Clinical trial NCT06043349: Effectiveness and Safety of Platelet-rich Plasma and Topical 5% Minoxidil Combination in Male Androgenetic Alopecia
Official title: Effectiveness and Safety of Platelet-rich Plasma and Topical 5% Minoxidil Combination Compared to Topical 5% Minoxidil Monotherapy in Male Androgenetic Alopecia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Androgenetic Alopecia
Keywords: Platelet-Rich Plasma
Topical Minoxidil
Combination Therapy
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a controlled clinical trial on male androgenetic alopecia. Research subjects will be randomly divided into two groups. The first group will receive a combination therapy of PRP injection and topical 5% minoxidil, while the second group will receive topical 5% minoxidil as monotherapy.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn about the effectiveness and safety of platelet-rich plasma (PRP) and topical 5% minoxidil combination therapy compared with topical 5% minoxidil monotherapy in male androgenetic alopecia.

The main questions it aims to answer are:

* Is there a difference in average change of hair density between groups that were given a combination of PRP injection and topical minoxidil compared to topical minoxidil as monotherapy?
* Is there a difference in average change of hair thickness between groups that were given a combination of PRP and topical minoxidil compared to topical minoxidil as monotherapy?
* Are there any differences in side effects between groups that were given combination of PRP and topical minoxidil compared to topical minoxidil as monotherapy?

Detailed description: The trial will be held for three months in Jakarta, Indonesia. Participants are required to undergo hair examinations every 4 weeks, for a total of 4 visits. Researchers will compare groups that were given a combination of PRP and topical minoxidil compared to topical minoxidil alone as a control group. Hair density, hair thickness, and overall side effects of treatment will be measured at each visit.

Eligibility criteria: Inclusion Criteria:

* Men between 18 and 50 years old
* Diagnosed with grade III-VI androgenetic alopecia based on Hamilton-Norwood scale
* Willing to be the research subject and make regular follow-up visits.

Exclusion Criteria:

* Conditions of baldness other than androgenetic alopecia based on anamnesis and physical examination, namely telogen effluvium, alopecia areata, trichotillomania, syphilis secondary, systemic lupus erythematosus, alopecia due to chemotherapy, autoimmune, or malignancy.
* Taking oral medications or vitamins that aim to increase the amount of hair in the last 1 month.
* Using topical medication that aims to increase the amount of hair in the last 2 weeks.
* Suffering from active bacterial, viral, or fungal infections of the scalp.
* Underwent cosmetic procedures for androgenetic alopecia treatment (such as PRP injections, laser procedures, or microneedle) within the last 3 months prior to the study.
* History of keloids.
* History of blood clotting disorders.

Primary outcomes:
measure: Hair Density
timeFrame: Three months
measure: Hair Thickness
timeFrame: Three months
Secondary outcomes:
measure: Subjective side effects
timeFrame: Three months
measure: Objective side effects
timeFrame: Three months
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Dr. Cipto Mangunkusumo National General Hospital
state: Greater Jakarta Area
Study officials:
affiliation: Faculty of Medicine, University of Indonesia
name: Adhika A Lestari, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elena EP, Irina OS. Combination therapy with platelet-rich plasma and minoxidil leads to better clinical results than monotherapy with these methods in men with androgenetic alopecia. Int J Trichology. 2022 Jan-Feb;14(1):1-7. doi: 10.4103/ijt.ijt_50_19. Epub 2022 Feb 1.
citation: Singh SK, Kumar V, Rai T. Comparison of efficacy of platelet-rich plasma therapy with or without topical 5% minoxidil in male-type baldness: A randomized, double-blind placebo control trial. Indian J Dermatol Venereol Leprol. 2020 Mar-Apr;86(2):150-157. doi: 10.4103/ijdvl.IJDVL_589_18.