Clinical trial NCT05990400: 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
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Androgenetic Alopecia
Keywords: Finasteride topical
Minoxidil topical
Male androgenetic alopecia
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Hair density
timeFrame: 4 times of measurement in 3 months
measure: Hair diameter (mean thickness)
timeFrame: 4 times of measurement in 3 months
measure: Side effects
timeFrame: 4 times of measurement in 3 months
Secondary outcomes:
measure: Velus hair percentage ( hair rate vellus)
timeFrame: 4 times of measurement in 3 months
measure: Terminal hair percentage (hair rate terminal)
timeFrame: 4 times of measurement in 3 months
measure: Dermoscopy
timeFrame: 4 times of measurement in 3 months
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: University Indonesia
state: Other (Non U.s.)
Study officials:
References: