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

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ClinicalTrials.gov Identifier: NCT05990400
Recruitment Status : Recruiting
First Posted : August 14, 2023
Last Update Posted : September 22, 2023
Sponsor:
Information provided by (Responsible Party):
Farah Faulin Al Fauz Lubis, Indonesia University

Study Description
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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

Condition or disease Intervention/treatment Phase
Androgenetic Alopecia Drug: Finasteride Drug: Minoxidil Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Triple (Participant, Investigator, Outcomes 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.
Primary Purpose: Treatment
Official Title: Effectiveness and Safety of Topical Finasteride and Minoxidil Combination Compared to Topical Minoxidil for The Treatment of Male Androgenetic Alopecia
Actual Study Start Date : May 1, 2023
Estimated Primary Completion Date : October 30, 2023
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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%


Outcome Measures
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Primary Outcome Measures :
  1. Hair density [ Time Frame: 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

  2. Hair diameter (mean thickness) [ Time Frame: 4 times of measurement in 3 months ]
    Hair diameter is the midline of the hair shaft measured by trichoscan

  3. Side effects [ Time Frame: 4 times of measurement in 3 months ]
    Incidence of side effects


Secondary Outcome Measures :
  1. Velus hair percentage ( hair rate vellus) [ Time Frame: 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

  2. Terminal hair percentage (hair rate terminal) [ Time Frame: 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

  3. Dermoscopy [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05990400


Contacts
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Contact: Farah F Lubis, MD 081385088998 farahfaulinlubis@gmail.com

Locations
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Indonesia
University Indonesia Recruiting
Jakarta, Other (Non U.s.), Indonesia, 10250
Contact: Farah F Lubis, MD    081385088998    farahfaulinlubis@gmail.com   
Sponsors and Collaborators
Indonesia University
More Information
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Responsible Party: Farah Faulin Al Fauz Lubis, MD, Indonesia University
ClinicalTrials.gov Identifier: NCT05990400    
Other Study ID Numbers: 23030293
First Posted: August 14, 2023    Key Record Dates
Last Update Posted: September 22, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Farah Faulin Al Fauz Lubis, Indonesia University:
Finasteride topical
Minoxidil topical
Male androgenetic alopecia
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Minoxidil
Finasteride
Antihypertensive Agents
 Vasodilator Agents
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Urological Agents