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

NCT06440655 | Recruiting

• 1 other identifier: COA no. Si286/2023
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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
• Platelet rich plasma
• Platelet rich fibrin

Conditions

Female Pattern Hair Loss; Platelet-Rich Plasma; Platelet-rich Fibrin

Keywords

female pattern hair loss; platelet-rich plasma; platelet-rich fibrin

Outcome Measures

Primary Outcomes (1)

• Trichoscan

  Average counts and density of hair per 1.5mm\^2

  baseline(week0), 4 months after last treatment(week20), 6 months after last treatment(week28)

Secondary Outcomes (3)

• 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)

• 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)

• Visual analog scale

  baseline(week0), 1 month after first treatment(week4), 1 months after second treatment(week8)

Study Arms (1)

PRF and PRP

EXPERIMENTAL

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)

Device: Platelet rich plasma; Device: Platelet rich fibrin

Interventions

Platelet rich plasma DEVICE

Subjects were treated by Platelet rich plasma in each side of head (Left or right)

Also known as: PRP

PRF and PRP

Platelet rich fibrin DEVICE

Subjects were treated by Platelet rich fibrin in each side of head (Left or right)

Also known as: PRF

PRF and PRP

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Siriraj Hospital: lead

Study Sites (2)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok Noi, Bangkok, 10700, Thailand

RECRUITING

Medicine Siriraj Hospital, Mahidol University

Bangkok Noi, Bangkok, 10700, Thailand

RECRUITING

Study Officials

• Rattapon Thuangtong, Asst. Prof.

  Mahidol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rattapon Thuangtong, Asst. Prof.

CONTACT

+66815533305; rattaponthuangtong@yahoo.com

Noldtawat Viriyaskultorn, MD

CONTACT

+66819228736; noldtawat.vir@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: All subject were injected with PRP and PRF at baseline, 4 weeks and 8 weeks with split-head of sides of injection.

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: June 4, 2024
• Study Start: May 30, 2023
• Primary Completion: June 30, 2024
• Study Completion: September 30, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TH (2)