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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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". |
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Inclusion Criteria:
Exclusion Criteria:
Male patient with androgenetic alopecia
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| Name | Affiliation | Role |
|---|---|---|
| Adhika A Lestari, MD | Faculty of Medicine, University of Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Cipto Mangunkusumo National General Hospital | Jakarta Pusat | Greater Jakarta Area | 10430 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35300100 | Background | 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. | |
| 31823902 | Result | 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. |
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D008914 | Minoxidil |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
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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.
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| Topical 5% Minoxidil | Drug | The intervention group will receive topical 5% minoxidil as standard therapy for male androgenetic alopecia. |
|
| 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 |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |