Clinical Evaluation of Localized Scalp Thread Embedding for Male Androgenetic Alopecia

NCT ID: NCT06879119

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-27
• Study Completion Date: 2021-11-25

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Localized scalp thread embedding

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Beijing University of Chinese Medicine, Shenzhen Hospital

OTHER

Sponsor Role: lead

Responsible Party

Aijuan Wang

Attending Physician, M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dongfang Hospital Beijing University of Chinese Medicine

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

JDF-IRB-2021050102

Identifier Type: -

Identifier Source: org_study_id