Clinical Evaluation of Localized Scalp Thread Embedding for Male Androgenetic Alopecia

Clinical Efficacy Study of Localized Scalp Thread Embedding in the Treatment of 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.

Study Overview

• Status: Completed
• Conditions: Androgenetic Alopecia
• Intervention / Treatment: Procedure: Localized scalp thread embedding

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Dongfang Hospital Beijing University of Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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.

Procedure: Localized 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hair Shaft Parameters	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.	From enrollment to the end of treatment at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scalp thickness	Scalp thickness measured by B-mode ultrasound（Acuson S1000，Siemens AG，Germany）	From enrollment to the end of treatment at 6 months
Scalp blood flow	Scalp blood flow velocity assessed by Doppler ultrasound （Acuson S1000，Siemens AG，Germany）	From enrollment to the end of treatment at 6 months
Scalp sebum production	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.	From enrollment to the end of treatment at 6 months

Collaborators and Investigators

• Sponsor: Beijing University of Chinese Medicine, Shenzhen Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2021
• Primary Completion (Actual): November 25, 2021
• Study Completion (Actual): November 25, 2021

Study Registration Dates

• First Submitted: March 11, 2025
• First Submitted That Met QC Criteria: March 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 15, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Androgenetic Alopecia; Non-pharmacological interventions; Interventional study
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Skin Diseases; Hypotrichosis; Hair Diseases; Alopecia Areata; Alopecia
• Other Study ID Numbers: JDF-IRB-2021050102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No