Androgenetic Alopecia
Conditions
Keywords
Androgenetic Alopecia, Interventional study, Non-pharmacological interventions
Brief summary
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.
Interventions
PROCEDURELocalized scalp thread embedding
Volunteers who met the inclusion criteria were enrolled in the trial. All participants underwent treatment intervention in the vertex alopecic area via vertex alopecic area scalp thread embedding. A single thread embedding session was performed upon enrollment, with monthly follow-ups conducted over a total period of 6 months. Operative procedure: After fully exposing and disinfecting the treatment area, threads were inserted into the scalp at an approximately 15-degree oblique angle, with needle tips reaching the subgaleal space at a depth of 2-4 mm. Threads were spaced 1 cm apart. Upon completion, the treated area was disinfected and applied with erythromycin ointment.
Sponsors
Beijing University of Chinese Medicine, Shenzhen Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Male sex * 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hair Shaft Parameters | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Scalp thickness | From enrollment to the end of treatment at 6 months | Scalp thickness measured by B-mode ultrasound（Acuson S1000，Siemens AG，Germany） |
| Scalp blood flow | From enrollment to the end of treatment at 6 months | Scalp blood flow velocity assessed by Doppler ultrasound （Acuson S1000，Siemens AG，Germany） |
| Scalp sebum production | From enrollment to the end of treatment at 6 months | The scalp sebum measurement was performed using the German Sebumeter SM815 (Courage & Khazaka electronic GmbH, Germany), with sebum test kits procured from Beijing Jinhongfan Trading Co., Ltd. The quantification principle adheres to the internationally recognized SEBUMETER® methodology, which employs photometric analysis to quantify sebum content by measuring light transmittance through a 0.1-mm-thick matte-finish adhesive film that absorbs cutaneous lipids. |
Countries
China
Outcome results
None listed