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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

Primary Purpose

Alopecia, Breast Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
bimatoprost ophthalmic solution
placebo
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Alopecia focused on measuring breast cancer, male breast cancer, alopecia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of California Los Angeles

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm I

Arm II

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Effectiveness of Bimatoprost Ophthalmic Solution as assessed by patient self-report on a scale of 0-4.
Psychological impact as assessed at baseline and at 6 months by patient-completed questionnaires

Full Information

First Posted
October 21, 2009
Last Updated
July 29, 2020
Sponsor
Jonsson Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00999557
Brief Title
Bimatoprost Ophthalmic Solution in Increasing Eyebrow and Eyelash Growth in Patients Who Have Undergone Chemotherapy for Breast Cancer and in Healthy Participants
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

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Study was never opened
Study Start Date
January 2016 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia, Breast Cancer
Keywords
breast cancer, male breast cancer, alopecia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
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 Title
Arm II
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
bimatoprost ophthalmic solution
Intervention Description
Applied topically
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Applied topically
Primary Outcome Measure Information:
Title
Measuring regrowth of eyebrows and eyelashes by Bimatoprost Opthalmic solution
Description
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.
Time Frame
every 30 days for 4 months
Secondary Outcome Measure Information:
Title
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
Title
Psychological impact as assessed at baseline and at 6 months by patient-completed questionnaires
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jenny Kim, MD, PhD
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

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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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