1-Year Double-Blind Placebo-Controlled Study To EVALUATE THE EFFECT OF AGE ZERO™ EXOSOMES ON HAIR REGROWTH IN HEALTHY MEN AND WOMEN WITH ANDROGENETIC ALOPECIA
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Hair count
研究概览
简要总结
The purpose of this study is to determine whether Wharton's Jelly mesenchymal stem cell-derived exosome microneedling on the scalp is an effective treatment for Androgenetic Alopecia (pattern hair loss).
详细描述
After being informed about the study and potential risks, all participants who give written consent and meet the later discussed inclusion criteria and don't fall under the exclusion criteria will be enrolled in the study.
The investigators will conduct a double-blind placebo-controlled study to test whether Wharton's Jelly Mesenchymal Stem Cell-derived Exosome (WJMSC-exosome) application with microneedling is an effective treatment for Androgenetic Alopecia. Participants will be broken down into a 5 billion exosome group vs. saline group and a 50 billion exosome vs. saline group.
Treatment will be applied to the following treatment area: two rectangles on the scalp vertex each measuring 4cm on the sagittal plane by 2cm on the coronal plane. One rectangle will be 2.0 mm left of the midline of the scalp and another will be 2.0 mm right of the midline of the scalp. Each treatment area will be divided into an anterior and posterior half with 1 permanent microdot tattoo in the middle (4 tattoos in total). The microdot tattoo (composed of Iron Oxide, Glycerol, Alcohol, and distilled Water and Red - D&C Red #30, Glycerol, Alcohol and distilled water) will allow HairMatrix® by Canfield, an AI-driven hair consultation device, to accurately and reproducibly access changes in hair growth in the treatment areas.
Participants in the 5 billion exosome group will receive topical applications of 5 billion WJMSC-exosomes on one side of the treatment area and an equal volume of placebo (an identically-looking saline solution) application on the opposite side of the treatment area.
The 50 billion exosome group will receive topical applications of 50 billion WJMSC-exosomes on one side of the treatment area and an equal volume of placebo application on the opposite side of the treatment area.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Participant is experiencing hair loss and is diagnosed with Androgenetic Alopecia.
排除标准
- •Patients cannot have taken any medications, therapies, or treatment modalities of any kind to treat hair loss in the last six months.
- •Patients cannot have open wounds, eczema, or psoriatic plaques on the treatment area of the scalp.
- •Patients who are undergoing or have undergone chemotherapy and or radiation therapy within the past 6 months
- •Patients with a history of an autoimmune bullous disorder (having auto-antibodies to Dsg-1 or Dsg-3)
- •Patients who are currently immunocompromised or have a low white count making patients prone to infections.
结局指标
主要结局
Hair count
时间窗: Evaluated on monthly visits for a year
Evaluated by HairMatrix® by Canfield, an AI-driven hair consultation device
Hair thickness
时间窗: Evaluated on monthly visits for a year
Evaluated by HairMatrix® by Canfield, an AI-driven hair consultation device
Hair color
时间窗: Evaluated on monthly visits for a year
Evaluated by HairMatrix® by Canfield, an AI-driven hair consultation device
次要结局
- Adverse events(Participants will self-report adverse events during monthly visits for the entire 1-year duration)
- Self-reported hair changes(Patients will self-report on questionnaire during monthly visits for the entire 1-year duration)