Effectiveness of Apheresis Platelet-Rich Plasma Injection for Androgenic Alopecia

NCT ID: NCT07348315

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 201 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2025-12-12

Brief Summary

This study was retrospectively registered. The goal of this single-arm, single-center, prospective clinical trial is to evaluate the effectiveness and safety of autologous apheresis platelet-rich plasma (PRP) injection in the treatment of androgenetic alopecia (AGA). The main questions it aims to answer are:

• Is apheresis PRP effective in improving hair growth outcomes in male patients with AGA?
• Is treatment response associated with key variables, including patient age, number of treatment sessions, baseline severity, and PRP cellular composition?
• Does PRP injection lead to any serious adverse events in the treatment of AGA? Researchers will record the effectiveness and adverse events following autologous apheresis PRP treatment for AGA and perform statistical analyses to evaluate treatment outcomes and their correlates with the variables of interest.

Participants will:

• Receive 3 to 5 sessions of autologous apheresis PRP injections into the scalp at intervals of 3-5 weeks.
• Have standardized photographs of the scalp taken from four angles (frontal, vertex, and bilateral sides) prior to each PRP injection.
• Attend a follow-up clinic visit or complete a telephone assessment one month after the final PRP injection.

Detailed Description

Androgenetic alopecia (AGA) is a progressive condition with limited optimal therapeutic options. While platelet-rich plasma (PRP) therapy has been explored, the apheresis technique offers a distinct method of PRP preparation that yields higher platelet purity and more consistent cellular composition compared to conventional centrifugation methods. This study is specifically designed to evaluate the clinical effectiveness of this autologous apheresis PRP and identify key predictors. Given the exploratory nature of this investigation aimed at generating preliminary efficacy and safety data for a specific PRP preparation method, a single-arm design was chosen.

The apheresis procedure was performed using a closed-system blood cell separator according to the manufacturer's standardized protocol. All injections were uniformly administered following a strict procedural guideline.

The primary endpoint, change in the BASP classification, was assessed by independent, blinded physicians. The associations between treatment response and key variables, including age, number of sessions, baseline severity, and PRP cellular composition were explored through correlation and regression models.

Conditions

Androgenic Alopecia

Study Design

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

Study Groups

Autologous Apheresis PRP Injection

All enrolled participants will receive autologous apheresis platelet-rich plasma (PRP) injections into the scalp according to the defined protocol. This is the only arm in this single-arm trial.

Group Type: EXPERIMENTAL

Autologous Apheresis PRP Injection

Intervention Type: BIOLOGICAL

Autologous PRP was prepared using a closed-system blood cell separator with disposable blood cell collection consumables, following the manufacturer's standardized protocol.

Using a 30-gauge sterile needle, PRP was administered via intradermal and subcutaneous injections at multiple points across the treatment area, with an injection volume of 0.05 mL per point at intervals of approximately 0.5 cm.

Participants received 3 to 5 sessions of autologous apheresis PRP injections into the scalp at intervals of 3-5 weeks.

Interventions

Autologous Apheresis PRP Injection

Autologous PRP was prepared using a closed-system blood cell separator with disposable blood cell collection consumables, following the manufacturer's standardized protocol.

Using a 30-gauge sterile needle, PRP was administered via intradermal and subcutaneous injections at multiple points across the treatment area, with an injection volume of 0.05 mL per point at intervals of approximately 0.5 cm.

Participants received 3 to 5 sessions of autologous apheresis PRP injections into the scalp at intervals of 3-5 weeks.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• History of hair loss for more than 6 months
• Diagnosed with androgenetic alopecia (AGA) based on the Chinese guideline for diagnosis and treatment of AGA
• In good general health with a body weight ≥ 50 kg
• No history of hypertension, diabetes, platelet dysfunction, or any other contraindication to PRP apheresis
• No use of finasteride, minoxidil, or any other treatment for hair loss within the 6 months preceding enrollment
• No recent use of glucocorticoids (topical to treatment site for 1 month; systemic for 2 weeks) prior to PRP apheresis
• No recent use of nonsteroidal anti-inflammatory drugs (within 48 hours) prior to PRP apheresis
• Blood tests within 2 weeks before PRP apheresis meeting the following criteria:

1. Hemoglobin concentration > 120 g/L

2. Hematocrit 0.30 to 0.50

3. Platelet count > 110 × 10^9/L

4. No clinically significant abnormalities in inflammation, coagulation, or electrolyte panels

Exclusion Criteria

• Concurrent use of finasteride, minoxidil, or other hair growth treatments during the PRP treatment phase of the study
• Failure to complete a minimum of 3 consecutive PRP treatment sessions as per the study protocol
• Failure to complete the required follow-up assessments for any reason

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

zhang li

OTHER

Sponsor Role: lead

Responsible Party

zhang li

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

The General Hospital of Western Theater Command

Chengdu, Sichuan, China

Countries

China

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2023xjsxxm-28

Identifier Type: -

Identifier Source: org_study_id