NCT06477172招募中不适用
A Multi-site, Prospective, Observational Study of Autologous Hair Follicle Secretome (aHFS) as an Adjunct to Medical Aesthetic Procedures
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 60
- 主要终点
- Post-Procedure Symptoms
研究概览
简要总结
Non-interventional, multi-site, prospective, open-label, observational, real-world study of autologous hair follicle secretome use.
详细描述
This non-interventional, observation study is to collect real-world data on the use of an autologous, hair follicle derived secretome topical cosmetic product following various medical aesthetic procedures.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Male and Female
- •Ages: 18-60
- •Any Fitzpatrick skin type
- •Planning a medical aesthetic procedure
- •For subjects receiving hair procedures (closed to enrollment):
- •Androgenic alopecia
- •Traction alopecia
- •Scarring alopecia
- •Stable use of any medication or supplement for hair loss, including finasteride, any other 5 α-reductase inhibitor, minoxidil, steroids, or hormonal products, during the 3 months prior to enrollment in the study is allowed.
- •No intention to start new hair growth medications or change dose of hair growth medications from the time of consent through the end of the study follow-up period.
- •Undergoing one of the following medical aesthetic procedures:
- •Laser resurfacing of the face (ablative or non-ablative) or Ellacor of the face (Ellacor closed to enrollment)
- •Tixel of the face
- •Keralase of the scalp (scalp treatment closed to enrollment)
- •Acne Scars and Surgery scars, either old or new as long as old scars are also being treated with ablative or non-ablative laser or microneedling (e.g. abdominoplasty, breast reduction/ reconstruction/enhancement, post-weight loss, etc.
- •Planning to use Acorn Autologous Hair Follicle Secretome cosmetic product
排除标准
- •Pregnant or Breastfeeding
- •Participation in an interventional clinical trial in the last 30 days
- •Use of other topical cosmetic products that may confound results
- •Use of retinoids within 7 days prior to facial procedure
- •For those receiving hair treatment, must not have had a hair transplant in the treatment area within the past 12 months
- •Any health condition that in the investigator's opinion should preclude participation in study
结局指标
主要结局
Post-Procedure Symptoms
时间窗: 1-7 days
Symptoms of redness, swelling, oozing, pain, tenderness, crusting, itching and discoloration will be measured using a 1-10 likert scale with 0 being best possible and 10 being worst imaginable.
Downtime Questionnaire
时间窗: 1-7 days
Questionnaire asking what activities would they have done, if it were not for their face appearance. Date of end of downtime captured.
次要结局
未报告次要终点
研究者
研究点 (60)
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