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

This study has been withdrawn prior to enrollment.
(Study was never opened)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00999557
First Posted: October 22, 2009
Last Update Posted: April 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
October 21, 2009
October 22, 2009
April 7, 2016
January 2016
August 2017   (Final data collection date for primary outcome measure)
Measuring regrowth of eyebrows and eyelashes by Bimatoprost Opthalmic solution [ Time Frame: every 30 days for 4 months ]
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.
Efficacy as assessed by 2 physicians and an aesthetics expert monthly
Complete list of historical versions of study NCT00999557 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Psychological impact as assessed at baseline and at 6 months by patient-completed questionnaires [ Time Frame: 6 months ]
  • Efficacy as assessed by the patients monthly
  • Psychological impact as assessed by patient-completed questionnaires at baseline and at 6 months
Not Provided
Not Provided
 
Bimatoprost Ophthalmic Solution in Increasing Eyebrow and Eyelash Growth in Patients Who Have Undergone Chemotherapy for Breast Cancer and in Healthy Participants
Efficacy of Topical Bimatoprost in Promoting Hair Growth in the Region of the Eyebrow and Eyelashes for Post-chemotherapy Patients Versus Normal Patients

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
  • Alopecia
  • Breast Cancer
  • Drug: bimatoprost ophthalmic solution
    Applied topically
  • Drug: placebo
    Applied topically
  • 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.
    Intervention: Drug: bimatoprost ophthalmic solution
  • 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.
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
August 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00999557
CDR0000657044
P30CA016042 ( U.S. NIH Grant/Contract )
UCLA-0904044
Yes
Not Provided
Not Provided
Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Jenny Kim, MD, PhD Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP