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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Recruitment Status : Withdrawn (Study was never opened)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
Sponsor:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Study Description
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Brief 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 for breast cancer and in healthy participants.


Condition or disease Intervention/treatment Phase
Alopecia Breast Cancer Drug: bimatoprost ophthalmic solution Drug: placebo Not Applicable

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
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Bimatoprost

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
  2. Psychological impact as assessed at baseline and at 6 months by patient-completed questionnaires [ Time Frame: 6 months ]

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

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, California
University of California Los Angeles
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
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Principal Investigator: Jenny Kim, MD, PhD Jonsson Comprehensive Cancer Center
More Information
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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
Keywords provided by Jonsson Comprehensive Cancer Center:
breast cancer
male breast cancer
alopecia
Additional relevant MeSH terms:
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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