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

This study is not yet open for participant recruitment.
Verified August 2013 by Jonsson Comprehensive Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00999557
First received: October 21, 2009
Last updated: August 22, 2013
Last verified: August 2013
  Purpose

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 Intervention
Alopecia
Breast Cancer
Drug: bimatoprost ophthalmic solution
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome Measures:
  • Measuring regrowth of eyebrows and eyelashes by Bimatoprost Opthalmic solution [ Time Frame: every 30 days for 4 months ] [ Designated as safety issue: No ]
    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. [ Time Frame: every 30 days for 4 months ] [ Designated as safety issue: No ]
  • Psychological impact as assessed at baseline and at 6 months by patient-completed questionnaires [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: January 2014
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00999557

Locations
United States, California
University of California Los Angeles Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Jenny Kim, M.D.    310-825-5420      
Principal Investigator: Jenny Kim, M.D.         
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Principal Investigator: Jenny Kim, MD, PhD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00999557     History of Changes
Other Study ID Numbers: CDR0000657044, P30CA016042, UCLA-0904044
Study First Received: October 21, 2009
Last Updated: August 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Jonsson Comprehensive Cancer Center:
breast cancer
male breast cancer
alopecia

Additional relevant MeSH terms:
Hypotrichosis
Alopecia
Alopecia Areata
Breast Neoplasms
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Neoplasms by Site
Neoplasms
Breast Diseases
Bimatoprost
Cloprostenol
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 14, 2014