Clinical Evaluation of Localized Scalp Thread Embedding for Male Androgenetic Alopecia

NCT06879119 | Completed DMC

• 1 other identifier: JDF-IRB-2021050102
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Androgenetic Alopecia

Keywords

Androgenetic Alopecia; Interventional study; Non-pharmacological interventions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (1)

Observational cohort: localized scalp thread embedding

OTHER

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

Interventions

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.

Observational cohort: localized scalp thread embedding

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing University of Chinese Medicine, Shenzhen Hospital: lead

Study Sites (1)

Dongfang Hospital Beijing University of Chinese Medicine

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician, M.D.

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 17, 2025
• Study Start: May 27, 2021
• Primary Completion: November 25, 2021
• Study Completion: November 25, 2021
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)