Hair Repigmentation in Patients Undergoing on Cerebrolysin Treatment for Neurological Diseases.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Evaluation of scalp melanocytes function.
研究概览
简要总结
Open-label histological study of scalp biopsies from patients undergoing treatment with Cerebrolysin as therapy for cerebrovascular disease. The aim is to assess by histological techniques the causes of follicular repigmentation that occurs during the Cerebrolysin treatment.
详细描述
Patients who fulfill the study requirements will receive the standard Cerebrolysin protocol as follows: Intravenous (iv) infusions of 5 vials per week, 2 vials on Mondays and 3 vials on Thursdays for 4 weeks, followed by an 8-week resting period prior to the next cycle of treatment. Each patient will receive 3 cycles giving a total of 9 months of follow-up. For intravenous infusions, each 10 ml vial containing 215.2mg / ml of Cerebrolysin (Ever Pharma) is diluted with physiological saline solution (NaCI 0.9%) to a final volume of 100 mL.
A pre- and post-treatment biopsies will be collected from the achromotrichia area of each patient. Antisepsis of the area will be performed prior to each biopsy with chlorhexidine, followed by local anesthesia with lidocaine 2% and epinephrine. The biopsy will be collected using a 4mm punch and the wound will be sutured with non-absorbable stitches with Prolene 4-0.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Known neurologist prescription for Cerebrolysin treatment due ischemic or hemorrhagic stroke, traumatic brain injury or dementia.
- •Age-related white or gray hair.
- •Above 40 years old
- •Voluntarily consents in written informed consent by the principal or legal representative
排除标准
- •Patients with a diagnosis of Chronic Kidney Disease (CKD).
- •Known history of seizures, epilepsy, or hypersensitivity to one or any drug components.
- •Pregnant patients.
- •Patients with a history of recent treatment of hair coloring products.
研究组 & 干预措施
Hair repigmentation during Cerebrolysin treatment for neurological diseases
Patients prescribed for Cerebrolysin treatment due neurological diseases.
干预措施: Cerebrolysin (Drug)
结局指标
主要结局
Evaluation of scalp melanocytes function.
时间窗: From the beginning of the treatment until 9th month.
Change in melanocyte function activity measured by immunostaining score.
Microscopic evaluation of scalp repigmentation
时间窗: From the beginning of the treatment until 9th month.
Change in melanin production in the scalp measured by histochemical staining score.
Macroscopic evaluation of scalp repigmentation
时间窗: From the beginning of the treatment until 9th month.
Change in scalp pigmentation throughout cerebrolysin treatment measured by gray/white hair score.
次要结局
未报告次要终点
研究者
Roberto Montes de Oca Luna
Principal Investigator
Universidad Autonoma de Nuevo Leon
