A Split-Scalp Study Evaluating the Efficacy and Safety of Fractional Laser Therapy With and Without Exosomes in the Treatment of Androgenetic Alopecia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in hair density (d84)
研究概览
简要总结
This trial aims to evaluate the efficacy, safety, and tolerability of fractional laser combined with topical exosome for hair regrowth in patients with androgenetic alopecia.
This study is expected to recruit 30 participants. The experimental group will receive fractional laser treatment combined with human umbilical cord mesenchymal stem cell exosome solution; the control group will receive fractional laser treatment combined with a placebo. Participants will receive three fractional laser treatments and will be followed up for 6 months. At each follow-up visit, hair density, diameter, vellus hair to terminal hair ratio, and adverse reactions will be assessed using trichotomy; a global photographic assessment will be performed using standardized imaging equipment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male pattern baldness diagnosed according to the Norwood-Hamilton classification III-V
- •Males aged 18 to 50 years
- •Willing to provide written informed consent and possessing the ability to read, write, speak, and understand
- •Able to follow the study's treatment guidelines
排除标准
- •Those who have taken oral Finasteride, Dutasteride, or Minoxidil within 6 months prior to the start of the trial.
- •Those who have used any topical or systemic medications that may affect hair growth within 6 months prior to the start of the trial.
- •Those who have received phototherapy, laser therapy, exosome therapy, or hair regrowth injections (such as minimally invasive procedures) within 6 months prior to the start of the trial.
- •Those with a history of hair transplant surgery.
- •Those suffering from other systemic or scalp diseases that may affect hair growth (e.g., iron deficiency anemia, immune disorders, thyroid diseases, and syphilis).
- •Those with a history of severe inflammation, keloids, malignant tumors, or poor wound healing at the treatment site.
- •Those with other diseases that make them unsuitable for fractional laser treatment.
- •Those with a history of malignant tumors or currently undergoing treatment.
- •Participants must not undergo any cosmetic procedures that may affect scalp condition or hair growth throughout the entire trial period, including hair dyeing, perming, bleaching, scalp exfoliation, deep scalp cleansing, or any other actions that may irritate or damage the scalp.
研究组 & 干预措施
A: left scalp: exosome/right scalp: normal saline
During the first 3 months, participants received fractional laser treatment once a month. The left scalp was applied with exosome product once in the morning and once in the evening, while the right scalp was applied with normal saline once in the morning and once in the evening, with each dose being 1 ml. During the next 3 months, the left scalp was applied with the exosome product once in the morning and once in the evening, while the right scalp was applied with normal saline once in the morning and once in the evening.
干预措施: fraction laser (Device)
B: right scalp: exosome/left scalp: normal saline
During the first 3 months, participants received fractional laser treatment once a month. The right scalp was applied with exosome product once in the morning and once in the evening, while the left scalp was applied with normal saline once in the morning and once in the evening, with each dose being 1 ml. During the next 3 months, the right scalp was applied with the exosome product once in the morning and once in the evening, while the left scalp was applied with normal saline once in the morning and once in the evening.
干预措施: fraction laser (Device)
结局指标
主要结局
Change in hair density (d84)
时间窗: Baseline to Day 84
Evaluation of the change in hair density of fractional laser combined with exosomes in improving hair growth
次要结局
- Change in hair density (d168)(Baseline to Day 168)
- Change in Hair diameter (d168)(Baseline to Day 168)
- Change in the percentage of vellus hair and terminal hair (d168)(Baseline to Day 168)
- Change in global photographic assessment (d168)(Baseline to Day 168)