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

May 27, 2024 updated by: Rattapon Thuangtong, Siriraj Hospital

A Randomized, Split-head Comparison Study of the Efficacy and Safety of Platelet-rich Fibrin and Platelet Rich Plasma in Female Pattern Hair Loss Patients : A Pilot Study

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Thailand
    • Bangkok
      • Bangkok Noi, Bangkok, Thailand, 10700
        • Recruiting
        • Faculty of Medicine Siriraj Hospital, Mahidol University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rattapon Thuangtong, M.D.
      • Bangkok Noi, Bangkok, Thailand, 10700
        • Recruiting
        • Medicine Siriraj Hospital, Mahidol University
        • Contact:
        • Principal Investigator:
          • Rattapon Thuangtong, M.D.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PRF and PRP

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
Subjects were treated by Platelet rich plasma in each side of head (Left or right)
Other Names:
  • PRP
Device: Platelet rich fibrin
Subjects were treated by Platelet rich fibrin in each side of head (Left or right)
Other Names:
  • PRF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trichoscan
Time Frame: baseline(week0), 4 months after last treatment(week20), 6 months after last treatment(week28)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The 7-point of doctor subjective global assessment
Time Frame: 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
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
Time Frame: 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
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
Time Frame: baseline(week0), 1 month after first treatment(week4), 1 months after second treatment(week8)
pain during intervention
baseline(week0), 1 month after first treatment(week4), 1 months after second treatment(week8)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Siriraj Hospital

Investigators

  • Principal Investigator: Rattapon Thuangtong, Asst. Prof., Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2023

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

February 6, 2024

First Submitted That Met QC Criteria

May 27, 2024

First Posted (Estimated)

June 4, 2024

Study Record Updates

Last Update Posted (Estimated)

June 4, 2024

Last Update Submitted That Met QC Criteria

May 27, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COA no. Si286/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Prohibited from laws (and/or rules, regulations, contracts). Fear of inappropriate use of data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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