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

Alopecia, Androgenetic Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05681897
• Other study ID #: 876/UN2.F1/ETIK/PPM.00.02/2
• Status: Recruiting
• Phase: N/A
• Start date: February 2023
• Est. completion date: February 2023

Study information

• Verified date: January 2023
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 25 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Alopecia, Androgenetic

Intervention

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.

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo General Hospital	Jakarta Pusat	DKI Jakarta
Indonesia	Universitas Indonesia	Jakarta Pusat	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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