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

NCT00999557 | Withdrawn DMC

• 2 other identifiers: CDR0000657044UCLA-0904044
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Alopecia; Breast Cancer

Keywords

breast cancer; male breast cancer; alopecia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Effectiveness of Bimatoprost Ophthalmic Solution as assessed by patient self-report on a scale of 0-4.

  every 30 days for 4 months

• Psychological impact as assessed at baseline and at 6 months by patient-completed questionnaires

  6 months

Study Arms (2)

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.

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.

Drug: placebo

Interventions

bimatoprost ophthalmic solution DRUG

Applied topically

Arm I

placebo DRUG

Applied topically

Arm II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead

Study Sites (1)

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Alopecia; Breast Neoplasms; Breast Neoplasms, Male

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases

Study Officials

• Jenny Kim, MD, PhD

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2009
• First Posted: October 22, 2009
• Study Start: January 1, 2016
• Primary Completion: August 1, 2017
• Last Updated: July 31, 2020

Record last verified: 2016-04

Locations

US (1)