The Efficacy and Safety of Platelet-rich Fibrin and Platelet Rich Plasma in Female Pattern Hair Loss Patients

Not Applicable

Recruiting

• Conditions: Female Pattern Hair Loss; Platelet-rich Fibrin; Platelet-Rich Plasma
• Interventions: Device: Platelet rich plasma; Device: Platelet rich fibrin

• Registration Number: NCT06440655
• Lead Sponsor: Siriraj Hospital

Brief Summary

The goal of this clinical trial is to compare between platelet-rich fibrin and platelet-rich plasma in female pattern hair loss . The main question\[s\] it aims to answer are:

* efficacy between platelet-rich fibrin and platelet-rich plasma

* safety between platelet-rich fibrin and platelet-rich plasma Participants will be divided into 2 side of treatment with composed of

1. Platelet rich plasma

2. Platelet rich fibrin

Detailed Description

Subject was treated both platelet-rich fibrin and platelet-rich plasma for 3 times which 1 month interval then will be followed up at 4 months and 6 months after last treatment

Study Timeline

• Study Start: 2023-05-30
• Study First Submitted: 2024-02-06
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-27
• Last Update Submitted: 2024-05-27
• Study First Posted: 2024-06-04
• Last Update Posted: 2024-06-04
• Primary Completion: 2024-06-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

• Age 20-55 years
• Female
• Subject who was diagnosed with Female pattern hair loss in Ludwig Classification 2 (part width 2-4 centimeters) by Dermatologist

Exclusion Criteria

• Pregnancy or Lactation subjects
• Subject with history of platelet dysfunction, low platelet, anemia, cirrhosis, cancer, or immunocompromised host
• Subject who are active smoking and alcoholism
• Subject who has dermatitis, scar or infection at intervention area
• Subject who has history of allergy to anesthesia drug
• Subject who taking NSAIDs, Hormonal drug, anticoagulants drug
• Subject who has psychiatric condition diagnosed by psychiatrist
• Subject who are not allowed to take a photo

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PRF and PRP	Platelet rich plasma	All patients were treated with both platelet rich fibrin and platelet rich plasma but each side of head (left or right) was split with * one side of head was injected with platelet rich plasma at week 0,4 and 8 (total 3 times) * another side of head was injected with platelet rich fibrin at week 0,4 and 8 (total 3 times)
PRF and PRP	Platelet rich fibrin	All patients were treated with both platelet rich fibrin and platelet rich plasma but each side of head (left or right) was split with * one side of head was injected with platelet rich plasma at week 0,4 and 8 (total 3 times) * another side of head was injected with platelet rich fibrin at week 0,4 and 8 (total 3 times)

Primary Outcome Measures

Name	Time	Method
Trichoscan	baseline(week0), 4 months after last treatment(week20), 6 months after last treatment(week28)	Average counts and density of hair per 1.5mm\^2

Secondary Outcome Measures

Name	Time	Method
Visual analog scale	baseline(week0), 1 month after first treatment(week4), 1 months after second treatment(week8)	pain during intervention
The 7-point of doctor subjective global assessment	baseline(week0),1 month after first treatment(week4), 1 months after second treatment(week8), 4 months after last treatment(week20), 6 months after last treatment(week28)	Evaluation of improvement through picture by doctor
The 7-point of patient subjective global assessment	baseline(week0),1 month after first treatment(week4), 1 months after second treatment(week8), 4 months after last treatment(week20), 6 months after last treatment(week28)	Evaluation of improvement through picture by patient

Trial Locations

Locations (2)

Medicine Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok Noi, Bangkok, Thailand

Faculty of Medicine Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok Noi, Bangkok, Thailand