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

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

Indonesia

Study Type

Interventional

Intervention

Platelet-Rich Plasma Injections (PRP) on the Scalp

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

NCT ID

NCT05681897

First Posted

December 20, 2022

Last Updated

January 3, 2023

Sponsor

Indonesia University

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

Alopecia, Androgenetic

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial