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

NCT ID: NCT00999557

Last Updated: 2020-07-31

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31

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.

Conditions

Alopecia; Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

bimatoprost ophthalmic solution

Intervention Type: DRUG

Applied topically

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.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Applied topically

Interventions

bimatoprost ophthalmic solution

Applied topically

Intervention Type: DRUG

placebo

Applied topically

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jenny Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Jonsson Comprehensive Cancer Center

Locations

University of California Los Angeles

Los Angeles, California, United States

Countries

United States

Other Identifiers

UCLA-0904044

Identifier Type: -

Identifier Source: secondary_id

CDR0000657044

Identifier Type: -

Identifier Source: org_study_id