Comparing Platelet-Rich Plasma (PRP) Centrifugation Methods on Thrombocyte Concentration and Clinical Improvement of Androgenetic Alopecia

January 3, 2023 updated by: Dr. dr. Lili Legiawati, SpKK(K), Indonesia University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
        • Recruiting
        • Cipto mangunkusumo general hospital
        • Contact:
        • Principal Investigator:
          • Lis Surachmiati Suseno, MD
        • Principal Investigator:
          • Irma Bernadette, MD, PhD
        • Principal Investigator:
          • Shannaz N Yusharyahya, MD, PhD
    • Jakarta
      • Jakarta Pusat, Jakarta, Indonesia, 10430
        • Enrolling by invitation
        • Universitas Indonesia

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Single Spin Group
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%)
Procedure: Platelet-Rich Plasma Injections (PRP) on the Scalp
each subject will be treated with 3x PRP injections on the scalp with 2 weeks interval in addition to daily minoxidil administration.
Other Names:
  • Regrou Forte (5% Minoxidil solution)
Active Comparator: Double Spin Group
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%)
Procedure: Platelet-Rich Plasma Injections (PRP) on the Scalp
each subject will be treated with 3x PRP injections on the scalp with 2 weeks interval in addition to daily minoxidil administration.
Other Names:
  • Regrou Forte (5% Minoxidil solution)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
6 weeks
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.
6 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Indonesia 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 (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 20, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 876/UN2.F1/ETIK/PPM.00.02/2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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