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

Primary Purpose

Androgenetic Alopecia

Status

Recruiting

Phase

Phase 2

Locations

Indonesia

Study Type

Interventional

Intervention

Finasteride

Minoxidil

About this trial

This is an interventional treatment trial for Androgenetic Alopecia focused on measuring Finasteride topical, Minoxidil topical, Male androgenetic alopecia

Eligibility Criteria

18 Years - 59 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: Male aged from 18-59 years diagnosed with androgenic alopecia Androgenic alopecia type III-V according to Hamilton-Norwood criteria Willing to participate in this research by signing the consent form after receiving an explanation from the researcher Willing to not cutting the hair nor coloring the hair during the study Exclusion Criteria: Diagnosed with other infectious or inflammatory skin disease in the scalp Using oral medications or vitamins that aim to increase the amount of hair in the last 1 month Using topical medication that aim to increase the amount of hair in the last 2 weeks 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 Have sexual disorder such as decreased libido Have a history of allergy or irritant contact dermatitis to the minoxidil and finasteride

Sites / Locations

University IndonesiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Combination of minoxidil 5% topical and finasteride 0,1% topical group

Minoxidil 5% topical group

Arm Description

Combination of minoxidil 5% solutio and finasteride 0,1% solutio which has administered topically

Minoxidil 5% solutio which has administered topically

Outcomes

Primary Outcome Measures

Hair density

Density of the hair is the number of hair strands per square inch of the scalp measured by trichoscan

Hair diameter (mean thickness)

Hair diameter is the midline of the hair shaft measured by trichoscan

Side effects

Incidence of side effects

Secondary Outcome Measures

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

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

Dermoscopy

Dermoscopy is a non-invasive technique that allows more detailed examination of the scalp and hair shaft under magnification

Full Information

NCT ID

NCT05990400

First Posted

August 4, 2023

Last Updated

September 21, 2023

Sponsor

Indonesia University

1. Study Identification

Unique Protocol Identification Number

NCT05990400

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 1, 2023 (Actual)

Primary Completion Date

October 30, 2023 (Anticipated)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indonesia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Androgenetic Alopecia

Keywords

Finasteride topical, Minoxidil topical, Male androgenetic alopecia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

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.

Masking

ParticipantInvestigatorOutcomes 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.

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Combination of minoxidil 5% topical and finasteride 0,1% topical group

Arm Type

Experimental

Arm Description

Combination of minoxidil 5% solutio and finasteride 0,1% solutio which has administered topically

Arm Title

Minoxidil 5% topical group

Arm Type

Active Comparator

Arm Description

Minoxidil 5% solutio which has administered topically

Intervention Type

Drug

Intervention Name(s)

Finasteride

Intervention Description

finasteride topical 0,1%

Intervention Type

Drug

Intervention Name(s)

Minoxidil

Intervention Description

minoxidil topical 5%

Primary Outcome Measure Information:

Title

Hair density

Description

Density of the hair is the number of hair strands per square inch of the scalp measured by trichoscan

Time Frame

4 times of measurement in 3 months

Title

Hair diameter (mean thickness)

Description

Hair diameter is the midline of the hair shaft measured by trichoscan

Time Frame

4 times of measurement in 3 months

Title

Side effects

Description

Incidence of side effects

Time Frame

4 times of measurement in 3 months

Secondary Outcome Measure Information:

Title

Velus hair percentage ( hair rate vellus)

Description

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

Time Frame

4 times of measurement in 3 months

Title

Terminal hair percentage (hair rate terminal)

Description

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

Time Frame

4 times of measurement in 3 months

Title

Dermoscopy

Description

Dermoscopy is a non-invasive technique that allows more detailed examination of the scalp and hair shaft under magnification

Time Frame

4 times of measurement in 3 months

10. Eligibility

Sex

Male

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

59 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Farah F Lubis, MD

Phone

081385088998

farahfaulinlubis@gmail.com

Facility Information:

Facility Name

University Indonesia

City

Jakarta

State/Province

Other (Non U.s.)

ZIP/Postal Code

10250

Country

Indonesia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Farah F Lubis, MD

Phone

081385088998

farahfaulinlubis@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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