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NCT Number: NCT06879119

Clinical Evaluation of Localized Scalp Thread Embedding for Male Androgenetic Alopecia

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.

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Key information

Conditions

Androgenetic Alopecia Alopecia Hair Diseases Hypotrichosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Dongfang Hospital Beijing University of Chinese Medicine

Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Localized scalp thread embedding

Procedure

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.

Primary outcomes

  1. Hair Shaft Parameters

    Time frame: 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 outcomes

  1. Scalp thickness

    Time frame: From enrollment to the end of treatment at 6 months

    Scalp thickness measured by B-mode ultrasound（Acuson S1000，Siemens AG，Germany）

  2. Scalp blood flow

    Time frame: From enrollment to the end of treatment at 6 months

    Scalp blood flow velocity assessed by Doppler ultrasound （Acuson S1000，Siemens AG，Germany）

  3. Scalp sebum production

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Beijing University of Chinese Medicine, Shenzhen Hospital

Other

Registry information

Official study title

Clinical Efficacy Study of Localized Scalp Thread Embedding in the Treatment of Male Androgenetic Alopecia

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 17, 2025
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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