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

Primary Purpose

Alopecia, Androgenetic

Status
Recruiting
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Platelet-Rich Plasma Injections (PRP) on the Scalp
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia, Androgenetic focused on measuring Androgenetic Alopecia, Centrifugation, Platelet-rich plasma, Thrombocyte

Eligibility Criteria

25 Years - 59 Years (Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Cipto Mangunkusumo General HospitalRecruiting
  • Universitas Indonesia

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Single Spin Group

Double Spin Group

Arm Description

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%)

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%)

Outcomes

Primary Outcome Measures

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)
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.

Secondary Outcome Measures

Full Information

First Posted
December 20, 2022
Last Updated
January 3, 2023
Sponsor
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT05681897
Brief Title
Comparing Platelet-Rich Plasma (PRP) Centrifugation Methods on Thrombocyte Concentration and Clinical Improvement of Androgenetic Alopecia
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2023 (Anticipated)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
February 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia, Androgenetic
Keywords
Androgenetic Alopecia, Centrifugation, Platelet-rich plasma, Thrombocyte

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
this is a double-blind masking study
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Spin Group
Arm Type
Other
Arm Description
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%)
Arm Title
Double Spin Group
Arm Type
Active Comparator
Arm Description
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%)
Intervention Type
Procedure
Intervention Name(s)
Platelet-Rich Plasma Injections (PRP) on the Scalp
Other Intervention Name(s)
Regrou Forte (5% Minoxidil solution)
Intervention Description
each subject will be treated with 3x PRP injections on the scalp with 2 weeks interval in addition to daily minoxidil administration.
Primary Outcome Measure Information:
Title
Thrombocyte Count in PRP and Whole Blood
Description
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)
Time Frame
6 weeks
Title
Clinical Improvement of Androgenetic Alopecia
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Cipto Mangunkusumo General Hospital
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lili Legiawati, MD, PhD
Phone
+62816707990
Email
lililegiawati@yahoo.com
First Name & Middle Initial & Last Name & Degree
Lis Surachmiati Suseno, MD
First Name & Middle Initial & Last Name & Degree
Irma Bernadette, MD, PhD
First Name & Middle Initial & Last Name & Degree
Shannaz N Yusharyahya, MD, PhD
Facility Name
Universitas Indonesia
City
Jakarta Pusat
State/Province
Jakarta
ZIP/Postal Code
10430
Country
Indonesia
Individual Site Status
Enrolling by invitation

12. IPD Sharing Statement

Learn more about this trial

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

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