Effectiveness of Combination Therapy of Microneedling and Minoxidil in Androgenetic Alopecia of Indonesian Men

Study Overview
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Brief Summary
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The goal of this clinical trial is to compare the effectiveness of combination therapy of microneedling and minoxidil in androgenetic alopecia of Indonesian men. The main questions it aims to answer are: Is there an increase in hair density with combination therapy of microneedling and minoxidil versus minoxidil monotherapy? Is there an increase in hair diameter with combination therapy of microneedling and minoxidil versus minoxidil monotherapy? Participants will be divided into 2 groups. The first one will receive minoxidil monotherapy, and the second one will receive a combination therapy of microneedling and minoxidil. Researchers will compare those 2 groups to see if there is a difference of effectiveness based on hair density and diameter.

Official Title
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Effectiveness of Combination Therapy of Microneedling and Minoxidil in Androgenetic Alopecia of Indonesian Men

Conditions
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Androgenetic Alopecia

Intervention / Treatment
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* Drug: Minoxidil 5% Topical Solution
* Device: microneedling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male Indonesian Age 18-59 years Diagnosis of androgenetic alopecia Hamilton-Norwood type III-IV Exclusion Criteria: Use of minoxidil or finasteride topical 1 month prior Use of minoxidil or finasteride oral 1 month prior Skin infection in the treatment area Cosmetic procedures for the treatment of alopecia androgenetic such as platelet rich plasma, laser therapy,or microneedling 3 months prior History of keloid

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Minoxidil 5% solution<br>Patients will receive minoxidil 5%, twice a day, for a total duration of 12 weeks. | Drug: Minoxidil 5% Topical Solution<br>* Patient will be given minoxidil 5% topical solution, twice a day for 12 weeks<br>|
| Experimental: Combination therapy of microneedling and minoxidil 5% solution<br>Patients will receive a combination therapy of microneedling and minoxidil 5%. Minoxidil 5%, will be given twice a day for a total duration of 12 weeks. The microneedling treatment will be given every 4 weeks (week 0, week 4, week 8)for a total duration of 12 weeks. | Drug: Minoxidil 5% Topical Solution<br>* Patient will be given minoxidil 5% topical solution, twice a day for 12 weeks<br>Device: microneedling<br>* Patient will be given microneedling treatment every 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Density of hair | Increase density of hair in alopecia androgenetic patient | 12 weeks | 
| Diameter of hair | Increase diameter of hair in alopecia androgenetic patient | 12 weeks |