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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2023-12-30

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

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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.

Conditions

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Androgenetic Alopecia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Triple (Participant, Investigator, Outcomes Assessor) The allocation sequence was generated with a computer by an analyst. The allocation sequence was concealed from the investigators, outcomes assessor, and subjects.

Study Groups

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Combination of minoxidil 5% topical and finasteride 0,1% topical group

Combination of minoxidil 5% solutio and finasteride 0,1% solutio which has administered topically

Group Type EXPERIMENTAL

Finasteride

Intervention Type DRUG

finasteride topical 0,1%

Minoxidil

Intervention Type DRUG

minoxidil topical 5%

Minoxidil 5% topical group

Minoxidil 5% solutio which has administered topically

Group Type ACTIVE_COMPARATOR

Minoxidil

Intervention Type DRUG

minoxidil topical 5%

Interventions

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Finasteride

finasteride topical 0,1%

Intervention Type DRUG

Minoxidil

minoxidil topical 5%

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male aged from 18-59 years diagnosed with androgenic alopecia
2. Androgenic alopecia type III-V according to Hamilton-Norwood criteria
3. Willing to participate in this research by signing the consent form after receiving an explanation from the researcher
4. Willing to not cutting the hair nor coloring the hair during the study

Exclusion Criteria

1. Diagnosed with other infectious or inflammatory skin disease in the scalp
2. Using oral medications or vitamins that aim to increase the amount of hair in the last 1 month
3. Using topical medication that aim to increase the amount of hair in the last 2 weeks
4. 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
5. Have sexual disorder such as decreased libido
6. Have a history of allergy or irritant contact dermatitis to the minoxidil and finasteride

Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes