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

Platelet-Rich Plasma Clinical Trial

— PRF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06440655
• Other study ID #: COA no. Si286/2023
• Status: Recruiting
• Phase: N/A
• Start date: May 30, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: May 2024
• Source: Siriraj Hospital
• Contact: Rattapon Thuangtong, Asst. Prof.
• Phone: +66815533305
• Email: rattaponthuangtong[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: September 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Female Pattern Hair Loss
• Platelet-rich Fibrin
• Platelet-Rich Plasma

Intervention

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

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkok Noi	Bangkok
Thailand	Medicine Siriraj Hospital, Mahidol University	Bangkok Noi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Siriraj Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The 7-point of doctor subjective global assessment	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)
Secondary	The 7-point of patient subjective global assessment	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)
Secondary	Visual analog scale	pain during intervention	baseline(week0), 1 month after first treatment(week4), 1 months after second treatment(week8)