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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05990400
Other study ID # 23030293
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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