NCT07348315

Effectiveness of Apheresis Platelet-Rich Plasma Injection for Androgenic Alopecia

Effectiveness of Apheresis Platelet-Rich Plasma Injection for Androgenic Alopecia: A Single-Arm Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: zhang li · Academic / Other
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	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.

Timeline

• Start date: 2023-09-01
• Primary completion: 2025-09-01
• Completion: 2025-12-12
• First posted: 2026-01-16
• Last updated: 2026-01-20

Locations

1 site across 1 country: China