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

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05990400
Enrollment
40
Registered
2023-08-14
Start date
2023-05-01
Completion date
2023-12-30
Last updated
2023-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Androgenetic Alopecia

Keywords

Finasteride topical, Minoxidil topical, Male androgenetic alopecia

Brief summary

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

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.

Interventions

DRUGFinasteride

finasteride topical 0,1%

minoxidil topical 5%

Sponsors

Indonesia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

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.

Intervention 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.

Eligibility

Sex/Gender
MALE
Age
18 Years to 59 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Hair density4 times of measurement in 3 monthsDensity of the hair is the number of hair strands per square inch of the scalp measured by trichoscan
Hair diameter (mean thickness)4 times of measurement in 3 monthsHair diameter is the midline of the hair shaft measured by trichoscan
Side effects4 times of measurement in 3 monthsIncidence of side effects

Secondary

MeasureTime frameDescription
Terminal hair percentage (hair rate terminal)4 times of measurement in 3 monthsTerminal 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
Dermoscopy4 times of measurement in 3 monthsDermoscopy is a non-invasive technique that allows more detailed examination of the scalp and hair shaft under magnification
Velus hair percentage ( hair rate vellus)4 times of measurement in 3 monthsVellus 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

Countries

Indonesia

Contacts

Primary ContactFarah F Lubis, MD
farahfaulinlubis@gmail.com081385088998

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026