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

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: Recruiting
• Conditions: Alopecia, Androgenetic
• Intervention / Treatment: Procedure: Platelet-Rich Plasma Injections (PRP) on the Scalp

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: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • Recruiting
      • Cipto Mangunkusumo General Hospital
      • Contact: Lili Legiawati, MD, PhD; Phone Number: +62816707990; Email: lililegiawati@yahoo.com
      • 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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)	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.	6 weeks

Collaborators and Investigators

• Sponsor: Indonesia University

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2023
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: December 20, 2022
• First Submitted That Met QC Criteria: January 3, 2023
• First Posted (Actual): January 12, 2023

Study Record Updates

• Last Update Posted (Actual): January 12, 2023
• Last Update Submitted That Met QC Criteria: January 3, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Androgenetic Alopecia; Platelet-rich plasma; Centrifugation; Thrombocyte
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Antihypertensive Agents; Vasodilator Agents; Minoxidil
• Other Study ID 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