Clinical trial NCT06440655: The Efficacy and Safety of Platelet-rich Fibrin and Platelet Rich Plasma in Female Pattern Hair Loss Patients
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Female Pattern Hair Loss
Platelet-Rich Plasma
Platelet-rich Fibrin
Keywords: female pattern hair loss
platelet-rich plasma
platelet-rich fibrin
Lead sponsor: Siriraj Hospital
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 10
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subject were injected with PRP and PRF at baseline, 4 weeks and 8 weeks with split-head of sides of injection.
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Trichoscan
timeFrame: baseline(week0), 4 months after last treatment(week20), 6 months after last treatment(week28)
Secondary outcomes:
measure: The 7-point of doctor subjective global assessment
timeFrame: 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)
measure: The 7-point of patient subjective global assessment
timeFrame: 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)
measure: Visual analog scale
timeFrame: baseline(week0), 1 month after first treatment(week4), 1 months after second treatment(week8)
Other outcomes:
Locations:
city: Bangkok Noi
country: Thailand
facility: Faculty of Medicine Siriraj Hospital, Mahidol University
state: Bangkok
city: Bangkok Noi
country: Thailand
facility: Medicine Siriraj Hospital, Mahidol University
state: Bangkok
Study officials:
affiliation: Mahidol University
name: Rattapon Thuangtong, Asst. Prof.
role: PRINCIPAL_INVESTIGATOR
References: