Effectiveness and Safety of Platelet-rich Plasma and Topical 5% Minoxidil Combination in Male Androgenetic Alopecia

NCT06043349 | Unknown Phase 4

• 1 other identifier: 23020292
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn about the effectiveness and safety of platelet-rich plasma (PRP) and topical 5% minoxidil combination therapy compared with topical 5% minoxidil monotherapy in male androgenetic alopecia. The main questions it aims to answer are:

• Is there a difference in average change of hair density between groups that were given a combination of PRP injection and topical minoxidil compared to topical minoxidil as monotherapy?
• Is there a difference in average change of hair thickness between groups that were given a combination of PRP and topical minoxidil compared to topical minoxidil as monotherapy?
• Are there any differences in side effects between groups that were given combination of PRP and topical minoxidil compared to topical minoxidil as monotherapy?

Conditions

Androgenetic Alopecia

Keywords

Platelet-Rich Plasma; Topical Minoxidil; Combination Therapy

Outcome Measures

Primary Outcomes (2)

• Hair Density

  Change in average hair density will be reported in /cm2

  Three months

• Hair Thickness

  Change in average hair thickness will be reported in milimeters

  Three months

Secondary Outcomes (2)

• Subjective side effects

  Three months

• Objective side effects

  Three months

Study Arms (2)

Intervention Group

EXPERIMENTAL

The first group, called the intervention group, will receive a combination therapy of platelet-rich plasma injection (PRP) with topical 5% minoxidil for three months. PRP injection will be given every 4 weeks with a total of three injections. Respondents will be instructed to apply topical minoxidil twice daily for three months.

Combination Product: Platelet-Rich Plasma and Topical 5% Minoxidil

Control Group

ACTIVE COMPARATOR

The second group (control group) will receive topical 5% minoxidil as standard therapy. Respondents will be instructed to apply topical minoxidil twice daily for three months.

Drug: Topical 5% Minoxidil

Interventions

Platelet-Rich Plasma and Topical 5% Minoxidil COMBINATION_PRODUCT

The intervention group will receive three PRP injections during three months in addition to the topical 5% minoxidil.

Intervention Group

Topical 5% Minoxidil DRUG

The intervention group will receive topical 5% minoxidil as standard therapy for male androgenetic alopecia.

Control Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Male patient with androgenetic alopecia
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men between 18 and 50 years old
• Diagnosed with grade III-VI androgenetic alopecia based on Hamilton-Norwood scale
• Willing to be the research subject and make regular follow-up visits.

You may not qualify if:

• Conditions of baldness other than androgenetic alopecia based on anamnesis and physical examination, namely telogen effluvium, alopecia areata, trichotillomania, syphilis secondary, systemic lupus erythematosus, alopecia due to chemotherapy, autoimmune, or malignancy.
• Taking oral medications or vitamins that aim to increase the amount of hair in the last 1 month.
• Using topical medication that aims to increase the amount of hair in the last 2 weeks.
• Suffering from active bacterial, viral, or fungal infections of the scalp.
• Underwent cosmetic procedures for androgenetic alopecia treatment (such as PRP injections, laser procedures, or microneedle) within the last 3 months prior to the study.
• History of keloids.
• History of blood clotting disorders.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Dr. Cipto Mangunkusumo National General Hospital

Jakarta Pusat, Greater Jakarta Area, 10430, Indonesia

Location

Related Publications (2)

• Elena EP, Irina OS. Combination therapy with platelet-rich plasma and minoxidil leads to better clinical results than monotherapy with these methods in men with androgenetic alopecia. Int J Trichology. 2022 Jan-Feb;14(1):1-7. doi: 10.4103/ijt.ijt_50_19. Epub 2022 Feb 1.

  PMID: 35300100 BACKGROUND

• Singh SK, Kumar V, Rai T. Comparison of efficacy of platelet-rich plasma therapy with or without topical 5% minoxidil in male-type baldness: A randomized, double-blind placebo control trial. Indian J Dermatol Venereol Leprol. 2020 Mar-Apr;86(2):150-157. doi: 10.4103/ijdvl.IJDVL_589_18.

  PMID: 31823902 RESULT

MeSH Terms

Conditions

Alopecia

Interventions

Minoxidil

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Adhika A Lestari, MD

  Faculty of Medicine, University of Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: This study is a controlled clinical trial on male androgenetic alopecia. Research subjects will be randomly divided into two groups. The first group will receive a combination therapy of PRP injection and topical 5% minoxidil, while the second group will receive topical 5% minoxidil as monotherapy.

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 21, 2023
• Study Start: June 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: September 30, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)