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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00999557
• Other study ID #: CDR0000657044
• Secondary ID: UCLA-0904044
• Status: Withdrawn
• Phase: N/A
• Start date: January 2016

Study information

• Verified date: April 2016
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 for breast cancer and in healthy participants.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• bimatoprost ophthalmic solution
Applied topically
• placebo
Applied topically

Locations

Country	Name	City	State
United States	University of California Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	every 30 days for 4 months
Secondary	Effectiveness of Bimatoprost Ophthalmic Solution as assessed by patient self-report on a scale of 0-4.		every 30 days for 4 months
Secondary	Psychological impact as assessed at baseline and at 6 months by patient-completed questionnaires		6 months