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

NCT ID: NCT05681897

Last Updated: 2023-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-28

Study Completion Date

2023-02-28

Brief Summary

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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

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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

Conditions

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Alopecia, Androgenetic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
this is a double-blind masking study

Study Groups

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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%)

Group Type OTHER

Platelet-Rich Plasma Injections (PRP) on the Scalp

Intervention Type PROCEDURE

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

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%)

Group Type ACTIVE_COMPARATOR

Platelet-Rich Plasma Injections (PRP) on the Scalp

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Regrou Forte (5% Minoxidil solution)

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

59 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Dr. dr. Lili Legiawati, SpKK(K)

National-board certified dermatologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cipto Mangunkusumo General Hospital

Jakarta Pusat, DKI Jakarta, Indonesia

Site Status RECRUITING

Universitas Indonesia

Jakarta Pusat, Jakarta Special Capital Region, Indonesia

Site Status ENROLLING_BY_INVITATION

Countries

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Indonesia

Facility Contacts

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Lili Legiawati, MD, PhD

Role: primary

+62816707990

References

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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.

Reference Type DERIVED
PMID: 38125672 (View on PubMed)

Other Identifiers

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876/UN2.F1/ETIK/PPM.00.02/2

Identifier Type: -

Identifier Source: org_study_id

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