Efficacy of Topical Bimatoprost in Promoting Hair Growth in the Region of the Eyebrow and Eyelashes for Post-chemotherapy Patients Versus Normal Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Measuring regrowth of eyebrows and eyelashes by Bimatoprost Opthalmic solution
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •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
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: bimatoprost ophthalmic solution (Drug)
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.
干预措施: placebo (Drug)
结局指标
主要结局
Measuring regrowth of eyebrows and eyelashes by Bimatoprost Opthalmic solution
时间窗: 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.
次要结局
- Psychological impact as assessed at baseline and at 6 months by patient-completed questionnaires(6 months)
- Effectiveness of Bimatoprost Ophthalmic Solution as assessed by patient self-report on a scale of 0-4.(every 30 days for 4 months)