NCT05681897

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 12, 2023

Completed
20 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

January 12, 2023

Status Verified

January 1, 2023

Enrollment Period

Same day

First QC Date

December 20, 2022

Last Update Submit

January 3, 2023

Conditions

Alopecia, Androgenetic

Keywords

Androgenetic AlopeciaCentrifugationPlatelet-rich plasmaThrombocyte

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

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%)

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%)

Procedure: Platelet-Rich Plasma Injections (PRP) on the Scalp

Interventions

Platelet-Rich Plasma Injections (PRP) on the ScalpPROCEDURE

each subject will be treated with 3x PRP injections on the scalp with 2 weeks interval in addition to daily minoxidil administration.

Also known as: Regrou Forte (5% Minoxidil solution)
Double Spin GroupSingle Spin Group

Eligibility Criteria

Age25 Years - 59 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cipto Mangunkusumo General Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

RECRUITING

Universitas Indonesia

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

ENROLLING BY INVITATION

Related Publications (1)

  • 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.

    PMID: 38125672DERIVED

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
this is a double-blind masking study
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
National-board certified dermatologist

Study Record Dates

First Submitted

December 20, 2022

First Posted

January 12, 2023

Study Start

February 1, 2023

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

January 12, 2023

Record last verified: 2023-01

Locations

ID(2)