NCT06020586招募中不适用
Phase 2 Study to Evaluate the Efficacy and Safety of ECOHAIR Hair Lotion in the Accelerated Recovery of Chemotherapy-induced Alopecia.
Instituto de Oncología Ángel H. Roffo1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2022年6月6日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Time to event, defined as the time from the start of treatment to achieve 100% total hair coverage of the scalp.
研究概览
简要总结
This is a Phase 2, single-center study designed to determine the effect of ECOHAIR topical solution on scalp hair growth evaluated objectively ( images) and subjectively ( patient and investigator reports). A total of 22 subjects are planned to be enrolled, 15 in a prospective single-arm phase in which they will receive the study treatment and 7 controls. Patients should have a clinical diagnosis of chemotherapy-induced alopecia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women diagnosed with stage I to III breast/ovarian cancer aged 18 to 65 years.
- •Receiving chemotherapeutic agents containing taxanes and/or anthracyclines.
- •Willing to agree to shave thinning hair at baseline.
- •Willingness to be photographed and consent to photographic disclosure.
- •Able to understand and willing to sign an informed consent form.
- •Willing and able to follow all study instructions and attend all study visits.
- •Subjects taking thyroid replacement medication must be on stable doses for 6 months prior to enrollment and remain on the same maintenance dose throughout the study.
- •If female of childbearing age, must have a negative serum or urine pregnancy test at screnning (visit 0). Use a highly effective method of contraception during the study; do not plan a pregnancy for the duration of the study.
排除标准
- •Use of any products or devices used to promote scalp hair growth (e.g., finasteride or minoxidil, L-tyrosine, cold caps).
- •Sensitivity or allergy to any ingredient in the Ecohair product.
- •Active skin disease on the scalp (such as psoriasis or seborrheic dermatitis) or history of skin disease on the scalp that, in the opinion of the investigator, may interfere with the efficacy or safety evaluations of the study.
- •Active scalp trauma or other condition affecting the scalp that, in the opinion of the investigator may interfere with the conduct of the study or evaluations.
- •The presence of a permanent or difficult to remove hairpiece or wig that, in the opinion of the investigator, will interfere with study evaluations if not removed at each visit.
- •Failure to be able to perform assigned clinical visits.
研究组 & 干预措施
hair lotion
Experimental
干预措施: hair lotion (Other)
结局指标
主要结局
Time to event, defined as the time from the start of treatment to achieve 100% total hair coverage of the scalp.
时间窗: baseline-30 days
Percentage of scalp surface area covered at 30 days.
时间窗: 30 days
The primary efficacy assessment is hair count in the target area (in a 1 cm2 circular area) using trichoscopy imaging.
次要结局
- Incidence and severity of local skin reactions. severity according to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0)(baseline- 60 days)
- Scalp hair density at 30 days.(30 days)
- Subject satisfaction questionnare.(baseline-30 days)
研究者
研究点 (1)
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