Alopecia, AndrogeneticNCT05681897
Comparing Platelet-Rich Plasma (PRP) Centrifugation Methods on Thrombocyte Concentration and Clinical Improvement of Androgenetic Alopecia
A study testing Platelet-Rich Plasma Injections (PRP) on the Scalp in people with Alopecia, Androgenetic, run by Universitas Indonesia at 2 sites in Indonesia.
Trial summary
This research is a preliminary, randomized, double blind clinical trial, which will examine the differences in PRP preparation methods, a single-spin centrifugation of 3000 rpm in 15 minutes compared to a double-spin centrifugation of 1500 rpm in 6 minutes followed by 2500 rpm in 15 minutes, on the results of… Read more about this study
- Who is it for?
- Ages 25 to 59 years, men only
- Conditions the study is for
- Alopecia, Androgenetic
- What is being tested?
- Platelet-Rich Plasma Injections (PRP) on the Scalp
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesIndonesia
- Study dates
- Feb 2023to Feb 2023
- 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 25 to 59 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Met the criteria of androgenic alopecia (Hamilton Norwood grade III-IV)
- Men between ages 25-59 years old
- Have stopped taking topical anti-androgen or minoxidil for at least one month, or oral anti-androgen or minoxidil for at least three months
Who cannot join
- alopecia of any other type
- subject with a history of keloid or blood coagulation disorders underwent anticoagulant therapy
- subjects on Non-Steroidal Anti-Inflammatory Drugs (NSAID) medications in seven days prior to the study
- subjects who had hair treatment using growth factors, including PRP and microneedling within at least six months prior to the study.
Trial locations and contacts
2 sites in 1 country.
Indonesia2 sites, 2 recruiting
- Recruiting
Cipto Mangunkusumo General Hospital
Jakarta Pusat, DKI Jakarta, 10430
Lili Legiawati, MD, PhD, +62816707990, lililegiawati@yahoo.com
Lis Surachmiati Suseno, MD
- Enrolling by invitation
Universitas Indonesia
Jakarta Pusat, Jakarta Special Capital Region, 10430
About this study
Official title: Comparing Platelet-Rich Plasma (PRP) Centrifugation Methods on Thrombocyte Concentration and Clinical Improvement of Androgenetic Alopecia: A Preliminary, Randomized, Double-Blind Clinical Trial
This research is a preliminary, randomized, double blind clinical trial, which will examine the differences in PRP preparation methods, a single-spin centrifugation of 3000 rpm in 15 minutes compared to a double-spin centrifugation of 1500 rpm in 6 minutes followed by 2500 rpm in 15 minutes, on the results of Thrombocyte Concentration and Clinical Improvement of Androgenetic Alopecia.
Read the detailed description
Several examinations will be performed in every visit, including history taking, physical examination, trichoscopy and trichoscan. Laboratory evaluations (complete blood count) for the measurement of the thrombocyte for baseline and PRP will be performed for all assented subjects on the first visit. Each subject will be instructed to apply 5% topical minoxidil twice a day everyday as primary therapy during the study
- Conditions
- Alopecia, Androgenetic
- Being tested
- Platelet-Rich Plasma Injections (PRP) on the Scalp
- Keywords
- Androgenetic Alopecia, Centrifugation, Platelet-rich plasma, Thrombocyte
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-Rich Plasma Injections (PRP) on the ScalpProcedure or surgery
Also called Regrou Forte (5% Minoxidil solution)
each subject will be treated with 3x PRP injections on the scalp with 2 weeks interval in addition to daily minoxidil administration.
| Study group | Role | What they receive |
|---|---|---|
| Single Spin Group | Other | Currently, the standard operating procedures for PRP preparation in dr. Cipto Mangunkusumo National General Hospital is by performing a single-spin centrifugation at 3000 rpm for 15 minutes. This first group will received PRP treatment by single-spin centrifugation at 3000 rpm in 15 minutes in addition to topical minoxidil (5%) Receives: Procedure: Platelet-Rich Plasma Injections (PRP) on the Scalp |
| Double Spin Group | Active comparator | This group will received double-spin centrifugation PRP treatment at 1500 rpm in 6 minutes and continued at 2500 rpm in 15 minutes in addition to topical minoxidil (5%) Receives: Procedure: Platelet-Rich Plasma Injections (PRP) on the Scalp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombocyte Count in PRP and Whole Blood
We assessed the increase in PRP platelet levels by assessing baseline platelets (using whole blood) and assessing platelet levels in PRP preparations and then calculating multiples. platelet valuie units to be used is (/μL)
Measured: 6 weeks
Clinical Improvement of Androgenetic Alopecia
We assessed the assessment of clinical improvement in androgenetic alopecia using trichoscopy and trichoscan examination on week 0, 2, 4, and 6. On trichoscopic examination we assessed hair color, hair diameter diversity, vellus hair, and dots. Whereas on trichoscan examination we assessed hair count, hair diameter (mm), hair density (/cm2), hair rate (%) in vellus hair, terminal, anagen and telogen phases and assessed hair mean thickness (mm/cm2) and mean length (mm) and average hair per unit.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study startFeb 2023 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alopecia, AndrogeneticStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. dr. Lili Legiawati, SpKK(K), Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681897
- Sponsor's protocol ID
- 876/UN2.F1/ETIK/PPM.00.02/2
- Status last verified
- Jan 2023
- First submitted
- 20 Dec 2022
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Legiawati L, Yusharyahya SN, Bernadette I, Novianto E, Priyanto MH, Gliselda KC, Iriyanty S, Mutiara R. Comparing Single-spin Versus Double-spin Platelet-rich Plasma (PRP) Centrifugation Methods on Thrombocyte Count and Clinical Improvement of Androgenetic Alopecia: A Preliminary, Randomized, Double-blind Clinical Trial. J Clin Aesthet Dermatol. 2023 Dec;16(12):39-44.
PubMed 38125672
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Platelet-Rich Plasma (PRP) Centrifugation Methods on Thrombocyte Concentration and Clinical Improvement of Androgenetic Alopecia: A Preliminary, Randomized, Double-Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT05681897
- Acronym / sponsor ID
- 876/UN2.F1/ETIK/PPM.00.02/2
- Conditions
- Alopecia, Androgenetic
- Keywords
- Androgenetic Alopecia, Centrifugation, Platelet-rich plasma, Thrombocyte
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 12 Jan 2023 (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.
This research is a preliminary, randomized, double blind clinical trial, which will examine the differences in PRP preparation methods, a single-spin centrifugation of 3000 rpm in 15 minutes compared to a double-spin centrifugation of 1500 rpm in 6 minutes followed by 2500 rpm in 15 minutes, on the results of Thrombocyte Concentration and Clinical Improvement of Androgenetic Alopecia.
Detailed description
Several examinations will be performed in every visit, including history taking, physical examination, trichoscopy and trichoscan. Laboratory evaluations (complete blood count) for the measurement of the thrombocyte for baseline and PRP will be performed for all assented subjects on the first visit. Each subject will be instructed to apply 5% topical minoxidil twice a day everyday as primary therapy during the study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Spin Group | Other | Procedure: Platelet-Rich Plasma Injections (PRP) on the ScalpCurrently, the standard operating procedures for PRP preparation in dr. Cipto Mangunkusumo National General Hospital is by performing a single-spin centrifugation at 3000 rpm for 15 minutes. This first group will received PRP treatment by single-spin centrifugation at 3000 rpm in 15 minutes in addition to topical minoxidil (5%) |
| Double Spin Group | Active comparator | Procedure: Platelet-Rich Plasma Injections (PRP) on the ScalpThis group will received double-spin centrifugation PRP treatment at 1500 rpm in 6 minutes and continued at 2500 rpm in 15 minutes in addition to topical minoxidil (5%) |
Who may qualify
- Ages
- 25 to 59 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Met the criteria of androgenic alopecia (Hamilton Norwood grade III-IV)
- Men between ages 25-59 years old
- Have stopped taking topical anti-androgen or minoxidil for at least one month, or oral anti-androgen or minoxidil for at least three months
Key exclusion criteria (4 listed)
- alopecia of any other type
- subject with a history of keloid or blood coagulation disorders underwent anticoagulant therapy
- subjects on Non-Steroidal Anti-Inflammatory Drugs (NSAID) medications in seven days prior to the study
- subjects who had hair treatment using growth factors, including PRP and microneedling within at least six months prior to the study.
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 Plasma Injections (PRP) on the ScalpAlso: Regrou Forte (5% Minoxidil solution)each subject will be treated with 3x PRP injections on the scalp with 2 weeks interval in addition to daily minoxidil administration. | Procedure or surgery | Double Spin Group, Single Spin Group |
Primary outcome
Thrombocyte Count in PRP and Whole Blood
Time frame: 6 weeks
We assessed the increase in PRP platelet levels by assessing baseline platelets (using whole blood) and assessing platelet levels in PRP preparations and then calculating multiples. platelet valuie units to be used is (/μL)
Clinical Improvement of Androgenetic Alopecia
Time frame: 6 weeks
We assessed the assessment of clinical improvement in androgenetic alopecia using trichoscopy and trichoscan examination on week 0, 2, 4, and 6. On trichoscopic examination we assessed hair color, hair diameter diversity, vellus hair, and dots. Whereas on trichoscan examination we assessed hair count, hair diameter (mm), hair density (/cm2), hair rate (%) in vellus hair, terminal, anagen and telogen phases and assessed hair mean thickness (mm/cm2) and mean length (mm) and average hair per unit.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- Derived from this study: PubMed 38125672Legiawati L, Yusharyahya SN, Bernadette I, Novianto E, Priyanto MH, Gliselda KC, Iriyanty S, Mutiara R. Comparing Single-spin Versus Double-spin Platelet-rich Plasma (PRP) Centrifugation Methods on Thrombocyte Count and Clinical Improvement of Androgenetic Alopecia: A Preliminary, Randomized, Double-blind Clinical Trial. J Clin Aesthet Dermatol. 2023 Dec;16(12):39-44.
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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.
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 Injections (PRP) on the Scalp in people with Alopecia, Androgenetic, run by Universitas Indonesia at 2 sites in Indonesia.
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 4 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 12 Jan 2023. 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 Indonesia. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thrombocyte Count in PRP and Whole Blood (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05681897, which also lists 1 linked publication.
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 12 Jan 2023.