Clinical Evaluation of Localized Scalp Thread Embedding for Male Androgenetic Alopecia

Beijing University of Chinese Medicine, Shenzhen Hospital

Status: Completed

Conditions: Androgenetic Alopecia

Treatments: Procedure: Localized scalp thread embedding

Study type: Interventional

Funder types: Other

Identifiers

NCT06879119

JDF-IRB-2021050102

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Observational cohort: localized scalp thread embedding

Other group

Description:

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.

Treatment:

Procedure: Localized scalp thread embedding