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

Phase 2

Recruiting

• Conditions: Androgenetic Alopecia
• Interventions: Drug: Finasteride; Drug: Minoxidil

• Registration Number: NCT05990400
• Lead Sponsor: Indonesia University

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.

Study Timeline

• Study Start: 2023-05-01
• Study First Submitted: 2023-08-04
• Study First Submitted QC: 2023-08-04
• Study First Posted: 2023-08-14
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-22
• Primary Completion: 2023-10-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination of minoxidil 5% topical and finasteride 0,1% topical group	Minoxidil	Combination of minoxidil 5% solutio and finasteride 0,1% solutio which has administered topically
Combination of minoxidil 5% topical and finasteride 0,1% topical group	Finasteride	Combination of minoxidil 5% solutio and finasteride 0,1% solutio which has administered topically
Minoxidil 5% topical group	Minoxidil	Minoxidil 5% solutio which has administered topically

Primary Outcome Measures

Name	Time	Method
Side effects	4 times of measurement in 3 months	Incidence of side effects
Hair density	4 times of measurement in 3 months	Density 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 months	Hair diameter is the midline of the hair shaft measured by trichoscan

Secondary Outcome Measures

Name	Time	Method
Terminal hair percentage (hair rate terminal)	4 times of measurement in 3 months	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
Dermoscopy	4 times of measurement in 3 months	Dermoscopy 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 months	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

Trial Locations

Locations (1)

University Indonesia; 🇮🇩 Jakarta, Other (Non U.s.), Indonesia