Effectiveness of Apheresis Platelet-Rich Plasma Injection for Androgenic Alopecia

NCT07348315 | Completed Phase 2

• 1 other identifier: 2023xjsxxm-28
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

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.

Conditions

Androgenic Alopecia

Keywords

Androgenetic Alopecia; Platelet-Rich Plasma

Outcome Measures

Primary Outcomes (1)

• Response Based on the Basic and Specific (BASP) classification

  The proportion of participants achieving a positive response, defined as an improvement of at least one grade in either the Basic or Specific component of the BASP system, as assessed by blinded, independent physicians on standardized photographs after PRP treatment compared to baseline. As the protocol allows for 3 to 5 injection sessions at intervals of 3 to 5 weeks, the 'End of Treatment' visit occurs on a variable calendar date, falling between Week 9 and Week 25 after the first injection. This design ensures that the assessment captures the cumulative effect of the complete, individualized treatment course for each participant.

  Baseline (pre-first injection) and End of treatment (pre-final injection, ranging from Week 9 to Week 25)

Secondary Outcomes (2)

• Patient-Reported Improvement Questionnaire

  At 1 month after treatment completion

• Incidence of treatment-related adverse events.

  From first treatment to 1 month after last treatment, up to 6 months

Study Arms (1)

Autologous Apheresis PRP Injection

EXPERIMENTAL

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.

Biological: Autologous Apheresis PRP Injection

Interventions

Autologous Apheresis PRP Injection 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.

Autologous Apheresis PRP Injection

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• Hemoglobin concentration \> 120 g/L
• Hematocrit 0.30 to 0.50
• Platelet count \> 110 × 10\^9/L
• No clinically significant abnormalities in inflammation, coagulation, or electrolyte panels

You may not qualify if:

• 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

Sponsors & Collaborators

• zhang li: lead

Study Sites (1)

The General Hospital of Western Theater Command

Chengdu, Sichuan, 610036, 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: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: To ensure objective assessment, all photographs were anonymized by removing any time or sequence identifiers. Subsequently, these photographs were randomly assigned to 2 or 3 independent, blinded physicians for the assessment of hair loss severity. The physicians were blinded to the treatment stage (before- or after-treatment), patient identity, and PRP cellular composition throughout the grading process.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 16, 2026
• Study Start: September 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: December 12, 2025
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)