bimatoprost Ophthalmic Solutions Pharmaceutical Solutions Antihypertensive Agents |