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

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

Study Overview

• Status: Recruiting
• Conditions: Androgenetic Alopecia
• Intervention / Treatment: Drug: Finasteride; Drug: Minoxidil

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Farah F Lubis, MD; Phone Number: 081385088998; Email: farahfaulinlubis@gmail.com

Study Locations

• Indonesia
  • Other (Non U.s.)
    • Jakarta, Other (Non U.s.), Indonesia, 10250
      • Recruiting
      • University Indonesia
      • Contact: Farah F Lubis, MD; Phone Number: 081385088998; Email: farahfaulinlubis@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combination of minoxidil 5% topical and finasteride 0,1% topical group; Combination of minoxidil 5% solutio and finasteride 0,1% solutio which has administered topically	Drug: Finasteride; finasteride topical 0,1%; Drug: Minoxidil; minoxidil topical 5%
Active Comparator: Minoxidil 5% topical group; Minoxidil 5% solutio which has administered topically	Drug: Minoxidil; minoxidil topical 5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Hair diameter (mean thickness)	Hair diameter is the midline of the hair shaft measured by trichoscan	4 times of measurement in 3 months
Side effects	Incidence of side effects	4 times of measurement in 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Indonesia University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): October 30, 2023
• Study Completion (Estimated): December 30, 2023

Study Registration Dates

• First Submitted: August 4, 2023
• First Submitted That Met QC Criteria: August 4, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Finasteride topical; Minoxidil topical; Male androgenetic alopecia
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Steroid Synthesis Inhibitors; 5-alpha Reductase Inhibitors; Finasteride; Minoxidil
• Other Study ID Numbers: 23030293

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No