AlopeciaNCT00999557
Bimatoprost Ophthalmic Solution in Increasing Eyebrow and Eyelash Growth in Patients Who Have Undergone Chemotherapy for Breast Cancer and in Healthy Participants
A study testing bimatoprost ophthalmic solution in people with Alopecia and Breast Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alopecia, Breast Cancer
- What is being tested?
- bimatoprost ophthalmic solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Los Angeles
Los Angeles, California, 90095
About this study
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
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.
Read the 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.
- Conditions
- Alopecia, Breast Cancer
- Being tested
- bimatoprost ophthalmic solution, placebo
- Keywords
- breast cancer, male breast cancer, alopecia
- Medical subject headings
- Alopecia, Breast Neoplasms, Breast Neoplasms, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bimatoprost ophthalmic solutionDrug
Applied topically
placeboDrug
Applied topically
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | 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. Receives: Drug: bimatoprost ophthalmic solution |
| Arm II | Placebo comparator | 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. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: every 30 days for 4 months
Secondary outcomes (2)
Effectiveness of Bimatoprost Ophthalmic Solution as assessed by patient self-report on a scale of 0-4.
Measured: every 30 days for 4 months
Psychological impact as assessed at baseline and at 6 months by patient-completed questionnaires
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2009 (estimated)
- Study startJan 2016
- Primary completionAug 2017 (estimated)
Why it stopped: Study was never opened
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlopeciaStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jenny Kim, MD, PhD, Principal investigator, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999557
- Sponsor's protocol ID
- CDR0000657044
- Other IDs
- UCLA-0904044
- Status last verified
- Apr 2016
- First submitted
- 21 Oct 2009
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00999557
- Acronym / sponsor ID
- CDR0000657044
- Conditions
- Alopecia, Breast Cancer
- Keywords
- breast cancer, male breast cancer, alopecia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was never opened
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Aug 2017 (estimated)
- First posted
- 22 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: bimatoprost ophthalmic solutionPatients 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 | Placebo comparator | Drug: placeboPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bimatoprost ophthalmic solutionApplied topically | Drug | Arm I |
| placeboApplied topically | Drug | Arm II |
Primary outcome
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.
2 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jenny Kim, MD, PhD principal investigator
Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bimatoprost ophthalmic solution in people with Alopecia and Breast Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring regrowth of eyebrows and eyelashes by Bimatoprost Opthalmic solution (time frame: every 30 days for 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2020; AzTrials last refreshed its copy on 7 Nov 2026.