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

University of Indonesia (UI)

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Androgenetic Alopecia

Treatments: Drug: Minoxidil; Drug: Finasteride

Study type: Interventional

Funder types: Other

Identifiers

NCT05990400

23030293

Details and patient eligibility

About

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

Full description

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.

Enrollment: 40 estimated patients

Sex: Male

Ages: 18 to 59 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

Drug: Finasteride

Drug: Minoxidil

Minoxidil 5% topical group

Active Comparator group

Description:

Minoxidil 5% solutio which has administered topically

Treatment:

Drug: Minoxidil