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 February 2013 by Jonsson Comprehensive Cancer Center
Sponsor:
Jonsson Comprehensive Cancer Center
Collaborator:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00999557
First received: October 21, 2009
Last updated: February 11, 2013
Last verified: February 2013
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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:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Bimatoprost
U.S. FDA Resources
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: | September 2013 |
| 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: | February 11, 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 May 19, 2013