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

University of Indonesia (UI)

Status and phase: Active, not recruiting; Phase 4

Conditions: Androgenetic Alopecia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06043349

23020292

Details and patient eligibility

About

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?

Full 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.

Enrollment: 36 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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.

Treatment:

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

Control Group

Active Comparator group

Description:

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.

Treatment:

Drug: Topical 5% Minoxidil