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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness and Safety of Platelet-rich Plasma and Topical 5% Minoxidil Combination Compared to Topical 5% Minoxidil Monotherapy in Male Androgenetic Alopecia

Conditions
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Androgenetic Alopecia

Intervention / Treatment
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* Combination Product: Platelet-Rich Plasma and Topical 5% Minoxidil
* Drug: Topical 5% Minoxidil


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>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<br>* The intervention group will receive three PRP injections during three months in addition to the topical 5% minoxidil.<br>|
| Active Comparator: Control Group<br>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<br>* The intervention group will receive topical 5% minoxidil as standard therapy for male androgenetic alopecia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective side effects | The patients subjective side effects from both intervention and control group will be reported using questionnaire during follow-up visits. Subjective side effects which will be reported consist of pain, itch, and burning sensation. Each subjective complaint will be reported as Yes or No. Other subjective side effects, if any, will also be noted under the term Other. | Three months | 
| Objective side effects | Researcher will report any objective side effects found during follow-up visits. The main objective side effects that will be reported are erythema and hypertrichosis. Each finding will be reported as Yes or No. Other objective side effects, if any, will be noted under the term Other. | Three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Platelet-Rich Plasma, Topical Minoxidil, Combination Therapy