Clinical Efficacy Study of Localized Scalp Thread Embedding in the Treatment of Male Androgenetic Alopecia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Hair Shaft Parameters
研究概览
简要总结
This clinical study aims to evaluate a breakthrough treatment for hair loss (androgenetic alopecia, AGA) using dissolvable threads placed under the scalp skin. The investigators hypothesize that these specially designed threads can improve hair growth, avoiding the need for invasive surgery.
Current AGA treatments taken orally often have limitations, prompting researchers to explore localized approaches. While early studies show promise for localized scalp thread embedding, three key challenges remain: 1) No standardized way to measure effectiveness, 2) Lack of objective biological markers to track progress, and 3) Limited understanding of how exactly these treatments work.
This study addresses these gaps through precise thread placement in balding areas, following international dermatology guidelines. Using advanced measurement tools, the investigators will track changes in hair thickness (primary measure), blood flow patterns under the skin, and oil gland activity (secondary measures). By focusing on one key treatment factor, this research provides the first comprehensive evidence showing how this minimally invasive approach may slow or reverse AGA progression.
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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 18-50 years
- •No clinically significant comorbidities
- •Androgenetic alopecia (Hamilton-Norwood III-V)
- •No systemic anti-hair loss therapy use within 3 months
- •No topical hair regrowth agent use within 3 months
排除标准
- •Active scalp infection
- •Scalp psoriasis
- •Scalp eczema
- •Open scalp wounds
- •Allergy to thread materials
- •Uncontrolled diabetes mellitus
- •Immunodeficiency disorders
- •Non-compliance with follow-up visits
- •Refusal to provide informed consent
- •Investigator-deemed contraindications
研究组 & 干预措施
Observational cohort: localized scalp thread embedding
All participants meeting the inclusion criteria underwent a standardized scalp thread embedding procedure targeting the vertex alopecic area. Participants were prospectively observed for 6 months, with monthly follow-up assessments to evaluate outcomes . No additional interventions were administered during follow-up.
干预措施: Localized scalp thread embedding (Procedure)
结局指标
主要结局
Hair Shaft Parameters
时间窗: From enrollment to the end of treatment at 6 months
The German FotoFinder trichoscopy system (FotoFinder Systems GmbH, Birbach, Germany) was utilized, incorporating its integrated trichometric analysis module and high-resolution optical imaging system (Medicam 1000HD) with 20X-140X magnification. Hair shaft parameters include: total hair count, hair density, hair shaft diameter, and hair follicle typing.
次要结局
- Scalp thickness(From enrollment to the end of treatment at 6 months)
- Scalp blood flow(From enrollment to the end of treatment at 6 months)
- Scalp sebum production(From enrollment to the end of treatment at 6 months)
研究者
Aijuan Wang
Attending Physician, M.D.
Beijing University of Chinese Medicine, Shenzhen Hospital