Female Pattern Hair LossPRFNCT06440655
The Efficacy and Safety of Platelet-rich Fibrin and Platelet Rich Plasma in Female Pattern Hair Loss Patients
A study testing Platelet rich plasma and Platelet rich fibrin in people with Female Pattern Hair Loss and Platelet-Rich Plasma, run by Siriraj Hospital at 2 sites in Thailand.
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… Read more about this study
- Who is it for?
- Ages 20 to 55 years, women only
- Conditions the study is for
- Female Pattern Hair Loss, Platelet-Rich Plasma, Platelet-rich Fibrin
- What is being tested?
- Platelet rich plasma and Platelet rich fibrin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesThailand
- Study dates
- 30 May 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites, 2 recruiting
- Recruiting
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok Noi, Bangkok, 10700
Noldtawat Viriyaskultorn, M.D., +66819228736, noldtawat.vir@gmail.com
Rattapon Thuangtong, M.D., +66815533305, rattaponthuangtong@yahoo.com
- Recruiting
Medicine Siriraj Hospital, Mahidol University
Bangkok Noi, Bangkok, 10700
Noldtawat Viriyaskultorn, M.D., 0819228736, noldtawat.vir@gmail.com
Rattapon Thuangtong, M.D., +66815533305, rattaponthuangtong@yahoo.com
About this study
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
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
Read the 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
- Being tested
- Platelet rich plasma, Platelet rich fibrin
- Keywords
- female pattern hair loss, platelet-rich plasma, platelet-rich fibrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich plasmaDevice
Also called PRP
Subjects were treated by Platelet rich plasma in each side of head (Left or right)
Platelet rich fibrinDevice
Also called PRF
Subjects were treated by Platelet rich fibrin in each side of head (Left or right)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: Platelet rich plasma; Device: Platelet rich fibrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trichoscan
Average counts and density of hair per 1.5mm^2
Measured: 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
Evaluation of improvement through picture by doctor
Measured: 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
Evaluation of improvement through picture by patient
Measured: 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
pain during intervention
Measured: baseline(week0), 1 month after first treatment(week4), 1 months after second treatment(week8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start30 May 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Pattern Hair LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All subject were injected with PRP and PRF at baseline, 4 weeks and 8 weeks with split-head of sides of injection.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rattapon Thuangtong, Siriraj Hospital
- Investigators
- Rattapon Thuangtong, Asst. Prof., Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06440655
- Sponsor's protocol ID
- COA no. Si286/2023
- Acronym
- PRF
- Status last verified
- May 2024
- First submitted
- 6 Feb 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Prohibited from laws (and/or rules, regulations, contracts). Fear of inappropriate use of data
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06440655
- Acronym / sponsor ID
- PRF / COA no. Si286/2023
- Keywords
- female pattern hair loss, platelet-rich plasma, platelet-rich fibrin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- 30 May 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subject were injected with PRP and PRF at baseline, 4 weeks and 8 weeks with split-head of sides of injection.
| Arm | Type | Receives |
|---|---|---|
| PRF and PRP | Experimental | Device: Platelet rich plasma, Device: Platelet rich fibrinAll 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) |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet rich plasmaAlso: PRPSubjects were treated by Platelet rich plasma in each side of head (Left or right) | Device | PRF and PRP |
| Platelet rich fibrinAlso: PRFSubjects were treated by Platelet rich fibrin in each side of head (Left or right) | Device | PRF and PRP |
Primary outcome
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
3 secondary outcomes
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)
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)
Visual analog scale
Time frame: baseline(week0), 1 month after first treatment(week4), 1 months after second treatment(week8)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Individual participant dataSharing planned: No. Prohibited from laws (and/or rules, regulations, contracts). Fear of inappropriate use of data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rattapon Thuangtong, Asst. Prof. principal investigator
Mahidol University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet rich plasma and Platelet rich fibrin in people with Female Pattern Hair Loss and Platelet-Rich Plasma, run by Siriraj Hospital at 2 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rattapon Thuangtong, Asst. Prof. (+66815533305, rattaponthuangtong@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trichoscan (time frame: baseline(week0), 4 months after last treatment(week20), 6 months after last treatment(week28)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.