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”

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.

Study Type: Interventional

Study Design: Supportive Care, Randomized, Double-Blind, Placebo Control

Study Primary Completion Date: March 2010

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• 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.
• 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.

Primary Measures

• Efficacy of bimatoprost ophthalmic solution as assessed monthly by two physicians and an aesthetics expert
  • Safety Issue?: No

Secondary Measures

• Efficacy of bimatoprost ophthalmic solution as assessed monthly by patient-completed questionnaires
  • Safety Issue?: No
• Psychological impact as assessed at baseline and at 6 months by patient-completed questionnaires
  • Safety Issue?: No

DISEASE CHARACTERISTICS:

• 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
• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• Menopausal status not specified
• Not pregnant
• Speaks a language adequately covered by study translator services
• No cognitive impairment
• No history of trauma or burn to the eyebrow region, alopecia areata, or trichotillomania
• No other known diagnoses possibly underlying or contributing to the state of the eyebrows including, but not limited to, telogen effluvium or anagen effluvium (group 2)
• No active ocular disease (group 1)
• No known thyroid hormone level abnormalities (group 2)

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• More than 2 years since prior ocular surgery (group 1)
• At least 30 days since prior topical medication for increasing eyebrow growth
• No concurrent chemotherapy for the treatment of cancer (group 1)
• No other concurrent therapy for eyelash or eyebrow growth

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Jonsson Comprehensive Cancer Center

Overall Clinical Trial Officials and Contacts

Jenny Kim, MD, PhD Principal Investigator Jonsson Comprehensive Cancer Center  

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00999557

Study ID Number: CDR0000657044

ClinicalTrials.gov Identifier: NCT00999557

Health Authority: Unspecified

Clinical trial summary from the National Cancer Institute's PDQ® database