NCT05348343

Activated PRP for Treatment of Androgenetic Alopecia

A Pilot Clinical 'Proof of Concept' Study of Activated Platelet-rich Plasma (PRP) in Subjects With Androgenetic Alopecia (AGA)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Santiste Medical Inc. · Industry
• Sex: Male
• Age: 30 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

A clinical trial to assess the effects and safety of PRP activated with pulsed electrical fields (PEFA-PRP) compared with unactivated PRP when used to treat AGA. The design of this small-scale, phase 1b/2a clinical trial is to demonstrate that pulsed electric field activation of autologous PRP results in a controlled release of platelet growth factors and other biologically active molecules that will have a benefit effect on the non-cycling hair follicles in the treated scalp compared to non-activated PRP. This single-center, auto-controlled study will compare the clinical benefit of PEFA-PRP versus non-activated PRP treatment of male patients with AGA.

Conditions

• Androgenetic Alopecia

Interventions

Type	Name	Description
BIOLOGICAL	Autologous platelet-rich plasma	PRP created using a commercially available system will be used for treatment. PEFA-PRP will be created by subjecting PRP to a pulsed electrical field in a specially designed instrument developed by sponsor. Two 9 cm2 contralateral regions of interest (ROI) on the scalp will be treated with approximately 6mL of either PRP or PEFA-PRP by subcutaneous injection.

Timeline

• Start date: 2022-05-17
• Primary completion: 2023-09-01
• Completion: 2023-09-01
• First posted: 2022-04-27
• Last updated: 2025-04-27

Locations

1 site across 1 country: United States