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

NCT05990400 | Unknown Phase 2

• 1 other identifier: 23030293
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Androgenetic Alopecia

Keywords

Finasteride topical; Minoxidil topical; Male androgenetic alopecia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Velus hair percentage ( hair rate vellus)

  4 times of measurement in 3 months

• Terminal hair percentage (hair rate terminal)

  4 times of measurement in 3 months

• Dermoscopy

  4 times of measurement in 3 months

Study Arms (2)

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

EXPERIMENTAL

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

Drug: Finasteride; Drug: Minoxidil

Minoxidil 5% topical group

ACTIVE COMPARATOR

Minoxidil 5% solutio which has administered topically

Drug: Minoxidil

Interventions

Finasteride DRUG

finasteride topical 0,1%

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

Minoxidil DRUG

minoxidil topical 5%

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

Eligibility Criteria

• Age: 18 Years - 59 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

University Indonesia

Jakarta, Other (Non U.s.), 10250, Indonesia

RECRUITING

MeSH Terms

Conditions

Alopecia

Interventions

Finasteride; Minoxidil

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Azasteroids; Steroids, Heterocyclic; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Central Study Contacts

Farah F Lubis, MD

CONTACT

081385088998; farahfaulinlubis@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: 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.

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 14, 2023
• Study Start: May 1, 2023
• Primary Completion: October 30, 2023
• Study Completion: December 30, 2023
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)