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

Androgenetic Alopecia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05990400
• Other study ID #: 23030293
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: May 1, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: September 2023
• Source: Indonesia University
• Contact: Farah F Lubis, MD
• Phone: 081385088998
• Email: farahfaulinlubis[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Androgenetic Alopecia

Intervention

Drug:
• Finasteride
finasteride topical 0,1%
• Minoxidil
minoxidil topical 5%

Locations

Country	Name	City	State
Indonesia	University Indonesia	Jakarta	Other (Non U.s.)

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Hair diameter (mean thickness)	Hair diameter is the midline of the hair shaft measured by trichoscan	4 times of measurement in 3 months
Primary	Side effects	Incidence of side effects	4 times of measurement in 3 months
Secondary	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
Secondary	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
Secondary	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