Effectiveness and Safety of Topical Finasteride and Minoxidil Combination Compared to Topical Minoxidil for The Treatment of Male Androgenetic Alopecia

Study Overview
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Brief Summary
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A double-blind, randomized, controlled trial of 40 male patients with androgenetic alopecia was conducted. All subject were randomized to receive either combination of minoxidil 5% topical and finasteride 0,1% topical or minoxidil 5% topical

Detailed Description
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All subject were randomized to receive either combination of minoxidil 5% topical and finasteride 0,1% topical or minoxidil 5% topical The primary outcome was increase of the hair density and hair diameter (mean thickness) measured by trichoscan Measurements were done at baseline and every four weeks for twelve weeks. Additionally, side effects of therapy was also measured.

Official Title
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Effectiveness and Safety of Topical Finasteride and Minoxidil Combination Compared to Topical Minoxidil for The Treatment of Male Androgenetic Alopecia

Conditions
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Androgenetic Alopecia

Intervention / Treatment
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* Drug: Finasteride
* Drug: Minoxidil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male aged from 18-59 years diagnosed with androgenic alopecia Androgenic alopecia type III-V according to Hamilton-Norwood criteria Willing to participate in this research by signing the consent form after receiving an explanation from the researcher Willing to not cutting the hair nor coloring the hair during the study Exclusion Criteria: Diagnosed with other infectious or inflammatory skin disease in the scalp Using oral medications or vitamins that aim to increase the amount of hair in the last 1 month Using topical medication that aim to increase the amount of hair in the last 2 weeks Undergoing cosmetic procedure for AGA therapy such as low-level laser therapy (LLLT) procedures, platelet-rich plasma (PRP) injections, or microneedling within the last 3 months Have sexual disorder such as decreased libido Have a history of allergy or irritant contact dermatitis to the minoxidil and finasteride

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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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: Eligible subjects were randomized to receive either combination of minoxidil 5% topical and finasteride 0,1% topical or minoxidil 5% topical. The allocation sequence was generated with a computer by an analyst.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combination of minoxidil 5% topical and finasteride 0,1% topical group<br>Combination of minoxidil 5% solutio and finasteride 0,1% solutio which has administered topically | Drug: Finasteride<br>* finasteride topical 0,1%<br>Drug: Minoxidil<br>* minoxidil topical 5%<br>|
| Active Comparator: Minoxidil 5% topical group<br>Minoxidil 5% solutio which has administered topically | Drug: Minoxidil<br>* minoxidil topical 5%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hair density | Density of the hair is the number of hair strands per square inch of the scalp measured by trichoscan | 4 times of measurement in 3 months | 
| Hair diameter (mean thickness) | Hair diameter is the midline of the hair shaft measured by trichoscan | 4 times of measurement in 3 months | 
| Side effects | Incidence of side effects | 4 times of measurement in 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Velus hair percentage ( hair rate vellus) | Vellus hair is a hair that is less than 30 micrometer in diameter, lacks a medulla hair, and is 2 cm in length measured by trichoscan | 4 times of measurement in 3 months | 
| Terminal hair percentage (hair rate terminal) | Terminal hair is a hair that has a hair more than 60 micrometer, contains the medulla and can be up to 100 cm in length measured by trichoscan | 4 times of measurement in 3 months | 
| Dermoscopy | Dermoscopy is a non-invasive technique that allows more detailed examination of the scalp and hair shaft under magnification | 4 times of measurement in 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Finasteride topical, Minoxidil topical, Male androgenetic alopecia