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

NCT ID: NCT06043349

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2023-09-30

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?

Detailed Description

The trial will be held for three months in Jakarta, Indonesia. Participants are required to undergo hair examinations every 4 weeks, for a total of 4 visits. Researchers will compare groups that were given a combination of PRP and topical minoxidil compared to topical minoxidil alone as a control group. Hair density, hair thickness, and overall side effects of treatment will be measured at each visit.

Conditions

Androgenetic Alopecia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Group

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.

Group Type: EXPERIMENTAL

Platelet-Rich Plasma and Topical 5% Minoxidil

Intervention Type: COMBINATION_PRODUCT

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

Control Group

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.

Group Type: ACTIVE_COMPARATOR

Topical 5% Minoxidil

Intervention Type: DRUG

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

Interventions

Platelet-Rich Plasma and Topical 5% Minoxidil

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

Intervention Type: COMBINATION_PRODUCT

Topical 5% Minoxidil

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Adhika Ayu Lestari

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adhika A Lestari, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, University of Indonesia

Locations

Dr. Cipto Mangunkusumo National General Hospital

Jakarta Pusat, Greater Jakarta Area, Indonesia

Countries

Indonesia

References

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.

Reference Type: BACKGROUND

PMID: 35300100 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31823902 (View on PubMed)

Other Identifiers

23020292

Identifier Type: -

Identifier Source: org_study_id